Hyperhidrosis
Conditions
Keywords
Neuromuscular Agents, Botulinum Toxin Type A, Sweating, Sweat Gland Disease, Axillary Hyperhidrosis, Skin Disease
Brief summary
The primary objective of this study is to demonstrate superiority of single treatment of GSK1358820 (hereinafter, referred to as BOTOX®) over placebo in terms of the efficacy of treatment with BOTOX® 50 U in each axilla (100 U in total for each patient) as intradermal injections based on gravimetric assessment (measurement of spontaneous axillary sweat production) for axillary hyperhidrosis.
Interventions
DRUGGSK1358820
Onabotulinum toxin type A
DRUGPlacebo
Placebo
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
\<At start of the screening phase (Visit 1)\> * At least 50 mg of spontaneous resting axillary sweat production in each axilla measured gravimetrically at room temperature/humidity (20 - 25.6°C/20-80%) over a period of 5 minutes. (Patients should be at rest for at least 30 minutes after physical exercise including walking.) * Patients with primary axillary hyperhidrosis whose excessive sweating in each axillae interferes daily life activities and whose Hyperhidrosis Disease Severity Scale (HDSS) score is 3 or 4. * Age of 20 to 75 years at the time of informed consent. * Both genders are eligible to enrol in the study. For men, only those who can practice contraception during the study period are eligible. Women of childbearing potential may be enrolled only if they have negative pregnancy test both in the screening period and just before treatment. Women of childbearing potential must agree to use one or more of the following reliable contraceptive measures throughout the study period: \*: Abstinence, oral contraceptives, progesterone injection, levonorgestrel implant, estrogen ring, transdermal contraceptives, intrauterine device, vasectomized partner, and double-barrier contraception (condom or diaphragm with spermicidal jelly/film). * QTc \<450 msec, or QTc \<480 msec in patients with bundle branch block. (QTc should be determined on one beat on echocardiogram (ECG) or determined by average on consecutive three beats.) * Willing and able to provide written informed consent. \<At start of the treatment phase (Visit 2)\> * At least 50 mg of spontaneous resting axillary sweat production in each axilla measured gravimetrically at room temperature/humidity (20 - 25.6°C/20-80%) over a period of 5 minutes. (Patients should be at rest for at least 30 minutes after physical exercise including walking.) * Patients with primary axillary hyperhidrosis whose excessive sweating in each axillae interferes daily life activities and whose HDSS score is 3 or 4. * Asparate aminotransferase (AST) and Alanine aminotransferase (ALT) \< 2 x upper limit of normal (ULN), Alkaline phosphatase (ALP) and bilirubin \<= 1.5 x ULN at Visit 1 (Free bilirubin \>= 1.5 × ULN will not directly lead to study discontinuation if bilirubin fraction test result of direct bilirubin \<35% is available.)
Exclusion criteria
\<At start of the screening phase (Visit 1)\> * Any systemic neuromuscular junction disorder (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis). * Previous botulinum toxin treatment. * Expected use of botulinum toxin for the treatment of any other disease during the study period. * Known allergy to any of the components in the investigational product or iodine. * Secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma and malaria. * Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery. * Concurrent use of antibiotics that may interfere with neuromuscular junction function, for example, aminoglycoside antibiotics (e.g., gentamicin sulfate, fradiomycin sulfate), polypeptide antibiotics (e.g., polymixin B sulfate), tetracycline antibiotics, and lincomycin antibiotics, except for those contained in topical antimicrobials. * Concurrent use of muscle relaxants (e.g., tubocurarin chloride hydrochloride hydrate, dantrolene sodium hydrate) or drugs that may have a muscle relaxant action (e.g. spectinomycin hydrochloride hydrate, antispasmogenics including baclofen, benzodiazepines and benzodiazepine-like drugs, benzamides). * Chronic respiratory disorder. * Serious muscle weakness or atrophy. * Angle closure glaucoma or its precipitation (narrow angle). * Dermal disorder including infection at anticipated injection sites in either axilla. * Subject has serious physical symptom(s) (i.e., cardiac / hepatic / renal / hematopoietic disorder). The index of seriousness is Grade 3 of criteria for classification of seriousness of adverse drug reactions to pharmaceutical products, etc. : Appendix 3 (Pharmaceutical Affairs bureau / Pharmaceutical and Chemical Safety Division (PAB / PSD) Notification No.80 in 1992). * Anticipated need for surgery or hospitalization during the study period. * Women who are pregnant, lactating, possibly pregnant or planning a pregnancy during the study period. * Participation in another clinical study within 6 months of study entry or planned participation in another clinical study after entry to this study. * Psychiatry disorder or cognitive disorder that may affect the patient's ability to give informed consent or to follow specified study procedures. * History of alcohol or drug abuse. * Any condition or situation that, in the investigator's or subinvestigator's opinion, may interfere with the patient's participation in the study. \<At start of the treatment phase (Visit 2)\> * Use of cholinomimetics, anticholinergics, antiperspirants containing aluminum chloride and deodorants, any oral herbal medicine treatments or any other topical treatments for hyperhidrosis within 7 days prior to study treatment.. * Underarm hair removed within 12 hours prior to study treatment or not removed sufficiently. * Any condition or situation that, in the investigator's or subinvestigator's opinion, may interfere with the patient's participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Responders Assessed by Gravimetric Measurement at Week 4 in the First Treatment Phase | Week 4 | A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 0 (Baseline); Weeks 1, 4, 8, 12, 16, 20, and 24 | A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. |
| Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 0 (Baseline); and Weeks 1, 4, 8, 12, 16, 20, and 24 | A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. Percent change from Baseline was calculated as follows: (mean weight at each visit minus mean weight at Baseline) \* 100/mean weight at Baseline. |
| Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 | The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. A responder was defined as a participant whose change from Baseline was equal to or less than -2. |
| Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 | The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. Change from Baseline in HDSS was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 | The DLQI is a dermatology-specific, participant-answered questionnaire that allows for comparison of Quality of Life (QOL). DLQI total score (0-30) is a sum of the scores of 6 domains: Symptoms and Feelings, Daily Activities, Leisure, and Personal Relationships (score=0-6 for each); Work and School, and Treatment (score=0-3 for both; 0=not at all or not applicable, 3=very much or yes only in one item of Work and School). A lower score indicates better condition. Change from Baseline in the DLQI total score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Symptoms and Feelings domain consists of 2 questions (Item 1 and Item 2). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Symptoms and Feelings domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Daily Activities domain consists of 2 questions (Item 3 and Item 4). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Daily Activities domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Leisure domain consists of 2 questions (Item 5 and Item 6). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Leisure domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Work and School domain consists of 1 question (Item 7). The score for this item ranges from 0 (not at all or not applicable) to 3 (yes); therefore, the possible total score for the Work and School domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Personal Relationships domain consists of 2 questions (Item 8 and Item 9). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Personal Relationships domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Treatment domain consists of 1 question (Item 10). The score for this item ranges from 0 (not at all or not applicable) to 3 (very much); therefore, the total possible score for the Treatment domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 1, participants were asked how itchy, sore, painful or stinging their skin was over the last week. The scores for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 1 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 2, participants were asked how embarrassed or self conscious they were because of their skin over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 2 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 3, participants were asked how much their skin interfered with them going shopping or looking after their home or garden over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 3 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 4, participants were asked how much their skin interfered with the clothes they wore over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 4 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 5, participants were asked how much their skin affected any social or leisure activities over the last week. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 5 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 6, participants were asked how much their skin made it difficult to do any sports over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 6 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 7, participants were asked if their skin prevented them from working or studying over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (yes). Item 7 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 8, participants were asked how much their skin created problems with their partner or any of their close friends or relatives over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 8 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 9, participants were asked how much their skin caused any sexual difficulties over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 9 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 10, participants were asked how much of a problem the treatment for their skin was, for example, by making their home messy, or by taking up time. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 10 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline. |
| Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 | The participant's global assessment of treatment satisfaction is a method used to evaluate a participant's treatment satisfaction. Participants rated any improvement or worsening of their symptoms compared to Baseline by using the following 9-point scale: +4, Complete abolishment of signs and symptoms; +3, Marked improvement; +2, Moderate improvement; +1, Slight improvement; 0, Unchanged; -1, Slight worsening; -2, Moderate worsening; -3, Marked worsening; and -4, Very marked worsening. |
| Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase | A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline (Week 0 in the Second Treatment Phase) in mean weight of axillary sweating. |
| Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Baseline (Week 0); Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase | A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. |
| Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Baseline (Week 0); and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase | A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. Percent change from Baseline in the Second Treatment phase was calculated as follows: (mean weight at each visit minus mean weight at Baseline in the Second Treatment Phase) \* 100/mean weight at Baseline in the Second Treatment Phase. |
| Percentage of Responders Assessed by the HDSS in the Second Treatment Phase | Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase | The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. A responder was defined as a participant whose change from Baseline (Week 0 in the Second Treatment Phase) was equal to or less than -2. |
| Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase | Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase | The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. Change from Baseline in HDSS was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase | The DLQI is a dermatology-specific, participant-answered questionnaire that allows for comparison of Quality of Life (QOL). DLQI total score (0-30) is a sum of the scores of 6 domains: Symptoms and Feelings, Daily Activities, Leisure, and Personal Relationships (score=0-6 for each); Work and School, and Treatment (score=0-3 for both; 0=not at all or not applicable, 3=very much or yes only in one item of Work and School). A lower score indicates better condition. Change from Baseline in the DLQI total score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Symptoms and Feelings domain consists of 2 questions (Item 1 and Item 2). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Symptoms and Feelings domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Daily Activities domain consists of 2 questions (Item 3 and Item 4). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Daily Activities domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Leisure domain consists of 2 questions (Item 5 and Item 6). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Leisure domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Work and School domain consists of 1 question (Item 7). The score for this item ranges from 0 (not at all or not applicable) to 3 (yes); therefore, the possible total score for the Work and School domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Personal Relationships domain consists of 2 questions (Item 8 and Item 9). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Personal Relationships domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Treatment domain consists of 1 question (Item 10). The score for this item ranges from 0 (not at all or not applicable) to 3 (very much); therefore, the total possible score for the Treatment domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 1, participants were asked how itchy, sore, painful or stinging their skin was over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 1 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 2, participants were asked how embarrassed or self conscious they were because of their skin over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 2 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 3, participants were asked how much their skin interfered with them going shopping or looking after their home or garden over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 3 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 4, participants were asked how much their skin interfered with the clothes they wore over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 4 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 5, participants were asked how much their skin affected any social or leisure activities over the last week. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 5 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 6, participants were asked how much their skin made it difficult to do any sports over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 6 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline. |
| Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase | Weeks 1, 8 ,12, 16, 20, and 24 | A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating. |
| Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 8, participants were asked how much their skin created problems with their partner or any of their close friends or relatives over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 8 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 9, participants were asked how much their skin caused any sexual difficulties over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 9 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline. |
| Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 10, participants were asked how much of a problem the treatment for their skin was, for example, by making their home messy, or by taking up time. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 10 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline. |
| Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | Weeks 4 (Study Week 20 to Week 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase | Participant's global assessment of treatment satisfaction is a method used to evaluate a participant's treatment satisfaction. Participants rated any improvement or worsening of their symptoms compared to Baseline by using the following 9-point scale: +4, Complete abolishment of signs and symptoms; +3, Marked improvement; +2, Moderate improvement; +1, Slight improvement; 0, Unchanged; -1, Slight worsening; -2, Moderate worsening; -3, Marked worsening; and -4, Very marked worsening. |
| Duration of Effect | Up to Week 40 | Duration of effect is defined as the number of days between the date of first treatment and the date of the first recording of \>50% production in gravimetric assessment compared to Baseline. |
| Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase | The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 7, participants were asked if their skin prevented them from working or studying over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (yes). Item 7 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline. |
Countries
Japan
Participant flow
Pre-assignment details
This study consisted of a Screening Phase (1- to 2-week period), the First Treatment Phase (16- to 40-week period after first treatment), and the open-label Second Treatment Phase (16- to 24-week period after reinjection). All participants were observed until Week 40 after the first treatment irrespective of whether they received reinjection or not
Participants by arm
| Arm | Count |
|---|---|
| BTX 50 U in First and Second TPs Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase. | 78 |
| Placebo in First TP; BTX 50 U in Second TP Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase. | 74 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Treatment Phase (TP) | Lost to Follow-up | 1 | 0 |
| First Treatment Phase (TP) | Withdrawal by Subject | 3 | 1 |
| Second TP | Lost to Follow-up | 0 | 1 |
| Second TP | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | BTX 50 U in First and Second TPs | Placebo in First TP; BTX 50 U in Second TP | Total |
|---|---|---|---|
| Age, Continuous | 36.2 Years STANDARD_DEVIATION 10.05 | 34.7 Years STANDARD_DEVIATION 11.69 | 35.5 Years STANDARD_DEVIATION 10.87 |
| Race/Ethnicity, Customized Asian-Japanese Heritage | 78 participants | 74 participants | 152 participants |
| Sex: Female, Male Female | 61 Participants | 55 Participants | 116 Participants |
| Sex: Female, Male Male | 17 Participants | 19 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 23 / 144 | 9 / 74 |
| serious Total, serious adverse events | 1 / 144 | 1 / 74 |
Outcome results
Primary
Percentage of Responders Assessed by Gravimetric Measurement at Week 4 in the First Treatment Phase
A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating.
Time frame: Week 4
Population: Full Analysis Set for the First Treatment Phase (FAS1): all participants who received the first treatment of investigational product (IP) and had at least 1 post-Baseline efficacy assessment. The analysis was performed using the Last Observation Carried Forward (LOCF) dataset; missing data were imputed by carrying forward the last available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by Gravimetric Measurement at Week 4 in the First Treatment Phase | 96.2 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by Gravimetric Measurement at Week 4 in the First Treatment Phase | 45.9 percentage of participants |
p-value: <0.00195% CI: [38.1, 62.3]Fisher Exact
Secondary
Duration of Effect
Duration of effect is defined as the number of days between the date of first treatment and the date of the first recording of \>50% production in gravimetric assessment compared to Baseline.
Time frame: Up to Week 40
Population: FAS1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BTX 50 U in First and Second TPs | Duration of Effect | 273.0 days |
| Placebo in First TP; BTX 50 U in Second TP | Duration of Effect | 35.0 days |
Secondary
Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. Change from Baseline in HDSS was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -1.7 scores on a scale | Standard Deviation 0.75 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -1.6 scores on a scale | Standard Deviation 0.72 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -1.6 scores on a scale | Standard Deviation 0.8 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -1.6 scores on a scale | Standard Deviation 0.78 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -1.6 scores on a scale | Standard Deviation 0.77 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -1.7 scores on a scale | Standard Deviation 0.55 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -1.1 scores on a scale | Standard Deviation 0.84 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -1.6 scores on a scale | Standard Deviation 0.63 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -1.6 scores on a scale | Standard Deviation 0.75 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -1.6 scores on a scale | Standard Deviation 0.63 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -1.5 scores on a scale | Standard Deviation 0.64 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -1.6 scores on a scale | Standard Deviation 0.79 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -1.6 scores on a scale | Standard Deviation 0.79 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.5 scores on a scale | Standard Deviation 0.71 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.5 scores on a scale | Standard Deviation 0.84 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.5 scores on a scale | Standard Deviation 0.77 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.7 scores on a scale | Standard Deviation 0.8 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.6 scores on a scale | Standard Deviation 0.71 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -1.0 scores on a scale | Standard Deviation 0.78 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -1.1 scores on a scale | Standard Deviation 0.88 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -1.5 scores on a scale | Standard Deviation 0.55 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in HDSS at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -1.6 scores on a scale | Standard Deviation 0.79 |
Secondary
Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Daily Activities domain consists of 2 questions (Item 3 and Item 4). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Daily Activities domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -2.3 scores on a scale | Standard Deviation 1.56 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -2.4 scores on a scale | Standard Deviation 1.63 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -2.5 scores on a scale | Standard Deviation 1.69 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -2.4 scores on a scale | Standard Deviation 1.63 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -2.4 scores on a scale | Standard Deviation 1.74 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -2.4 scores on a scale | Standard Deviation 1.66 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -1.8 scores on a scale | Standard Deviation 1.76 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -2.4 scores on a scale | Standard Deviation 1.77 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -2.4 scores on a scale | Standard Deviation 1.68 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -2.1 scores on a scale | Standard Deviation 1.76 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -2.2 scores on a scale | Standard Deviation 1.67 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -1.6 scores on a scale | Standard Deviation 1.62 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.5 scores on a scale | Standard Deviation 1.33 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -1.1 scores on a scale | Standard Deviation 1.35 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -1.2 scores on a scale | Standard Deviation 1.57 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -1.5 scores on a scale | Standard Deviation 1.52 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.6 scores on a scale | Standard Deviation 1.4 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.6 scores on a scale | Standard Deviation 1.44 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.9 scores on a scale | Standard Deviation 1.45 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -1.0 scores on a scale | Standard Deviation 1.38 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -1.4 scores on a scale | Standard Deviation 1.62 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -1.3 scores on a scale | Standard Deviation 1.38 |
Secondary
Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Daily Activities domain consists of 2 questions (Item 3 and Item 4). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Daily Activities domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -1.1 scores on a scale | Standard Deviation 1.07 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.8 scores on a scale | Standard Deviation 1.06 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.6 scores on a scale | Standard Deviation 1.07 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.6 scores on a scale | Standard Deviation 1.07 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.9 scores on a scale | Standard Deviation 1.08 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.4 scores on a scale | Standard Deviation 0.82 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -1.4 scores on a scale | Standard Deviation 1.34 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -1.0 scores on a scale | Standard Deviation 1.33 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -1.2 scores on a scale | Standard Deviation 1.39 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -1.3 scores on a scale | Standard Deviation 1.36 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -1.3 scores on a scale | Standard Deviation 1.2 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -1.1 scores on a scale | Standard Deviation 1.48 |
| Total | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -1.2 scores on a scale | Standard Deviation 1.17 |
| Total | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -1.3 scores on a scale | Standard Deviation 1.26 |
| Total | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -1.0 scores on a scale | Standard Deviation 1.42 |
| Total | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -1.2 scores on a scale | Standard Deviation 1.28 |
| Total | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -1.0 scores on a scale | Standard Deviation 1.31 |
| Total | Mean Change From Baseline in the Daily Activities Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.9 scores on a scale | Standard Deviation 1.25 |
Secondary
Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase
The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. Change from Baseline in HDSS was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.9 scores on a scale | Standard Deviation 0.65 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.3 scores on a scale | Standard Deviation 0.67 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.9 scores on a scale | Standard Deviation 0.61 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.8 scores on a scale | Standard Deviation 0.64 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.6 scores on a scale | Standard Deviation 0.54 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.6 scores on a scale | Standard Deviation 0.51 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -1.3 scores on a scale | Standard Deviation 0.8 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -1.2 scores on a scale | Standard Deviation 0.79 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -1.4 scores on a scale | Standard Deviation 0.7 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -1.4 scores on a scale | Standard Deviation 0.75 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -1.1 scores on a scale | Standard Deviation 0.84 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -1.5 scores on a scale | Standard Deviation 0.79 |
| Total | Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.9 scores on a scale | Standard Deviation 0.86 |
| Total | Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -1.2 scores on a scale | Standard Deviation 0.72 |
| Total | Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -1.2 scores on a scale | Standard Deviation 0.77 |
| Total | Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -1.1 scores on a scale | Standard Deviation 0.78 |
| Total | Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -1.0 scores on a scale | Standard Deviation 0.77 |
| Total | Mean Change From Baseline in the HDSS at Weeks 4, 8, 12, 16, 20 and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -1.3 scores on a scale | Standard Deviation 0.79 |
Secondary
Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 10, participants were asked how much of a problem the treatment for their skin was, for example, by making their home messy, or by taking up time. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 10 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.4 scores on a scale | Standard Deviation 0.69 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.4 scores on a scale | Standard Deviation 0.63 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.4 scores on a scale | Standard Deviation 0.69 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.3 scores on a scale | Standard Deviation 0.69 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.4 scores on a scale | Standard Deviation 0.62 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -0.3 scores on a scale | Standard Deviation 0.64 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.3 scores on a scale | Standard Deviation 0.56 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.3 scores on a scale | Standard Deviation 0.57 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.3 scores on a scale | Standard Deviation 0.65 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.3 scores on a scale | Standard Deviation 0.64 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.4 scores on a scale | Standard Deviation 0.66 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.1 scores on a scale | Standard Deviation 0.38 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.1 scores on a scale | Standard Deviation 0.38 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.1 scores on a scale | Standard Deviation 0.48 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.1 scores on a scale | Standard Deviation 0.71 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.2 scores on a scale | Standard Deviation 0.62 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.1 scores on a scale | Standard Deviation 0.65 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.1 scores on a scale | Standard Deviation 0.63 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.1 scores on a scale | Standard Deviation 0.61 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.2 scores on a scale | Standard Deviation 0.56 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.3 scores on a scale | Standard Deviation 0.49 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -0.2 scores on a scale | Standard Deviation 0.41 |
Secondary
Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 10, participants were asked how much of a problem the treatment for their skin was, for example, by making their home messy, or by taking up time. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 10 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.1 scores on a scale | Standard Deviation 0.5 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | 0.0 scores on a scale | Standard Deviation 0.3 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.1 scores on a scale | Standard Deviation 0.36 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.1 scores on a scale | Standard Deviation 0.29 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.1 scores on a scale | Standard Deviation 0.31 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | 0.1 scores on a scale | Standard Deviation 0.32 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.3 scores on a scale | Standard Deviation 0.59 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.3 scores on a scale | Standard Deviation 0.6 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.2 scores on a scale | Standard Deviation 0.69 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.3 scores on a scale | Standard Deviation 0.62 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.2 scores on a scale | Standard Deviation 0.73 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.2 scores on a scale | Standard Deviation 0.73 |
| Total | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.1 scores on a scale | Standard Deviation 0.68 |
| Total | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.2 scores on a scale | Standard Deviation 0.62 |
| Total | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.2 scores on a scale | Standard Deviation 0.61 |
| Total | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.2 scores on a scale | Standard Deviation 0.52 |
| Total | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.2 scores on a scale | Standard Deviation 0.55 |
| Total | Mean Change From Baseline in the Item 10 (Problem Caused by Skin Treatment) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.2 scores on a scale | Standard Deviation 0.56 |
Secondary
Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 1, participants were asked how itchy, sore, painful or stinging their skin was over the last week. The scores for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 1 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.1 scores on a scale | Standard Deviation 0.42 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | 0.0 scores on a scale | Standard Deviation 0.42 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.1 scores on a scale | Standard Deviation 0.48 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | 0.0 scores on a scale | Standard Deviation 0.31 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.1 scores on a scale | Standard Deviation 0.4 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.1 scores on a scale | Standard Deviation 0.22 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.1 scores on a scale | Standard Deviation 0.33 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | 0.0 scores on a scale | Standard Deviation 0.27 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.1 scores on a scale | Standard Deviation 0.51 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.1 scores on a scale | Standard Deviation 0.32 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | 0.0 scores on a scale | Standard Deviation 0.47 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | 0.0 scores on a scale | Standard Deviation 0 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | 0.0 scores on a scale | Standard Deviation 0.39 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | 0.0 scores on a scale | Standard Deviation 0.33 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | 0.0 scores on a scale | Standard Deviation 0.46 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.1 scores on a scale | Standard Deviation 0.4 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | 0.0 scores on a scale | Standard Deviation 0.39 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | 0.2 scores on a scale | Standard Deviation 0.38 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | 0.1 scores on a scale | Standard Deviation 0.26 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | 0.0 scores on a scale | Standard Deviation 0 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | 0.0 scores on a scale | Standard Deviation 0 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | 0.0 scores on a scale | Standard Deviation 0 |
Secondary
Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 1, participants were asked how itchy, sore, painful or stinging their skin was over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 1 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.1 scores on a scale | Standard Deviation 0.51 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.1 scores on a scale | Standard Deviation 0.56 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | 0.1 scores on a scale | Standard Deviation 0.57 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.1 scores on a scale | Standard Deviation 0.55 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.1 scores on a scale | Standard Deviation 0.56 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.1 scores on a scale | Standard Deviation 0.5 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.1 scores on a scale | Standard Deviation 0.3 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.1 scores on a scale | Standard Deviation 0.32 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.1 scores on a scale | Standard Deviation 0.31 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | 0.0 scores on a scale | Standard Deviation 0.38 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | 0.0 scores on a scale | Standard Deviation 0.4 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.1 scores on a scale | Standard Deviation 0.35 |
| Total | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.1 scores on a scale | Standard Deviation 0.37 |
| Total | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.1 scores on a scale | Standard Deviation 0.44 |
| Total | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.1 scores on a scale | Standard Deviation 0.38 |
| Total | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.1 scores on a scale | Standard Deviation 0.4 |
| Total | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.1 scores on a scale | Standard Deviation 0.43 |
| Total | Mean Change From Baseline in the Item 1 (Itchy, Sore, Painful, or Stinging) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.1 scores on a scale | Standard Deviation 0.45 |
Secondary
Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 2, participants were asked how embarrassed or self conscious they were because of their skin over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 2 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.9 scores on a scale | Standard Deviation 0.94 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -1.2 scores on a scale | Standard Deviation 1.02 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -1.2 scores on a scale | Standard Deviation 1.05 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -1.3 scores on a scale | Standard Deviation 1.06 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -1.2 scores on a scale | Standard Deviation 0.97 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -1.4 scores on a scale | Standard Deviation 1.04 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -1.2 scores on a scale | Standard Deviation 1.02 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -1.4 scores on a scale | Standard Deviation 1 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -1.3 scores on a scale | Standard Deviation 1.01 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -1.1 scores on a scale | Standard Deviation 1 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -1.2 scores on a scale | Standard Deviation 0.96 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.9 scores on a scale | Standard Deviation 1.21 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.2 scores on a scale | Standard Deviation 0.92 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.2 scores on a scale | Standard Deviation 0.87 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.3 scores on a scale | Standard Deviation 0.85 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.3 scores on a scale | Standard Deviation 0.91 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.3 scores on a scale | Standard Deviation 0.94 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.6 scores on a scale | Standard Deviation 0.92 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.7 scores on a scale | Standard Deviation 0.98 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -1.2 scores on a scale | Standard Deviation 0.98 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.7 scores on a scale | Standard Deviation 1.5 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 2 (Embarrassed or Self-Conscious) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.7 scores on a scale | Standard Deviation 1.5 |
Secondary
Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 2, participants were asked how embarrassed or self conscious they were because of their skin over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 2 is in the Symptoms and Feelings domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.5 scores on a scale | Standard Deviation 0.71 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.4 scores on a scale | Standard Deviation 0.66 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.3 scores on a scale | Standard Deviation 0.84 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.3 scores on a scale | Standard Deviation 0.67 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.3 scores on a scale | Standard Deviation 0.44 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.2 scores on a scale | Standard Deviation 0.63 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.7 scores on a scale | Standard Deviation 0.85 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.8 scores on a scale | Standard Deviation 0.81 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.7 scores on a scale | Standard Deviation 0.83 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.7 scores on a scale | Standard Deviation 0.81 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.8 scores on a scale | Standard Deviation 0.79 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.7 scores on a scale | Standard Deviation 0.76 |
| Total | Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.6 scores on a scale | Standard Deviation 0.76 |
| Total | Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.6 scores on a scale | Standard Deviation 0.81 |
| Total | Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.6 scores on a scale | Standard Deviation 0.83 |
| Total | Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.5 scores on a scale | Standard Deviation 0.79 |
| Total | Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.7 scores on a scale | Standard Deviation 0.78 |
| Total | Mean Change From Baseline in the Item 2 (Embarrassed or Self-conscious) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.6 scores on a scale | Standard Deviation 0.75 |
Secondary
Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 3, participants were asked how much their skin interfered with them going shopping or looking after their home or garden over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 3 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.9 scores on a scale | Standard Deviation 0.97 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.8 scores on a scale | Standard Deviation 1.03 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -0.9 scores on a scale | Standard Deviation 0.92 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.8 scores on a scale | Standard Deviation 0.96 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.6 scores on a scale | Standard Deviation 1.01 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.8 scores on a scale | Standard Deviation 1.05 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.8 scores on a scale | Standard Deviation 0.97 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.9 scores on a scale | Standard Deviation 0.97 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.8 scores on a scale | Standard Deviation 1.02 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.8 scores on a scale | Standard Deviation 1.04 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.8 scores on a scale | Standard Deviation 0.98 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.6 scores on a scale | Standard Deviation 0.79 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.4 scores on a scale | Standard Deviation 0.89 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.4 scores on a scale | Standard Deviation 0.86 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -0.5 scores on a scale | Standard Deviation 0.84 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.6 scores on a scale | Standard Deviation 0.79 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.2 scores on a scale | Standard Deviation 0.77 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.2 scores on a scale | Standard Deviation 0.76 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.2 scores on a scale | Standard Deviation 0.75 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.3 scores on a scale | Standard Deviation 0.75 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.4 scores on a scale | Standard Deviation 0.91 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.6 scores on a scale | Standard Deviation 0.79 |
Secondary
Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 3, participants were asked how much their skin interfered with them going shopping or looking after their home or garden over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 3 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.2 scores on a scale | Standard Deviation 0.41 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.3 scores on a scale | Standard Deviation 0.57 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.4 scores on a scale | Standard Deviation 0.52 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.3 scores on a scale | Standard Deviation 0.47 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.3 scores on a scale | Standard Deviation 0.51 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.3 scores on a scale | Standard Deviation 0.51 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.3 scores on a scale | Standard Deviation 0.49 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.3 scores on a scale | Standard Deviation 0.57 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.3 scores on a scale | Standard Deviation 0.65 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.3 scores on a scale | Standard Deviation 0.6 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.3 scores on a scale | Standard Deviation 0.59 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.4 scores on a scale | Standard Deviation 0.6 |
| Total | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.3 scores on a scale | Standard Deviation 0.59 |
| Total | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.3 scores on a scale | Standard Deviation 0.55 |
| Total | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.3 scores on a scale | Standard Deviation 0.6 |
| Total | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.4 scores on a scale | Standard Deviation 0.56 |
| Total | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.3 scores on a scale | Standard Deviation 0.58 |
| Total | Mean Change From Baseline in the Item 3 (Interfere Shopping/Caring for Home) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.3 scores on a scale | Standard Deviation 0.5 |
Secondary
Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 4, participants were asked how much their skin interfered with the clothes they wore over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 4 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -1.6 scores on a scale | Standard Deviation 1.02 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -1.5 scores on a scale | Standard Deviation 0.91 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -1.6 scores on a scale | Standard Deviation 1 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -1.6 scores on a scale | Standard Deviation 1.06 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -1.6 scores on a scale | Standard Deviation 0.97 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -1.5 scores on a scale | Standard Deviation 0.96 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -1.5 scores on a scale | Standard Deviation 0.92 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -1.5 scores on a scale | Standard Deviation 1 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -1.5 scores on a scale | Standard Deviation 0.87 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -1.3 scores on a scale | Standard Deviation 0.94 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -1.2 scores on a scale | Standard Deviation 1.03 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -1.0 scores on a scale | Standard Deviation 1.15 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.5 scores on a scale | Standard Deviation 0.88 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.3 scores on a scale | Standard Deviation 0.9 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.4 scores on a scale | Standard Deviation 1.01 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.5 scores on a scale | Standard Deviation 0.9 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.6 scores on a scale | Standard Deviation 0.91 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.8 scores on a scale | Standard Deviation 0.78 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.8 scores on a scale | Standard Deviation 1.08 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -1.0 scores on a scale | Standard Deviation 0.89 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.9 scores on a scale | Standard Deviation 1.21 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.7 scores on a scale | Standard Deviation 1.11 |
Secondary
Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 4, participants were asked how much their skin interfered with the clothes they wore over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 4 is in the Daily Activities domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.7 scores on a scale | Standard Deviation 0.71 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.2 scores on a scale | Standard Deviation 0.52 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.6 scores on a scale | Standard Deviation 0.66 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.4 scores on a scale | Standard Deviation 0.7 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.2 scores on a scale | Standard Deviation 0.63 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.6 scores on a scale | Standard Deviation 0.69 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -1.0 scores on a scale | Standard Deviation 0.89 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.9 scores on a scale | Standard Deviation 1.03 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -1.0 scores on a scale | Standard Deviation 0.93 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -1.0 scores on a scale | Standard Deviation 0.93 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.8 scores on a scale | Standard Deviation 0.94 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.8 scores on a scale | Standard Deviation 1.08 |
| Total | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.8 scores on a scale | Standard Deviation 0.86 |
| Total | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.7 scores on a scale | Standard Deviation 1.04 |
| Total | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.6 scores on a scale | Standard Deviation 0.88 |
| Total | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.9 scores on a scale | Standard Deviation 0.87 |
| Total | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.9 scores on a scale | Standard Deviation 0.85 |
| Total | Mean Change From Baseline in the Item 4 (Influenced Clothes You Wear) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.7 scores on a scale | Standard Deviation 0.96 |
Secondary
Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 5, participants were asked how much their skin affected any social or leisure activities over the last week. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 5 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.8 scores on a scale | Standard Deviation 0.94 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -1.1 scores on a scale | Standard Deviation 0.97 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -1.0 scores on a scale | Standard Deviation 0.92 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -1.1 scores on a scale | Standard Deviation 0.98 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -1.0 scores on a scale | Standard Deviation 0.94 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -1.1 scores on a scale | Standard Deviation 1.02 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -1.0 scores on a scale | Standard Deviation 0.95 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -1.0 scores on a scale | Standard Deviation 1.02 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.9 scores on a scale | Standard Deviation 0.92 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -1.1 scores on a scale | Standard Deviation 0.99 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -1.0 scores on a scale | Standard Deviation 0.93 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.4 scores on a scale | Standard Deviation 0.98 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.2 scores on a scale | Standard Deviation 0.8 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.3 scores on a scale | Standard Deviation 0.82 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.4 scores on a scale | Standard Deviation 0.84 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.4 scores on a scale | Standard Deviation 0.86 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.3 scores on a scale | Standard Deviation 0.75 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.1 scores on a scale | Standard Deviation 0.7 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -0.5 scores on a scale | Standard Deviation 0.84 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.4 scores on a scale | Standard Deviation 1.51 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.4 scores on a scale | Standard Deviation 0.98 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.3 scores on a scale | Standard Deviation 0.86 |
Secondary
Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 5, participants were asked how much their skin affected any social or leisure activities over the last week. The Score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 5 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | 0.0 scores on a scale | Standard Deviation 0 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.3 scores on a scale | Standard Deviation 0.57 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.3 scores on a scale | Standard Deviation 0.62 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.3 scores on a scale | Standard Deviation 0.59 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.2 scores on a scale | Standard Deviation 0.37 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.2 scores on a scale | Standard Deviation 0.7 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.3 scores on a scale | Standard Deviation 0.75 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.3 scores on a scale | Standard Deviation 0.67 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.4 scores on a scale | Standard Deviation 0.71 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.4 scores on a scale | Standard Deviation 0.68 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.4 scores on a scale | Standard Deviation 0.69 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.4 scores on a scale | Standard Deviation 0.66 |
| Total | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.3 scores on a scale | Standard Deviation 0.69 |
| Total | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.3 scores on a scale | Standard Deviation 0.65 |
| Total | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.4 scores on a scale | Standard Deviation 0.63 |
| Total | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.3 scores on a scale | Standard Deviation 0.61 |
| Total | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.3 scores on a scale | Standard Deviation 0.66 |
| Total | Mean Change From Baseline in the Item 5 (Affected Social/Leisure Activities) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.4 scores on a scale | Standard Deviation 0.71 |
Secondary
Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 6, participants were asked how much their skin made it difficult to do any sports over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 6 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.7 scores on a scale | Standard Deviation 0.94 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.7 scores on a scale | Standard Deviation 0.94 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.6 scores on a scale | Standard Deviation 0.94 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.7 scores on a scale | Standard Deviation 1 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.7 scores on a scale | Standard Deviation 0.91 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.7 scores on a scale | Standard Deviation 0.94 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.7 scores on a scale | Standard Deviation 0.94 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -0.7 scores on a scale | Standard Deviation 0.87 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.7 scores on a scale | Standard Deviation 0.92 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.7 scores on a scale | Standard Deviation 0.99 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.7 scores on a scale | Standard Deviation 0.94 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -0.8 scores on a scale | Standard Deviation 0.98 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.4 scores on a scale | Standard Deviation 0.9 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.7 scores on a scale | Standard Deviation 1.16 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.7 scores on a scale | Standard Deviation 1.38 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.6 scores on a scale | Standard Deviation 1.13 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.3 scores on a scale | Standard Deviation 0.85 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.7 scores on a scale | Standard Deviation 1.1 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.3 scores on a scale | Standard Deviation 0.85 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.7 scores on a scale | Standard Deviation 0.95 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.4 scores on a scale | Standard Deviation 0.86 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.4 scores on a scale | Standard Deviation 0.91 |
Secondary
Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 6, participants were asked how much their skin made it difficult to do any sports over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 6 is in the Leisure domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.2 scores on a scale | Standard Deviation 0.63 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.2 scores on a scale | Standard Deviation 0.46 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.2 scores on a scale | Standard Deviation 0.37 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.3 scores on a scale | Standard Deviation 0.45 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.2 scores on a scale | Standard Deviation 0.48 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.2 scores on a scale | Standard Deviation 0.52 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.3 scores on a scale | Standard Deviation 0.57 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.2 scores on a scale | Standard Deviation 0.54 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.3 scores on a scale | Standard Deviation 0.56 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.3 scores on a scale | Standard Deviation 0.53 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.3 scores on a scale | Standard Deviation 0.6 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.3 scores on a scale | Standard Deviation 0.54 |
| Total | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.2 scores on a scale | Standard Deviation 0.55 |
| Total | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.3 scores on a scale | Standard Deviation 0.55 |
| Total | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.2 scores on a scale | Standard Deviation 0.55 |
| Total | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.2 scores on a scale | Standard Deviation 0.54 |
| Total | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.3 scores on a scale | Standard Deviation 0.49 |
| Total | Mean Change From Baseline in the Item 6 (Difficult to Do Any Sport) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.3 scores on a scale | Standard Deviation 0.51 |
Secondary
Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 7, participants were asked if their skin prevented them from working or studying over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (yes). Item 7 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Population: FAS1 The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -0.8 scores on a scale | Standard Deviation 0.73 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.6 scores on a scale | Standard Deviation 0.78 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.7 scores on a scale | Standard Deviation 0.75 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.7 scores on a scale | Standard Deviation 0.73 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.8 scores on a scale | Standard Deviation 0.82 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.7 scores on a scale | Standard Deviation 0.79 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.8 scores on a scale | Standard Deviation 0.66 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.5 scores on a scale | Standard Deviation 0.64 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.7 scores on a scale | Standard Deviation 0.79 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.7 scores on a scale | Standard Deviation 0.65 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.7 scores on a scale | Standard Deviation 0.78 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.6 scores on a scale | Standard Deviation 0.53 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -0.5 scores on a scale | Standard Deviation 0.55 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.2 scores on a scale | Standard Deviation 0.57 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.1 scores on a scale | Standard Deviation 0.76 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.1 scores on a scale | Standard Deviation 0.69 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.2 scores on a scale | Standard Deviation 0.74 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.1 scores on a scale | Standard Deviation 0.71 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.3 scores on a scale | Standard Deviation 0.82 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.2 scores on a scale | Standard Deviation 0.86 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.1 scores on a scale | Standard Deviation 1.46 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.4 scores on a scale | Standard Deviation 0.79 |
Secondary
Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 7, participants were asked if their skin prevented them from working or studying over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (yes). Item 7 is in the Work and School domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.3 scores on a scale | Standard Deviation 0.51 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.2 scores on a scale | Standard Deviation 0.65 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.1 scores on a scale | Standard Deviation 0.57 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.2 scores on a scale | Standard Deviation 0.43 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.1 scores on a scale | Standard Deviation 0.56 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.2 scores on a scale | Standard Deviation 0.37 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.5 scores on a scale | Standard Deviation 0.93 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.4 scores on a scale | Standard Deviation 0.78 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.4 scores on a scale | Standard Deviation 0.91 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.6 scores on a scale | Standard Deviation 0.83 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.5 scores on a scale | Standard Deviation 0.84 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.5 scores on a scale | Standard Deviation 0.85 |
| Total | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.4 scores on a scale | Standard Deviation 0.87 |
| Total | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.4 scores on a scale | Standard Deviation 0.74 |
| Total | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.5 scores on a scale | Standard Deviation 0.75 |
| Total | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.4 scores on a scale | Standard Deviation 0.8 |
| Total | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.4 scores on a scale | Standard Deviation 0.71 |
| Total | Mean Change From Baseline in the Item 7 (Problem at Work or Studying) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.4 scores on a scale | Standard Deviation 0.83 |
Secondary
Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 8, participants were asked how much their skin created problems with their partner or any of their close friends or relatives over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 8 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.3 scores on a scale | Standard Deviation 0.54 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.3 scores on a scale | Standard Deviation 0.53 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.3 scores on a scale | Standard Deviation 0.54 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -0.3 scores on a scale | Standard Deviation 0.5 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.3 scores on a scale | Standard Deviation 0.54 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.3 scores on a scale | Standard Deviation 0.51 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.3 scores on a scale | Standard Deviation 0.58 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.2 scores on a scale | Standard Deviation 0.49 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.3 scores on a scale | Standard Deviation 0.52 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.3 scores on a scale | Standard Deviation 0.51 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.3 scores on a scale | Standard Deviation 0.57 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.1 scores on a scale | Standard Deviation 0.38 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.1 scores on a scale | Standard Deviation 0.42 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.1 scores on a scale | Standard Deviation 0.45 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.1 scores on a scale | Standard Deviation 0.51 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.1 scores on a scale | Standard Deviation 0.55 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.1 scores on a scale | Standard Deviation 0.6 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.1 scores on a scale | Standard Deviation 0.41 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.1 scores on a scale | Standard Deviation 0.46 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -0.2 scores on a scale | Standard Deviation 0.41 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.1 scores on a scale | Standard Deviation 0.38 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.1 scores on a scale | Standard Deviation 0.38 |
Secondary
Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 8, participants were asked how much their skin created problems with their partner or any of their close friends or relatives over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 8 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | 0.0 scores on a scale | Standard Deviation 0 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | 0.0 scores on a scale | Standard Deviation 0.17 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | 0.0 scores on a scale | Standard Deviation 0.17 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | 0.1 scores on a scale | Standard Deviation 0.22 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | 0.2 scores on a scale | Standard Deviation 0.63 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | 0.0 scores on a scale | Standard Deviation 0.17 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.1 scores on a scale | Standard Deviation 0.58 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.2 scores on a scale | Standard Deviation 0.49 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.2 scores on a scale | Standard Deviation 0.51 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.2 scores on a scale | Standard Deviation 0.41 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.2 scores on a scale | Standard Deviation 0.52 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.1 scores on a scale | Standard Deviation 0.41 |
| Total | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.1 scores on a scale | Standard Deviation 0.4 |
| Total | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.1 scores on a scale | Standard Deviation 0.44 |
| Total | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.1 scores on a scale | Standard Deviation 0.6 |
| Total | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.1 scores on a scale | Standard Deviation 0.38 |
| Total | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.1 scores on a scale | Standard Deviation 0.45 |
| Total | Mean Change From Baseline in the Item 8 (Problem With Partner/Friends) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.1 scores on a scale | Standard Deviation 0.43 |
Secondary
Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 9, participants were asked how much their skin caused any sexual difficulties over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 9 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.1 scores on a scale | Standard Deviation 0.39 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.1 scores on a scale | Standard Deviation 0.41 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.1 scores on a scale | Standard Deviation 0.42 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 28, n=42, 6 | -0.1 scores on a scale | Standard Deviation 0.4 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.1 scores on a scale | Standard Deviation 0.47 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.1 scores on a scale | Standard Deviation 0.4 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.1 scores on a scale | Standard Deviation 0.39 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.1 scores on a scale | Standard Deviation 0.4 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.1 scores on a scale | Standard Deviation 0.39 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.1 scores on a scale | Standard Deviation 0.4 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.2 scores on a scale | Standard Deviation 0.4 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.1 scores on a scale | Standard Deviation 0.38 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 1, n=78, 74 | 0.0 scores on a scale | Standard Deviation 0.31 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.1 scores on a scale | Standard Deviation 0.33 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.1 scores on a scale | Standard Deviation 0.33 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.1 scores on a scale | Standard Deviation 0.4 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 16, n=76, 73 | 0.0 scores on a scale | Standard Deviation 0.37 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 20, n=65, 24 | 0.0 scores on a scale | Standard Deviation 0.36 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 24, n=56, 15 | 0.0 scores on a scale | Standard Deviation 0.38 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 28, n=42, 6 | -0.2 scores on a scale | Standard Deviation 0.41 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.1 scores on a scale | Standard Deviation 0.38 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.1 scores on a scale | Standard Deviation 0.38 |
Secondary
Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. In Item 9, participants were asked how much their skin caused any sexual difficulties over the last week. The score for this item ranges from 0 (not at all or not applicable) to 3 (very much). Item 9 is in the Personal Relationships domain. A lower score indicates better condition. Change from Baseline in each item score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.1 scores on a scale | Standard Deviation 0.24 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | 0.0 scores on a scale | Standard Deviation 0 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.1 scores on a scale | Standard Deviation 0.24 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.1 scores on a scale | Standard Deviation 0.29 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.1 scores on a scale | Standard Deviation 0.22 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.1 scores on a scale | Standard Deviation 0.24 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.2 scores on a scale | Standard Deviation 0.49 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.1 scores on a scale | Standard Deviation 0.43 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.2 scores on a scale | Standard Deviation 0.44 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.2 scores on a scale | Standard Deviation 0.5 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.2 scores on a scale | Standard Deviation 0.46 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.1 scores on a scale | Standard Deviation 0.46 |
| Total | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.1 scores on a scale | Standard Deviation 0.43 |
| Total | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.1 scores on a scale | Standard Deviation 0.42 |
| Total | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.1 scores on a scale | Standard Deviation 0.42 |
| Total | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.1 scores on a scale | Standard Deviation 0.39 |
| Total | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.1 scores on a scale | Standard Deviation 0.39 |
| Total | Mean Change From Baseline in the Item 9 (Caused Any Sexual Difficulties) Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.1 scores on a scale | Standard Deviation 0.41 |
Secondary
Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Leisure domain consists of 2 questions (Item 5 and Item 6). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Leisure domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -1.6 scores on a scale | Standard Deviation 1.6 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -1.7 scores on a scale | Standard Deviation 1.56 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -1.7 scores on a scale | Standard Deviation 1.5 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -1.9 scores on a scale | Standard Deviation 1.67 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -1.7 scores on a scale | Standard Deviation 1.76 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -1.8 scores on a scale | Standard Deviation 1.59 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -1.7 scores on a scale | Standard Deviation 1.51 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -1.8 scores on a scale | Standard Deviation 1.72 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -1.4 scores on a scale | Standard Deviation 1.62 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -1.7 scores on a scale | Standard Deviation 1.71 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -1.7 scores on a scale | Standard Deviation 1.52 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -1.0 scores on a scale | Standard Deviation 1.91 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -1.1 scores on a scale | Standard Deviation 2.19 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.6 scores on a scale | Standard Deviation 1.33 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.7 scores on a scale | Standard Deviation 1.38 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.8 scores on a scale | Standard Deviation 1.45 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.7 scores on a scale | Standard Deviation 1.45 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -1.0 scores on a scale | Standard Deviation 1.53 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.8 scores on a scale | Standard Deviation 1.52 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -1.3 scores on a scale | Standard Deviation 1.63 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -1.1 scores on a scale | Standard Deviation 2.19 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.5 scores on a scale | Standard Deviation 1.37 |
Secondary
Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Leisure domain consists of 2 questions (Item 5 and Item 6). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Leisure domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.6 scores on a scale | Standard Deviation 0.82 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.3 scores on a scale | Standard Deviation 0.47 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.4 scores on a scale | Standard Deviation 0.96 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.4 scores on a scale | Standard Deviation 0.82 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.5 scores on a scale | Standard Deviation 0.83 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.2 scores on a scale | Standard Deviation 0.63 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.7 scores on a scale | Standard Deviation 0.97 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.6 scores on a scale | Standard Deviation 1.01 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.7 scores on a scale | Standard Deviation 1.02 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.7 scores on a scale | Standard Deviation 1.03 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.6 scores on a scale | Standard Deviation 0.89 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.5 scores on a scale | Standard Deviation 1.02 |
| Total | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.6 scores on a scale | Standard Deviation 0.92 |
| Total | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.5 scores on a scale | Standard Deviation 0.97 |
| Total | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.6 scores on a scale | Standard Deviation 0.95 |
| Total | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.5 scores on a scale | Standard Deviation 0.81 |
| Total | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.6 scores on a scale | Standard Deviation 1.01 |
| Total | Mean Change From Baseline in the Leisure Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.6 scores on a scale | Standard Deviation 0.96 |
Secondary
Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Personal Relationships domain consists of 2 questions (Item 8 and Item 9). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Personal Relationships domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.4 scores on a scale | Standard Deviation 0.83 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.4 scores on a scale | Standard Deviation 0.88 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.4 scores on a scale | Standard Deviation 0.8 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.4 scores on a scale | Standard Deviation 0.85 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.4 scores on a scale | Standard Deviation 0.83 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 13 | -0.4 scores on a scale | Standard Deviation 0.81 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.4 scores on a scale | Standard Deviation 0.81 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.4 scores on a scale | Standard Deviation 0.8 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -0.4 scores on a scale | Standard Deviation 0.79 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.4 scores on a scale | Standard Deviation 0.81 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.4 scores on a scale | Standard Deviation 0.81 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.3 scores on a scale | Standard Deviation 0.76 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.1 scores on a scale | Standard Deviation 0.74 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.2 scores on a scale | Standard Deviation 0.84 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.3 scores on a scale | Standard Deviation 0.76 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.1 scores on a scale | Standard Deviation 0.7 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.1 scores on a scale | Standard Deviation 0.61 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.3 scores on a scale | Standard Deviation 0.76 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.1 scores on a scale | Standard Deviation 0.64 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.2 scores on a scale | Standard Deviation 0.68 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -0.3 scores on a scale | Standard Deviation 0.82 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 13 | -0.2 scores on a scale | Standard Deviation 0.8 |
Secondary
Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Personal Relationships domain consists of 2 questions (Item 8 and Item 9). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Personal Relationships domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | 0.2 scores on a scale | Standard Deviation 0.63 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | 0.0 scores on a scale | Standard Deviation 0.3 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | 0.0 scores on a scale | Standard Deviation 0.3 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | 0.0 scores on a scale | Standard Deviation 0.3 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.1 scores on a scale | Standard Deviation 0.29 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.1 scores on a scale | Standard Deviation 0.29 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.3 scores on a scale | Standard Deviation 0.78 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.3 scores on a scale | Standard Deviation 0.89 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.3 scores on a scale | Standard Deviation 0.73 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.3 scores on a scale | Standard Deviation 0.77 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.3 scores on a scale | Standard Deviation 0.81 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.3 scores on a scale | Standard Deviation 0.87 |
| Total | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.2 scores on a scale | Standard Deviation 0.65 |
| Total | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.2 scores on a scale | Standard Deviation 0.75 |
| Total | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.2 scores on a scale | Standard Deviation 0.63 |
| Total | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.2 scores on a scale | Standard Deviation 0.66 |
| Total | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.2 scores on a scale | Standard Deviation 0.85 |
| Total | Mean Change From Baseline in the Personal Relationships Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.2 scores on a scale | Standard Deviation 0.69 |
Secondary
Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Symptoms and Feelings domain consists of 2 questions (Item 1 and Item 2). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Symptoms and Feelings domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -1.3 scores on a scale | Standard Deviation 1.04 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=8, 74 | -0.9 scores on a scale | Standard Deviation 0.97 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -1.2 scores on a scale | Standard Deviation 1.01 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -1.3 scores on a scale | Standard Deviation 1.16 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -1.3 scores on a scale | Standard Deviation 0.99 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -1.2 scores on a scale | Standard Deviation 1.07 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -1.3 scores on a scale | Standard Deviation 1.19 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -1.5 scores on a scale | Standard Deviation 1.13 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -1.4 scores on a scale | Standard Deviation 1.08 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -1.3 scores on a scale | Standard Deviation 1.11 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -1.3 scores on a scale | Standard Deviation 1.06 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -1.2 scores on a scale | Standard Deviation 0.98 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.4 scores on a scale | Standard Deviation 0.96 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.7 scores on a scale | Standard Deviation 1.5 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.5 scores on a scale | Standard Deviation 1.06 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=8, 74 | -0.2 scores on a scale | Standard Deviation 0.95 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.7 scores on a scale | Standard Deviation 1.5 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.2 scores on a scale | Standard Deviation 0.9 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.6 scores on a scale | Standard Deviation 1.06 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.3 scores on a scale | Standard Deviation 0.87 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.9 scores on a scale | Standard Deviation 1.21 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.3 scores on a scale | Standard Deviation 1.04 |
Secondary
Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Symptoms and Feelings domain consists of 2 questions (Item 1 and Item 2). Scores range from 0 (not at all or not applicable) to 3 (very much) for each item; therefore, the possible total score for the Symptoms and Feelings domain is 0 to 6. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.6 scores on a scale | Standard Deviation 1.04 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.1 scores on a scale | Standard Deviation 1.1 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.3 scores on a scale | Standard Deviation 0.66 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.5 scores on a scale | Standard Deviation 0.99 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.5 scores on a scale | Standard Deviation 0.9 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.4 scores on a scale | Standard Deviation 0.89 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.8 scores on a scale | Standard Deviation 0.89 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.8 scores on a scale | Standard Deviation 0.84 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.7 scores on a scale | Standard Deviation 0.93 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.8 scores on a scale | Standard Deviation 0.84 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.8 scores on a scale | Standard Deviation 0.85 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.8 scores on a scale | Standard Deviation 0.86 |
| Total | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.7 scores on a scale | Standard Deviation 0.92 |
| Total | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.7 scores on a scale | Standard Deviation 0.91 |
| Total | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.6 scores on a scale | Standard Deviation 0.81 |
| Total | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.7 scores on a scale | Standard Deviation 0.88 |
| Total | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.6 scores on a scale | Standard Deviation 0.92 |
| Total | Mean Change From Baseline in the Symptoms and Feelings Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.8 scores on a scale | Standard Deviation 0.95 |
Secondary
Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
The DLQI is a dermatology-specific, participant-answered questionnaire that allows for comparison of Quality of Life (QOL). DLQI total score (0-30) is a sum of the scores of 6 domains: Symptoms and Feelings, Daily Activities, Leisure, and Personal Relationships (score=0-6 for each); Work and School, and Treatment (score=0-3 for both; 0=not at all or not applicable, 3=very much or yes only in one item of Work and School). A lower score indicates better condition. Change from Baseline in the DLQI total score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -5.4 scores on a scale | Standard Deviation 4.61 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -6.9 scores on a scale | Standard Deviation 4.41 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -7.3 scores on a scale | Standard Deviation 4.66 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -6.9 scores on a scale | Standard Deviation 4.48 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -6.6 scores on a scale | Standard Deviation 4.82 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -6.7 scores on a scale | Standard Deviation 4.34 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -7.1 scores on a scale | Standard Deviation 4.69 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -6.9 scores on a scale | Standard Deviation 4.77 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -6.9 scores on a scale | Standard Deviation 4.72 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -6.5 scores on a scale | Standard Deviation 4.75 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -6.9 scores on a scale | Standard Deviation 4.82 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -4.4 scores on a scale | Standard Deviation 5.19 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -1.7 scores on a scale | Standard Deviation 3.66 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -2.0 scores on a scale | Standard Deviation 3.89 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -3.1 scores on a scale | Standard Deviation 4.53 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -5.0 scores on a scale | Standard Deviation 4.73 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -3.9 scores on a scale | Standard Deviation 6.47 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -2.5 scores on a scale | Standard Deviation 4.26 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -2.5 scores on a scale | Standard Deviation 4.25 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -3.1 scores on a scale | Standard Deviation 4.37 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -4.1 scores on a scale | Standard Deviation 5.7 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -1.8 scores on a scale | Standard Deviation 3.49 |
Secondary
Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
The DLQI is a dermatology-specific, participant-answered questionnaire that allows for comparison of Quality of Life (QOL). DLQI total score (0-30) is a sum of the scores of 6 domains: Symptoms and Feelings, Daily Activities, Leisure, and Personal Relationships (score=0-6 for each); Work and School, and Treatment (score=0-3 for both; 0=not at all or not applicable, 3=very much or yes only in one item of Work and School). A lower score indicates better condition. Change from Baseline in the DLQI total score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -2.6 scores on a scale | Standard Deviation 2.65 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -2.4 scores on a scale | Standard Deviation 3.18 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.7 scores on a scale | Standard Deviation 3.2 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -2.0 scores on a scale | Standard Deviation 2.72 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -1.9 scores on a scale | Standard Deviation 2.48 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -1.3 scores on a scale | Standard Deviation 1.41 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -3.7 scores on a scale | Standard Deviation 4.46 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -3.3 scores on a scale | Standard Deviation 4.03 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -3.9 scores on a scale | Standard Deviation 4.04 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -4.0 scores on a scale | Standard Deviation 4.21 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -3.3 scores on a scale | Standard Deviation 4.55 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -4.0 scores on a scale | Standard Deviation 4.28 |
| Total | Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -2.8 scores on a scale | Standard Deviation 4.43 |
| Total | Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -3.6 scores on a scale | Standard Deviation 3.79 |
| Total | Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -3.2 scores on a scale | Standard Deviation 3.74 |
| Total | Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -3.0 scores on a scale | Standard Deviation 3.96 |
| Total | Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -2.8 scores on a scale | Standard Deviation 3.63 |
| Total | Mean Change From Baseline in the Total Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -3.4 scores on a scale | Standard Deviation 4 |
Secondary
Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Treatment domain consists of 1 question (Item 10). The score for this item ranges from 0 (not at all or not applicable) to 3 (very much); therefore, the total possible score for the Treatment domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.4 scores on a scale | Standard Deviation 0.62 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.3 scores on a scale | Standard Deviation 0.69 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.4 scores on a scale | Standard Deviation 0.69 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -0.3 scores on a scale | Standard Deviation 0.64 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.4 scores on a scale | Standard Deviation 0.66 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.3 scores on a scale | Standard Deviation 0.56 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.4 scores on a scale | Standard Deviation 0.69 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.3 scores on a scale | Standard Deviation 0.57 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.4 scores on a scale | Standard Deviation 0.63 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.3 scores on a scale | Standard Deviation 0.64 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.3 scores on a scale | Standard Deviation 0.65 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.1 scores on a scale | Standard Deviation 0.38 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.1 scores on a scale | Standard Deviation 0.48 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.1 scores on a scale | Standard Deviation 0.71 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.2 scores on a scale | Standard Deviation 0.62 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.1 scores on a scale | Standard Deviation 0.65 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.1 scores on a scale | Standard Deviation 0.63 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.1 scores on a scale | Standard Deviation 0.61 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.2 scores on a scale | Standard Deviation 0.56 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -0.2 scores on a scale | Standard Deviation 0.41 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.1 scores on a scale | Standard Deviation 0.38 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.3 scores on a scale | Standard Deviation 0.49 |
Secondary
Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Treatment domain consists of 1 question (Item 10). The score for this item ranges from 0 (not at all or not applicable) to 3 (very much); therefore, the total possible score for the Treatment domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.1 scores on a scale | Standard Deviation 0.31 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.1 scores on a scale | Standard Deviation 0.36 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | 0.1 scores on a scale | Standard Deviation 0.32 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | 0.0 scores on a scale | Standard Deviation 0.3 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.1 scores on a scale | Standard Deviation 0.29 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.1 scores on a scale | Standard Deviation 0.5 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.3 scores on a scale | Standard Deviation 0.59 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.2 scores on a scale | Standard Deviation 0.69 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.2 scores on a scale | Standard Deviation 0.73 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.3 scores on a scale | Standard Deviation 0.6 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.2 scores on a scale | Standard Deviation 0.73 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.3 scores on a scale | Standard Deviation 0.62 |
| Total | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.1 scores on a scale | Standard Deviation 0.68 |
| Total | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.2 scores on a scale | Standard Deviation 0.56 |
| Total | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.2 scores on a scale | Standard Deviation 0.55 |
| Total | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.2 scores on a scale | Standard Deviation 0.62 |
| Total | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.2 scores on a scale | Standard Deviation 0.61 |
| Total | Mean Change From Baseline in the Treatment Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.2 scores on a scale | Standard Deviation 0.52 |
Secondary
Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Work and School domain consists of 1 question (Item 7). The score for this item ranges from 0 (not at all or not applicable) to 3 (yes); therefore, the possible total score for the Work and School domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.6 scores on a scale | Standard Deviation 0.78 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.7 scores on a scale | Standard Deviation 0.78 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.7 scores on a scale | Standard Deviation 0.75 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -0.8 scores on a scale | Standard Deviation 0.73 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.7 scores on a scale | Standard Deviation 0.79 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.8 scores on a scale | Standard Deviation 0.66 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.7 scores on a scale | Standard Deviation 0.73 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.8 scores on a scale | Standard Deviation 0.82 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.7 scores on a scale | Standard Deviation 0.79 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.7 scores on a scale | Standard Deviation 0.65 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.5 scores on a scale | Standard Deviation 0.64 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 40, n=40, 7 | -0.6 scores on a scale | Standard Deviation 0.53 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 16, n=76, 73 | -0.1 scores on a scale | Standard Deviation 0.71 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 1, n=78, 74 | -0.2 scores on a scale | Standard Deviation 0.57 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 8, n=78, 73 | -0.1 scores on a scale | Standard Deviation 0.69 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 12, n=76, 73 | -0.2 scores on a scale | Standard Deviation 0.74 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 20, n=65, 24 | -0.3 scores on a scale | Standard Deviation 0.82 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 24, n=56, 15 | -0.2 scores on a scale | Standard Deviation 0.86 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 28, n=42, 6 | -0.5 scores on a scale | Standard Deviation 0.55 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 32, n=40, 7 | -0.1 scores on a scale | Standard Deviation 1.46 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 36, n=41, 7 | -0.4 scores on a scale | Standard Deviation 0.79 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 in the First Treatment Phase | Week 4, n=78, 73 | -0.1 scores on a scale | Standard Deviation 0.76 |
Secondary
Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase
The DLQI is a dermatology-specific questionnaire that can be quickly answered by the participants and allows for comparison of QOL. The Work and School domain consists of 1 question (Item 7). The score for this item ranges from 0 (not at all or not applicable) to 3 (yes); therefore, the possible total score for the Work and School domain is 0 to 3. A lower score indicates better condition. Change from Baseline in each domain score was calculated as follows: score at each visit minus score at Baseline.
Time frame: Baseline (Week 0) and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.1 scores on a scale | Standard Deviation 0.56 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.1 scores on a scale | Standard Deviation 0.57 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.2 scores on a scale | Standard Deviation 0.43 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.3 scores on a scale | Standard Deviation 0.51 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.2 scores on a scale | Standard Deviation 0.37 |
| BTX 50 U in First and Second TPs | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.2 scores on a scale | Standard Deviation 0.65 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.6 scores on a scale | Standard Deviation 0.83 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.5 scores on a scale | Standard Deviation 0.85 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.5 scores on a scale | Standard Deviation 0.93 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.5 scores on a scale | Standard Deviation 0.84 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.4 scores on a scale | Standard Deviation 0.78 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.4 scores on a scale | Standard Deviation 0.91 |
| Total | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 4, n=34, 65, 99 | -0.5 scores on a scale | Standard Deviation 0.75 |
| Total | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 24, n=10, 49, 59 | -0.4 scores on a scale | Standard Deviation 0.87 |
| Total | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 20, n=20, 56, 76 | -0.4 scores on a scale | Standard Deviation 0.71 |
| Total | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 12, n=34, 64, 98 | -0.4 scores on a scale | Standard Deviation 0.83 |
| Total | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 8, n=34, 65, 99 | -0.4 scores on a scale | Standard Deviation 0.8 |
| Total | Mean Change From Baseline in the Work and School Domain Score of the DLQI at Weeks 4, 8, 12, 16, 20, and 24 in the Second Treatment Phase | Week 16, n=34, 62, 96 | -0.4 scores on a scale | Standard Deviation 0.74 |
Secondary
Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase
A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. Percent change from Baseline was calculated as follows: (mean weight at each visit minus mean weight at Baseline) \* 100/mean weight at Baseline.
Time frame: Week 0 (Baseline); and Weeks 1, 4, 8, 12, 16, 20, and 24
Population: FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 24 | -55.6 percent change | Standard Deviation 69.41 |
| BTX 50 U in First and Second TPs | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 8 | -84.8 percent change | Standard Deviation 25.07 |
| BTX 50 U in First and Second TPs | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 16 | -78.8 percent change | Standard Deviation 40.39 |
| BTX 50 U in First and Second TPs | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 1 | -82.4 percent change | Standard Deviation 24.4 |
| BTX 50 U in First and Second TPs | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 4 | -87.0 percent change | Standard Deviation 16 |
| BTX 50 U in First and Second TPs | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 12 | -81.0 percent change | Standard Deviation 37.1 |
| BTX 50 U in First and Second TPs | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 20 | -71.2 percent change | Standard Deviation 43.99 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 4 | -34.3 percent change | Standard Deviation 55.77 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 8 | -37.3 percent change | Standard Deviation 51.64 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 12 | -33.6 percent change | Standard Deviation 80.24 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 20 | 1.9 percent change | Standard Deviation 108.77 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 24 | 8.6 percent change | Standard Deviation 105.13 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 16 | -5.2 percent change | Standard Deviation 109.55 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 1 | -44.5 percent change | Standard Deviation 53.32 |
Secondary
Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase
A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. Percent change from Baseline in the Second Treatment phase was calculated as follows: (mean weight at each visit minus mean weight at Baseline in the Second Treatment Phase) \* 100/mean weight at Baseline in the Second Treatment Phase.
Time frame: Baseline (Week 0); and Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 4 | -89.6 percent change | Standard Deviation 15.2 |
| BTX 50 U in First and Second TPs | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 8 | -86.2 percent change | Standard Deviation 16.76 |
| BTX 50 U in First and Second TPs | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 12 | -82.6 percent change | Standard Deviation 18.43 |
| BTX 50 U in First and Second TPs | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 16 | -77.6 percent change | Standard Deviation 32.23 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 16 | -84.5 percent change | Standard Deviation 24.87 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 4 | -84.6 percent change | Standard Deviation 31.18 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 12 | -87.6 percent change | Standard Deviation 21.14 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 8 | -84.4 percent change | Standard Deviation 33.85 |
| Total | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 16 | -82.1 percent change | Standard Deviation 27.65 |
| Total | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 8 | -85.0 percent change | Standard Deviation 29.04 |
| Total | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 12 | -85.9 percent change | Standard Deviation 20.3 |
| Total | Mean Percent Change From Baseline in Mean Weight of Axillary Sweating at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 4 | -86.3 percent change | Standard Deviation 26.8 |
Secondary
Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase
A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.
Time frame: Week 0 (Baseline); Weeks 1, 4, 8, 12, 16, 20, and 24
Population: FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 24 | 44.27 milligrams (mg) | Standard Deviation 71.909 |
| BTX 50 U in First and Second TPs | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 8 | 15.47 milligrams (mg) | Standard Deviation 24.471 |
| BTX 50 U in First and Second TPs | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 1 | 17.58 milligrams (mg) | Standard Deviation 21.725 |
| BTX 50 U in First and Second TPs | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 12 | 17.99 milligrams (mg) | Standard Deviation 28.38 |
| BTX 50 U in First and Second TPs | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 0 (Baseline) | 125.16 milligrams (mg) | Standard Deviation 85.366 |
| BTX 50 U in First and Second TPs | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 16 | 18.60 milligrams (mg) | Standard Deviation 26.827 |
| BTX 50 U in First and Second TPs | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 4 | 18.90 milligrams (mg) | Standard Deviation 36.5 |
| BTX 50 U in First and Second TPs | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 20 | 24.90 milligrams (mg) | Standard Deviation 31.793 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 24 | 135.36 milligrams (mg) | Standard Deviation 159.123 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 20 | 127.30 milligrams (mg) | Standard Deviation 161.965 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 0 (Baseline) | 137.45 milligrams (mg) | Standard Deviation 128.215 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 1 | 81.30 milligrams (mg) | Standard Deviation 117.296 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 4 | 82.92 milligrams (mg) | Standard Deviation 98.94 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 8 | 80.43 milligrams (mg) | Standard Deviation 121.172 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 12 | 68.31 milligrams (mg) | Standard Deviation 67.493 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 16 | 115.44 milligrams (mg) | Standard Deviation 157.71 |
Secondary
Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase
A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.
Time frame: Baseline (Week 0); Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase
Population: FAS2 (LOCF dataset)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 12 | 15.22 mg | Standard Deviation 27.057 |
| BTX 50 U in First and Second TPs | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 8 | 11.37 mg | Standard Deviation 26.561 |
| BTX 50 U in First and Second TPs | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Baseline (Week 0) | 84.50 mg | Standard Deviation 92.872 |
| BTX 50 U in First and Second TPs | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 4 | 6.69 mg | Standard Deviation 7.513 |
| BTX 50 U in First and Second TPs | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 16 | 12.87 mg | Standard Deviation 15.458 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 8 | 17.82 mg | Standard Deviation 36.049 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Baseline (Week 0) | 145.39 mg | Standard Deviation 163.635 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 4 | 17.25 mg | Standard Deviation 35.386 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 12 | 14.20 mg | Standard Deviation 20.411 |
| Placebo in First TP; BTX 50 U in Second TP | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 16 | 14.49 mg | Standard Deviation 21.217 |
| Total | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 16 | 13.94 mg | Standard Deviation 19.366 |
| Total | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 12 | 14.55 mg | Standard Deviation 22.778 |
| Total | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Baseline (Week 0) | 124.48 mg | Standard Deviation 145.725 |
| Total | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 8 | 15.61 mg | Standard Deviation 33.102 |
| Total | Mean Weight of Axillary Sweating by Gravimetric Measurement at Baseline and Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 4 | 13.62 mg | Standard Deviation 29.363 |
Secondary
Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase
The participant's global assessment of treatment satisfaction is a method used to evaluate a participant's treatment satisfaction. Participants rated any improvement or worsening of their symptoms compared to Baseline by using the following 9-point scale: +4, Complete abolishment of signs and symptoms; +3, Marked improvement; +2, Moderate improvement; +1, Slight improvement; 0, Unchanged; -1, Slight worsening; -2, Moderate worsening; -3, Marked worsening; and -4, Very marked worsening.
Time frame: Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Population: FAS1. The number of participants analyzed varies by week because some participants were prematurely withdrawn, had no efficacy assessment at a particular time point, or were entered into the Second Treatment Phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 12, n=76, 73 | 2.6 scores on a scale | Standard Deviation 1.33 |
| BTX 50 U in First and Second TPs | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 24, n=56, 15 | 2.5 scores on a scale | Standard Deviation 1.21 |
| BTX 50 U in First and Second TPs | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 8, n=78, 73 | 2.7 scores on a scale | Standard Deviation 1.16 |
| BTX 50 U in First and Second TPs | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 28, n=42, 6 | 2.9 scores on a scale | Standard Deviation 0.88 |
| BTX 50 U in First and Second TPs | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 16, n=76, 73 | 2.6 scores on a scale | Standard Deviation 1.23 |
| BTX 50 U in First and Second TPs | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 32, n=40, 7 | 2.6 scores on a scale | Standard Deviation 1.37 |
| BTX 50 U in First and Second TPs | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 4, n=78, 73 | 2.6 scores on a scale | Standard Deviation 10.7 |
| BTX 50 U in First and Second TPs | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 36, n=41, 7 | 2.5 scores on a scale | Standard Deviation 1.31 |
| BTX 50 U in First and Second TPs | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 20, n=65, 24 | 2.6 scores on a scale | Standard Deviation 1.14 |
| BTX 50 U in First and Second TPs | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 40, n=40, 7 | 2.4 scores on a scale | Standard Deviation 1.35 |
| BTX 50 U in First and Second TPs | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 1, n=78, 74 | 1.8 scores on a scale | Standard Deviation 1.28 |
| Placebo in First TP; BTX 50 U in Second TP | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 40, n=40, 7 | 1.1 scores on a scale | Standard Deviation 1.46 |
| Placebo in First TP; BTX 50 U in Second TP | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 1, n=78, 74 | 0.6 scores on a scale | Standard Deviation 0.95 |
| Placebo in First TP; BTX 50 U in Second TP | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 4, n=78, 73 | 0.5 scores on a scale | Standard Deviation 1.05 |
| Placebo in First TP; BTX 50 U in Second TP | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 8, n=78, 73 | 0.3 scores on a scale | Standard Deviation 0.96 |
| Placebo in First TP; BTX 50 U in Second TP | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 12, n=76, 73 | 0.4 scores on a scale | Standard Deviation 0.86 |
| Placebo in First TP; BTX 50 U in Second TP | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 16, n=76, 73 | 0.4 scores on a scale | Standard Deviation 0.83 |
| Placebo in First TP; BTX 50 U in Second TP | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 20, n=65, 24 | 0.5 scores on a scale | Standard Deviation 1.06 |
| Placebo in First TP; BTX 50 U in Second TP | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 24, n=56, 15 | 0.9 scores on a scale | Standard Deviation 1.22 |
| Placebo in First TP; BTX 50 U in Second TP | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 28, n=42, 6 | 1.0 scores on a scale | Standard Deviation 1.26 |
| Placebo in First TP; BTX 50 U in Second TP | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 32, n=40, 7 | 1.3 scores on a scale | Standard Deviation 1.38 |
| Placebo in First TP; BTX 50 U in Second TP | Participant's Global Assessment of Treatment Satisfaction in the First Treatment Phase | Week 36, n=41, 7 | 1.0 scores on a scale | Standard Deviation 1.63 |
Secondary
Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase
Participant's global assessment of treatment satisfaction is a method used to evaluate a participant's treatment satisfaction. Participants rated any improvement or worsening of their symptoms compared to Baseline by using the following 9-point scale: +4, Complete abolishment of signs and symptoms; +3, Marked improvement; +2, Moderate improvement; +1, Slight improvement; 0, Unchanged; -1, Slight worsening; -2, Moderate worsening; -3, Marked worsening; and -4, Very marked worsening.
Time frame: Weeks 4 (Study Week 20 to Week 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BTX 50 U in First and Second TPs | Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | Week 4, n=34, 65, 99 | 3.2 scores on a scale | Standard Deviation 0.88 |
| BTX 50 U in First and Second TPs | Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | Week 16, n=34, 62, 96 | 2.6 scores on a scale | Standard Deviation 1.35 |
| BTX 50 U in First and Second TPs | Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | Week 24, n=10, 49, 59 | 1.7 scores on a scale | Standard Deviation 1.34 |
| BTX 50 U in First and Second TPs | Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | Week 8, n=34, 65, 99 | 3.0 scores on a scale | Standard Deviation 1.14 |
| BTX 50 U in First and Second TPs | Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | Week 20, n=20, 56, 76 | 2.3 scores on a scale | Standard Deviation 1.29 |
| BTX 50 U in First and Second TPs | Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | Week 12, n=34, 64, 98 | 2.8 scores on a scale | Standard Deviation 1.14 |
| Placebo in First TP; BTX 50 U in Second TP | Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | Week 20, n=20, 56, 76 | 2.3 scores on a scale | Standard Deviation 1.46 |
| Placebo in First TP; BTX 50 U in Second TP | Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | Week 24, n=10, 49, 59 | 2.1 scores on a scale | Standard Deviation 1.52 |
| Placebo in First TP; BTX 50 U in Second TP | Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | Week 12, n=34, 64, 98 | 2.7 scores on a scale | Standard Deviation 1.27 |
| Placebo in First TP; BTX 50 U in Second TP | Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | Week 4, n=34, 65, 99 | 2.8 scores on a scale | Standard Deviation 1.1 |
| Placebo in First TP; BTX 50 U in Second TP | Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | Week 8, n=34, 65, 99 | 2.8 scores on a scale | Standard Deviation 1.09 |
| Placebo in First TP; BTX 50 U in Second TP | Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | Week 16, n=34, 62, 96 | 2.6 scores on a scale | Standard Deviation 1.36 |
| Total | Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | Week 16, n=34, 62, 96 | 2.6 scores on a scale | Standard Deviation 1.35 |
| Total | Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | Week 8, n=34, 65, 99 | 2.9 scores on a scale | Standard Deviation 1.11 |
| Total | Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | Week 12, n=34, 64, 98 | 2.7 scores on a scale | Standard Deviation 1.22 |
| Total | Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | Week 4, n=34, 65, 99 | 2.9 scores on a scale | Standard Deviation 1.04 |
| Total | Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | Week 20, n=20, 56, 76 | 2.3 scores on a scale | Standard Deviation 1.41 |
| Total | Participant's Global Assessment of Treatment Satisfaction in the Second Treatment Phase | Week 24, n=10, 49, 59 | 2.0 scores on a scale | Standard Deviation 1.49 |
Secondary
Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase
A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline in mean weight of axillary sweating.
Time frame: Weeks 1, 8 ,12, 16, 20, and 24
Population: FAS1 (LOCF dataset). In the first treatment phase, the imputation of missing data by LOCF was performed up to Week 24; the missing data after Week 24 in the first treatment phase were not imputed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 8 | 94.9 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 16 | 87.2 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 20 | 74.4 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 12 | 89.7 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 24 | 56.4 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 1 | 93.6 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 24 | 9.5 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 1 | 52.7 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 8 | 48.6 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 12 | 62.2 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 16 | 32.4 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 1, 8, 12, 16, 20, and 24 in the First Treatment Phase | Week 20 | 20.3 percentage of participants |
Secondary
Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase
A pre-weighed filter paper was placed into the axilla area to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced. A responder was defined as a participant showing at least a 50% reduction from Baseline (Week 0 in the Second Treatment Phase) in mean weight of axillary sweating.
Time frame: Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), and 16 (Study Week 32 to 40) in the Second Treatment Phase
Population: FAS for the Second Treatment Phase (FAS2) (LOCF dataset): all participants who were included in the FAS1, received the second treatment of IP, and had at least one efficacy assessment after the second treatment. One participant who started the Second Treatment Phase was not included in the FAS2 because they had no efficacy assessment in this phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 4 | 97.1 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 8 | 94.1 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 12 | 97.1 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 16 | 91.2 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 16 | 95.4 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 4 | 92.3 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 12 | 96.9 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 8 | 96.9 percentage of participants |
| Total | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 16 | 93.9 percentage of participants |
| Total | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 8 | 96.0 percentage of participants |
| Total | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 12 | 97.0 percentage of participants |
| Total | Percentage of Responders Assessed by Gravimetric Measurement at Weeks 4, 8, 12, and 16 in the Second Treatment Phase | Week 4 | 93.9 percentage of participants |
Secondary
Percentage of Responders Assessed by the HDSS in the Second Treatment Phase
The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. A responder was defined as a participant whose change from Baseline (Week 0 in the Second Treatment Phase) was equal to or less than -2.
Time frame: Weeks 4 (Study Week 20 to 28), 8 (Study Week 24 to 32), 12 (Study Week 28 to 36), 16 (Study Week 32 to 40), 20 (Study Week 36 to 40), and 24 (Study Week 40) in the Second Treatment Phase
Population: FAS2. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by the HDSS in the Second Treatment Phase | Week 4, n=34, 65, 99 | 11.8 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by the HDSS in the Second Treatment Phase | Week 8, n=34, 65, 99 | 14.7 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by the HDSS in the Second Treatment Phase | Week 12, n=34, 64, 98 | 8.8 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by the HDSS in the Second Treatment Phase | Week 16, n=34, 62, 96 | 2.9 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by the HDSS in the Second Treatment Phase | Week 20, n=20, 56, 76 | 0 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by the HDSS in the Second Treatment Phase | Week 24, n=10, 49, 59 | 0 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by the HDSS in the Second Treatment Phase | Week 24, n=10, 49, 59 | 36.7 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by the HDSS in the Second Treatment Phase | Week 4, n=34, 65, 99 | 47.7 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by the HDSS in the Second Treatment Phase | Week 16, n=34, 62, 96 | 43.5 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by the HDSS in the Second Treatment Phase | Week 20, n=20, 56, 76 | 37.5 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by the HDSS in the Second Treatment Phase | Week 8, n=34, 65, 99 | 43.1 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by the HDSS in the Second Treatment Phase | Week 12, n=34, 64, 98 | 48.4 percentage of participants |
| Total | Percentage of Responders Assessed by the HDSS in the Second Treatment Phase | Week 8, n=34, 65, 99 | 33.3 percentage of participants |
| Total | Percentage of Responders Assessed by the HDSS in the Second Treatment Phase | Week 12, n=34, 64, 98 | 34.7 percentage of participants |
| Total | Percentage of Responders Assessed by the HDSS in the Second Treatment Phase | Week 24, n=10, 49, 59 | 30.5 percentage of participants |
| Total | Percentage of Responders Assessed by the HDSS in the Second Treatment Phase | Week 16, n=34, 62, 96 | 29.2 percentage of participants |
| Total | Percentage of Responders Assessed by the HDSS in the Second Treatment Phase | Week 4, n=34, 65, 99 | 35.4 percentage of participants |
| Total | Percentage of Responders Assessed by the HDSS in the Second Treatment Phase | Week 20, n=20, 56, 76 | 27.6 percentage of participants |
Secondary
Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase
The HDSS is a 4-point scale (score range: 1-4) used to assess the impact of disease and the clinical relevance of treatment. Participants selected their underarm sweat condition from the following: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities, and 4=Intolerable and always interferes with my daily activities. A responder was defined as a participant whose change from Baseline was equal to or less than -2.
Time frame: Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40
Population: FAS1. The number of participants remaining in the study at the time of the visit, particularly regardless of reinjection after Week 16, was used as the denominator. The number of participants analyzed varies by week because some participants were prematurely withdrawn or had no efficacy assessment at a particular time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 32, n=74, 71 | 32.4 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 12, n=76, 73 | 57.9 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 28, n=76, 71 | 36.8 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 16, n=76, 73 | 57.9 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 4, n=78, 73 | 61.5 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 20, n=75, 73 | 48.0 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 40, n=74, 70 | 27.0 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 24, n=76, 72 | 38.2 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 8, n=78, 73 | 66.7 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 36, n=75, 70 | 30.7 percentage of participants |
| BTX 50 U in First and Second TPs | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 1, n=78, 74 | 32.1 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 36, n=75, 70 | 4.3 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 24, n=76, 72 | 6.9 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 32, n=74, 71 | 4.2 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 40, n=74, 70 | 4.3 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 1, n=78, 74 | 8.1 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 4, n=78, 73 | 13.7 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 8, n=78, 73 | 12.3 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 12, n=76, 73 | 13.7 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 16, n=76, 73 | 9.6 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 20, n=75, 73 | 9.6 percentage of participants |
| Placebo in First TP; BTX 50 U in Second TP | Percentage of Responders Assessed by the Hyperhidrosis Severity Scale (HDSS) in the First Treatment Phase | Week 28, n=76, 71 | 4.2 percentage of participants |