Moderate to severe glabellar lines MedDRA version: 21.1 Level: LLT Classification code 10052609 Term: Glabellar frown lines System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Botulax
Product Name: BoNT/A-DP
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: Botulinum Neurotoxin Type A
CAS Number: 180016-51-6
Current Sponsor code:
Sponsors
Croma-Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet ALL the following criteria are eligible for this study: - Aged = 18 years or older at the time of screening (upper limit 75 years, inclusive). - Has moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on FWS) as determined by in-clinic assessments by both the investigator and the subject (where: 0= 'none', 1= 'mild', 2= 'moderate', 3= 'severe'). - Subject has a stable medical condition with no uncontrolled systemic disease. - Female subjects of childbearing potential must test negative for pregnancy and agree to use highly effective birth control during the course of the study. - Subjects who wear glasses must be able to adequately self-assess the severity of their glabellar lines (according to the FWS), without glasses obstructing the forehead area. - The moderate to severe glabellar lines have an important psychological impact on the subject, as indicated by scores >0 on either the Emotional or the Social Functioning subscale of the modified Skindex-16 (GL-QoL). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 310 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 43
Exclusion criteria
Exclusion criteria: Subjects who meet ANY of the following criteria are NOT eligible for this study: - Previous treatment with any serotype of botulinum toxin for any indication within the 12 months prior to screening, or any planned treatment with botulinum toxin of any serotype for any reason during the trial (other than the investigational treatment). - Known hypersensitivity to the study medication or its excipients. - Any medical condition that may place the subject at increased risk due to exposure to botulinum toxin, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, profound atrophy or weakness in the target muscles, or any other condition (at the investigator's discretion) that might interfere with neuromuscular function or contraindicate botulinum toxin therapy. - Facial laser or light treatment, microdermabrasion, superficial peels or retinoid therapy within the 3 months prior to screening or planned during the study. - Apart from the procedures specified above, previous treatment with any facial aesthetic procedure in the glabellar area (including chemical peeling, injection with biodegradable fillers,) within 12 months prior to screening or planned during the study. - Previous insertion of permanent material in the glabellar area or planned during the study. - Any surgery, or history of surgery, in the glabellar area including surgical removal of the corrugator, procerus or depressor supercili muscles or a combination of these, or scars in the glabellar area, or such surgery planned during the study. - Active skin disease/infection or irritation at the treatment area. - Inability to substantially lessen glabellar frown lines even by physically spreading them apart. - Use of a muscle relaxant, within 2 weeks prior to screening or planned during the study. - Marked facial asymmetry or ptosis of eyelid and/or eyebrow, or current facial palsy or neuromuscular junction disorders as judged by the investigator. - Pregnant, breastfeeding or planning to become pregnant during the trial. - Use of prohibited medication including anticholinergic drugs, or drugs which could interfere with neuromuscular function, including aminoglycoside antibiotics and curare-like compounds within 2 weeks prior to screening or planned during the study. - Planned surgery with general anaesthetic (use of local anaesthetic outside the glabellar area is permitted). - Participation in another clinical study within one month of screening and throughout the trial. - Previous participation in another botulinum toxin aesthetic study which involved the treatment of glabellar lines in combination with canthal lines and/or forehead lines in the previous 18 months. - Chronic drug or alcohol abuse (as per investigator discretion).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To assess the proportion of responders at maximum frown and at rest at various time points after each treatment, based on investigator and subject assessments. 2. To assess the psychological impact of BoNT/A-DP treatment on subjects (in terms of emotional and social functioning and concerns relating to their glabellar lines) in comparison with placebo after a single treatment. 3. To assess onset of effect and the duration of effect (at maximum frown) after a single treatment with BoNT/A-DP compared with placebo (first treatment cycle), based on investigator and subject assessments. 4. To provide long term safety data of BoNT/A-DP based on multiple treatment cycles and to establish a sufficient safety database to support regulatory approval. 5. To assess subject perceptions of effect of, and satisfaction with, treatment in comparison with placebo (first treatment cycle), and during the open-label extension phase.;Primary end point(s): The primary endpoint is the proportion of subjects among BoNT/A-DP and placebo groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of = 2 points in FWS score (at maximum frown) at week 4 visit (of the first treatment cycle) relative to baseline (responders), based on both the investigators' and the subjects' in-clinic assessments. Thus, the primary endpoint is a composite endpoint comprising investigator and subject assessments of treatment effectiveness.;Timepoint(s) of evaluation of this end point: At week 4 after each treatment ;Main Objective: To assess the efficacy of BoNT/A-DP in reducing the severity of glabellar frown lines following treatment (compared with placebo) based on investigator and subject assessment at week 4 (of the first treatment cycle). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Efficacy Endpoint 1. The extent of change in psychological impact (emotional and social functioning and concerns relating to their glabellar lines) at week 4 after the first treatment, in the BoNT/A-DP group in comparison with placebo, relative to baseline, as assessed by the modified Skindex-16 (Glabellar Line Quality of Life Scale [GL-QoL]) and the FACE-Q (Appraisal of Lines Between Eyebrows scale and Age Appraisal Visual Analog Scale (VAS)), respectively. Additional Secondary Endpoints 2. The percentage of responders at maximum frown at week 12 (after the first treatment with BoNT/A-DP or placebo). 3. The percentage of responders at week 16 (after the first treatment). 4. The percentage of responders at week 20 or later (after the first treatment). 5. The proportion of subjects with a = 1 point reduction in FWS score at rest at week 4 in the first treatment cycle, based separately on the investigators' and the subjects' in-clinic assessments (applicable only for subjects who have a FWS score at rest = 1 at baseline). 6. The proportion of responders among BoNT/ADP and placebo groups with a FWS score of 0 or 1 and an improvement = 2 points in FWS score (at maximum frown) during the first treatment cycle visit relative to baseline, based on both the investigator’s and the subject’s in-clinic assessments (composite endpoint, at weeks 1, 2 and 8). 7. The proportion of subjects with = 2 point and = 1 point reduction in FWS score (at maximum frown) in the BoNT/A-DP and placebo groups during the first treatment cycle visit relative to baseline, based on the independent rater’s assessment of photographs (at baseline and visits 2, 4, 12, 16 and 20 weeks after treatment, within the first treatment cycle). 8. Time to onset of effect in the BoNT/A-DP and placebo groups in the first treatment cycle, as measured at weeks 1, 2 and 4 based separately on subject and investigator assessments. Onset of effect defined as at least a 1 po | — |
Countries
Austria, United States
Contacts
Public ContactSonja Hoeller
CROMA-PHARMA GmbH
Outcome results
None listed