Frown Lines
Conditions
Brief summary
The purpose of the study is to provide preliminary comparative data on BoNT/A-DP versus Botox Cosmetic. Subsequently the sample size is primarily based on clinical judgement and practical considerations.
Detailed description
This will be a multi-center, randomized, double-blind, comparator-controlled study. The study will take place in the EU, US and Canada. To allow all subjects to profit from treatment and to obtain adequate data for BoNT/A DP treatment, the study will be comprised of a double-blinded treatment comparing BoNT/A-DP with Botox Cosmetic (ratio 1:1). Primary and secondary endpoints will compare efficacy, safety and subject satisfaction after a single treatment of the investigational BoNT/A DP to an existing commercially available product (Botox Cosmetic). Two hundred subjects will be enrolled, which should allow for a precise estimate of response rate and for post-hoc sensitivity analyses. The duration of study participation for each subject will be up to 18 weeks, to include screening (maximum of 2 weeks; re-screening will not be permitted), and a single treatment (comprised of one injection at five injection points) of BoNT/A-DP (Group A) or Botox Cosmetic (Group B) followed by six efficacy and safety follow-up visits. A total of 200 subjects will be randomized 1:1 to Group A or Group B at Baseline. Both investigators and subjects will be blinded to treatment. Investigators and subjects will evaluate the severity of glabellar lines independently.
Interventions
BIOLOGICALBotulinum toxin A BoNT/A-DP
To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.
BIOLOGICALBotulinum toxin A Botox Cosmetics
To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.
Sponsors
Hugel
Croma-Pharma GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Eligible subjects will be randomized at Baseline (Day 0) to Group A or B in a 1:1 randomization scheme. Investigators and subjects will be blinded to the treatment administered and will evaluate the severity of glabellar lines independently. The subjects should perform their assessment independently and ideally before the investigator, to ensure they are not biased by the investigator. The same investigator must complete the Baseline assessments and FWS at Week 4 (primary endpoint assessments) for a given subject.
Intervention model description
Multi-center, randomized, double-blind, comparator-controlled study. The study will take place in the EU, US and Canada. The benefit of participation in this study is the expected reduction in the severity of glabellar frown lines. All subjects will benefit from free medical screenings and follow up.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
• Has moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on GLS-I/GLS-S) 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 GLS-S), without glasses obstructing the forehead area.
Exclusion criteria
* 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 study (other than the investigational treatment). * Known hypersensitivity to either 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 three months prior to Screening or planned during the study. o Apart from the procedures specified above, previous treatment with any facial aesthetic procedure in the glabellar area (including chemical peeling, injection with biodegradable fillers, photo rejuvenation) within 12 months prior to Screening or planned during the study. * Previous insertion of permanent material in the glabellar area, or planned insertion during the study. * Any planned or history of surgery in the glabellar area and/or canthal line area, or scars in the glabellar and/or canthal line. * Active skin disease/infection or irritation at the treatment area. * Inability to substantially lessen glabellar frown lines and or lateral canthal lines even by physically spreading them apart. * Use of a muscle relaxant within 2 weeks prior to Screening, or planned use 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 study. * 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 anesthetic (use of local anesthetic outside the glabellar area is permitted). * Participation in another clinical study within one month of Screening and throughout the study. * 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 | Description |
|---|---|---|
| Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 1 Points in FWS Score (at Maximum Frown) at Week 4 Visit Relative to Baseline, Based on Both the Investigators´ and the Subjects´ In-clinic Assessments. | week 4 | The primary endpoint is the percentage of subjects among BoNT/A-DP and Botox Cosmetic groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 1 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. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles. Subjects with missing in-clinic assessments with the FWS at Baseline or Week 4 were assigned as non-responders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Weeks 1, 2, 4, 8, 12 and 16 | The percentage of responders based on the independent investigator assessment and subject assessment at Weeks 1, 2, 4, 8, 12 and 16 after a single treatment with BoNT/A-DP and compared to a single treatment of Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 2 point reduction in FWS score at maximum frown over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Subjects with missing in-clinic assessments with the FWS at Baseline or the respective visit were assigned as non-responders. |
| Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Weeks 1, 2, 4, 8, 12 and 16 | The percentage of responders based on the independent investigator assessment and subject assessment at Weeks 1, 2, 4, 8, 12 and 16 after a single treatment with BoNT/A-DP and compared to a single treatment of Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 1 point reduction in FWS score at rest over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Subjects with missing in-clinic assessments with the FWS at Baseline or the respective visit were assigned as non-responders. |
| Time to Onset of Effect Based on Independent Investigator Assessment and Subject Assessment | From treatment at Day 0 to Week 4 | Time to onset of effect in days, as measured at Weeks 1, 2, and 4, based on independent investigator and subject assessments after a single treatment with BoNT/A-DP and compared to Botox Cosmetic. Onset of effect is defined as at least 1 point improvement in Glabellar Line Scale - Investigator (GLS-I) and Glabellar Line Scale - Subject (GLS-S) score relative to Baseline at maximum frown in glabellar lines. GLS-I and GLS-S both use the same 4-point scale, ranked as 0 (No lines/minimal lines), 1 (Mild lines), 2 (Moderate lines) and 3 (Severe lines). |
| Duration of Effect Based on Independent Investigator Assessment and Subject Assessment | 16 Weeks | For subjects who are responders at week 4, duration of effect in days is assessed based on independent investigator and subject assessments after a single treatment with BoNT/A-DP and compared to Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 1 point reduction in FWS score at maximum frown over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Effect is deemed to be lost when scores return to Baseline or worse values. Duration of effect is defined as (the date that loss of response occurred) - (date of single study treatment ) + 1. |
| Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Weeks 1, 2, 8, 12 and 16 | The percentage of responders based on the independent investigator assessment and subject assessment at Weeks 1, 2, 8, 12 and 16 after a single treatment with BoNT/A-DP and compared to a single treatment of Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 1 point reduction in FWS score at maximum frown over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Subjects with missing in-clinic assessments with the FWS at Baseline or the respective visit were assigned as non-responders. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs) | through study completion, an average of 16 weeks | Frequency, seriousness and severity of treatment-emergent adverse events (TEAEs), serious AEs (SAEs) and AEs of special interest (AESIs), as well as causal relationship to the study medication and the study procedure, during the entire study period. A subject with multiple occurrences of an adverse event is counted only once within the worst severity category. |
| Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16 | Weeks 1, 4, 12, and 16 | Summary of change from baseline in diastolic/systolic blood pressure at weeks 1, 4, 12 and 16 after a single treatment and compared to Botox Cosmetic. |
| Change From Baseline in Pulse Rate at Weeks 1, 4, 12 and 16 | Weeks 1, 4, 12, and 16 | Summary of change from baseline in pulse rate at weeks 1, 4, 12 and 16 after a single treatment and compared to Botox Cosmetic. |
| FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Weeks 4, 12 and 16 | Summary of FACE-Q satisfaction with outcome scale based on subject assessment at weeks 4, 12 and 16 after a single treatment and compared to Botox Cosmetic. The FACE-Q Satisfaction with Outcome scale is a patient-reported outcome measure designed to assess a patient's satisfaction with the results of a facial aesthetic procedure. This scale comprises six items, each with four response options: definitely agree, somewhat agree, somewhat disagree, and definitely disagree. |
Countries
Austria, Canada, United States
Participant flow
Pre-assignment details
Of 208 enrolled participants, 200 met inclusion criteria and were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Group A: BoNT/A-DP (20 U, 0.5 mL) The injection sites should be prepared according to standard clinical procedures..
A volume of 0.5 mL of the properly reconstituted BoNT/A-DP should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A BoNT/A-DP: To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown. | 99 |
| Group B: Botox Cosmetic (20 U, 0.5 mL) The injection sites should be prepared according to standard clinical procedures.
A volume of 0.5 mL of the properly reconstituted Botox Cosmetic should be drawn into the sterile syringe and any air bubbles in the syringe barrel expelled. The needle used to reconstitute the product should be removed and replaced with a sterile insulin or tuberculin-type syringe of 1 mL volume with 0.01 mL graduation and with the gauge range of 30 to 33 G, which the investigator routinely uses for toxin administration.
Each subject will receive a total of five i.m. injections of 4 U/0.1 mL (total of 20 U).
Botulinum toxin A Botox Cosmetics: To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown. | 100 |
| Total | 199 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Group A: BoNT/A-DP (20 U, 0.5 mL) | Group B: Botox Cosmetic (20 U, 0.5 mL) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 9 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 182 Participants | 90 Participants | 92 Participants |
| Age, Continuous | 48.5 years STANDARD_DEVIATION 11.69 | 48.9 years STANDARD_DEVIATION 11.36 | 48.1 years STANDARD_DEVIATION 12.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 39 Participants | 18 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 160 Participants | 81 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skintype Type I | 7 Participants | 2 Participants | 5 Participants |
| Fitzpatrick Skintype Type II | 65 Participants | 33 Participants | 32 Participants |
| Fitzpatrick Skintype Type III | 63 Participants | 31 Participants | 32 Participants |
| Fitzpatrick Skintype Type IV | 54 Participants | 27 Participants | 27 Participants |
| Fitzpatrick Skintype Type V | 5 Participants | 3 Participants | 2 Participants |
| Fitzpatrick Skintype Type VI | 5 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) White | 177 Participants | 87 Participants | 90 Participants |
| Region of Enrollment Austria | 45 participants | 22 participants | 23 participants |
| Region of Enrollment Canada | 73 participants | 39 participants | 34 participants |
| Region of Enrollment United States | 81 participants | 38 participants | 43 participants |
| Sex: Female, Male Female | 172 Participants | 86 Participants | 86 Participants |
| Sex: Female, Male Male | 27 Participants | 13 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 11 / 100 | 15 / 100 |
| serious Total, serious adverse events | 0 / 100 | 1 / 100 |
Outcome results
Primary
Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 1 Points in FWS Score (at Maximum Frown) at Week 4 Visit Relative to Baseline, Based on Both the Investigators´ and the Subjects´ In-clinic Assessments.
The primary endpoint is the percentage of subjects among BoNT/A-DP and Botox Cosmetic groups with a Facial Wrinkle Scale (FWS) score of 0 or 1 and an improvement of ≥ 1 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. FWS scores are a four-point rating scale as follows: 0 = no facial wrinkles; 1 = mild facial wrinkles; 2 = moderate facial wrinkles; and 3 = severe facial wrinkles. Subjects with missing in-clinic assessments with the FWS at Baseline or Week 4 were assigned as non-responders.
Time frame: week 4
Population: The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 1 Points in FWS Score (at Maximum Frown) at Week 4 Visit Relative to Baseline, Based on Both the Investigators´ and the Subjects´ In-clinic Assessments. | Responder based on Investigator's In-clinic Assessment | 95 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 1 Points in FWS Score (at Maximum Frown) at Week 4 Visit Relative to Baseline, Based on Both the Investigators´ and the Subjects´ In-clinic Assessments. | Responder based on Subject's In-clinic Assessment | 81 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 1 Points in FWS Score (at Maximum Frown) at Week 4 Visit Relative to Baseline, Based on Both the Investigators´ and the Subjects´ In-clinic Assessments. | Responder based on Investigator's In-clinic Assessment | 97 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 1 Points in FWS Score (at Maximum Frown) at Week 4 Visit Relative to Baseline, Based on Both the Investigators´ and the Subjects´ In-clinic Assessments. | Responder based on Subject's In-clinic Assessment | 88 Participants |
Secondary
Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16
Summary of change from baseline in diastolic/systolic blood pressure at weeks 1, 4, 12 and 16 after a single treatment and compared to Botox Cosmetic.
Time frame: Weeks 1, 4, 12, and 16
Population: The population consists of all subjects who received at least one injection with the study medication. Only subjects with available data at the respective visit were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16 | Diastolic Blood Pressure (mmHg) - Week 1 - Change from Baseline | 0.9 millimeters of mercury | Standard Deviation 8.48 |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16 | Diastolic Blood Pressure (mmHg) - Week 4 - Change from Baseline | 0.1 millimeters of mercury | Standard Deviation 8.29 |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16 | Diastolic Blood Pressure (mmHg) - Week 12 - Change from Baseline | -0.1 millimeters of mercury | Standard Deviation 9.64 |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16 | Diastolic Blood Pressure (mmHg) - Week 16 - Change from Baseline | 1.0 millimeters of mercury | Standard Deviation 9.3 |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16 | Systolic Blood Pressure (mmHg) - Week 1 - Change from Baseline | 0.2 millimeters of mercury | Standard Deviation 10.84 |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16 | Systolic Blood Pressure (mmHg) - Week 4 - Change from Baseline | 0.3 millimeters of mercury | Standard Deviation 11.44 |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16 | Systolic Blood Pressure (mmHg) - Week 12 - Change from Baseline | 0.6 millimeters of mercury | Standard Deviation 11.79 |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16 | Systolic Blood Pressure (mmHg) - Week 16 - Change from Baseline | 1.5 millimeters of mercury | Standard Deviation 12.3 |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16 | Systolic Blood Pressure (mmHg) - Week 16 - Change from Baseline | -1.5 millimeters of mercury | Standard Deviation 15.52 |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16 | Diastolic Blood Pressure (mmHg) - Week 1 - Change from Baseline | -1.9 millimeters of mercury | Standard Deviation 8.5 |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16 | Systolic Blood Pressure (mmHg) - Week 1 - Change from Baseline | -2.4 millimeters of mercury | Standard Deviation 12.29 |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16 | Diastolic Blood Pressure (mmHg) - Week 4 - Change from Baseline | -1.9 millimeters of mercury | Standard Deviation 8.8 |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16 | Systolic Blood Pressure (mmHg) - Week 12 - Change from Baseline | -1.3 millimeters of mercury | Standard Deviation 14.77 |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16 | Diastolic Blood Pressure (mmHg) - Week 12 - Change from Baseline | -1.2 millimeters of mercury | Standard Deviation 10.19 |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16 | Systolic Blood Pressure (mmHg) - Week 4 - Change from Baseline | -0.9 millimeters of mercury | Standard Deviation 12.78 |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Change From Baseline in Blood Pressure at Weeks 1, 4, 12 and 16 | Diastolic Blood Pressure (mmHg) - Week 16 - Change from Baseline | -1.6 millimeters of mercury | Standard Deviation 10.85 |
Secondary
Change From Baseline in Pulse Rate at Weeks 1, 4, 12 and 16
Summary of change from baseline in pulse rate at weeks 1, 4, 12 and 16 after a single treatment and compared to Botox Cosmetic.
Time frame: Weeks 1, 4, 12, and 16
Population: The population consists of all subjects who received at least one injection with the study medication. Only subjects with available data at the respective visit were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Change From Baseline in Pulse Rate at Weeks 1, 4, 12 and 16 | Pulse Rate (beats/min) - Week 1 - Change from Baseline | 2.2 beats/min | Standard Deviation 10.25 |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Change From Baseline in Pulse Rate at Weeks 1, 4, 12 and 16 | Pulse Rate (beats/min) - Week 4 - Change from Baseline | 1.0 beats/min | Standard Deviation 11.6 |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Change From Baseline in Pulse Rate at Weeks 1, 4, 12 and 16 | Pulse Rate (beats/min) - Week 12 - Change from Baseline | 1.2 beats/min | Standard Deviation 11.72 |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Change From Baseline in Pulse Rate at Weeks 1, 4, 12 and 16 | Pulse Rate (beats/min) - Week 16 - Change from Baseline | 1.9 beats/min | Standard Deviation 11.02 |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Change From Baseline in Pulse Rate at Weeks 1, 4, 12 and 16 | Pulse Rate (beats/min) - Week 16 - Change from Baseline | 0.5 beats/min | Standard Deviation 11.31 |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Change From Baseline in Pulse Rate at Weeks 1, 4, 12 and 16 | Pulse Rate (beats/min) - Week 1 - Change from Baseline | -0.4 beats/min | Standard Deviation 9.94 |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Change From Baseline in Pulse Rate at Weeks 1, 4, 12 and 16 | Pulse Rate (beats/min) - Week 12 - Change from Baseline | -0.2 beats/min | Standard Deviation 11.9 |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Change From Baseline in Pulse Rate at Weeks 1, 4, 12 and 16 | Pulse Rate (beats/min) - Week 4 - Change from Baseline | 1.6 beats/min | Standard Deviation 9.46 |
Secondary
Duration of Effect Based on Independent Investigator Assessment and Subject Assessment
For subjects who are responders at week 4, duration of effect in days is assessed based on independent investigator and subject assessments after a single treatment with BoNT/A-DP and compared to Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 1 point reduction in FWS score at maximum frown over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Effect is deemed to be lost when scores return to Baseline or worse values. Duration of effect is defined as (the date that loss of response occurred) - (date of single study treatment ) + 1.
Time frame: 16 Weeks
Population: The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Duration of Effect Based on Independent Investigator Assessment and Subject Assessment | Duration of effect for responders at Week 4 based on Investigator's in-clinic assessment | 132 Days |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Duration of Effect Based on Independent Investigator Assessment and Subject Assessment | Duration of effect for responders at Week 4 based on Subject's in-clinic assessment | 116 Days |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Duration of Effect Based on Independent Investigator Assessment and Subject Assessment | Duration of effect for responders at Week 4 based on Investigator's in-clinic assessment | NA Days |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Duration of Effect Based on Independent Investigator Assessment and Subject Assessment | Duration of effect for responders at Week 4 based on Subject's in-clinic assessment | NA Days |
Secondary
FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale.
Summary of FACE-Q satisfaction with outcome scale based on subject assessment at weeks 4, 12 and 16 after a single treatment and compared to Botox Cosmetic. The FACE-Q Satisfaction with Outcome scale is a patient-reported outcome measure designed to assess a patient's satisfaction with the results of a facial aesthetic procedure. This scale comprises six items, each with four response options: definitely agree, somewhat agree, somewhat disagree, and definitely disagree.
Time frame: Weeks 4, 12 and 16
Population: The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - fantastic | Somewhat agree | 25 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - pleased | Definitely disagree | 2 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - pleased | Somewhat disagree | 3 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - pleased | Somewhat agree | 17 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - pleased | Definitely agree | 77 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - pleased | Missing | 0 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - expected | Somewhat disagree | 5 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - expected | Somewhat agree | 33 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - expected | Definitely agree | 57 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - expected | Missing | 0 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - great | Definitely disagree | 2 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - great | Somewhat disagree | 8 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - great | Somewhat agree | 23 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - great | Definitely agree | 66 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - great | Missing | 0 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - look in the mirror | Definitely disagree | 1 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - look in the mirror | Somewhat disagree | 12 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - look in the mirror | Somewhat agree | 31 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - look in the mirror | Definitely agree | 55 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - look in the mirror | Missing | 0 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - fantastic | Definitely disagree | 4 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - fantastic | Somewhat disagree | 13 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - expected | Definitely disagree | 4 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - fantastic | Definitely agree | 57 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - fantastic | Missing | 0 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - miraculous | Definitely disagree | 11 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - miraculous | Somewhat disagree | 16 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - miraculous | Somewhat agree | 32 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - miraculous | Definitely agree | 40 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - miraculous | Missing | 0 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - pleased | Definitely disagree | 10 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - pleased | Somewhat disagree | 6 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - pleased | Somewhat agree | 28 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - pleased | Definitely agree | 50 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - pleased | Missing | 5 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - expected | Definitely disagree | 11 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - expected | Somewhat disagree | 11 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - expected | Somewhat agree | 29 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - expected | Definitely agree | 43 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - expected | Missing | 5 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - great | Definitely disagree | 9 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - great | Somewhat disagree | 14 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - great | Somewhat agree | 28 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - great | Definitely agree | 43 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - great | Missing | 5 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - look in the mirror | Definitely disagree | 13 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - look in the mirror | Somewhat disagree | 14 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - look in the mirror | Somewhat agree | 33 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - look in the mirror | Definitely agree | 34 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - look in the mirror | Missing | 5 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - fantastic | Definitely disagree | 12 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - fantastic | Somewhat disagree | 22 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - fantastic | Somewhat agree | 27 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - fantastic | Definitely agree | 33 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - fantastic | Missing | 5 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - miraculous | Definitely disagree | 25 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - miraculous | Somewhat disagree | 14 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - miraculous | Somewhat agree | 31 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - miraculous | Definitely agree | 24 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - miraculous | Missing | 5 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - pleased | Definitely disagree | 12 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - pleased | Somewhat disagree | 10 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - pleased | Somewhat agree | 21 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - pleased | Definitely agree | 54 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - pleased | Missing | 2 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - expected | Definitely disagree | 12 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - expected | Somewhat disagree | 14 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - expected | Somewhat agree | 31 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - expected | Definitely agree | 40 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - expected | Missing | 2 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - great | Definitely disagree | 10 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - great | Somewhat disagree | 20 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - great | Somewhat agree | 20 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - great | Definitely agree | 47 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - great | Missing | 2 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - look in the mirror | Definitely disagree | 12 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - look in the mirror | Somewhat disagree | 20 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - look in the mirror | Somewhat agree | 29 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - look in the mirror | Definitely agree | 36 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - look in the mirror | Missing | 2 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - fantastic | Definitely disagree | 17 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - fantastic | Somewhat disagree | 19 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - fantastic | Somewhat agree | 24 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - fantastic | Definitely agree | 37 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - fantastic | Missing | 2 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - miraculous | Definitely disagree | 26 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - miraculous | Somewhat disagree | 14 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - miraculous | Somewhat agree | 35 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - miraculous | Definitely agree | 22 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - miraculous | Missing | 2 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - expected | Somewhat agree | 31 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - expected | Definitely disagree | 0 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - look in the mirror | Definitely disagree | 4 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - pleased | Definitely disagree | 0 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - fantastic | Missing | 5 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - pleased | Somewhat disagree | 3 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - look in the mirror | Somewhat disagree | 15 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - pleased | Somewhat agree | 12 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - expected | Definitely agree | 46 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - pleased | Definitely agree | 84 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - look in the mirror | Somewhat agree | 36 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - pleased | Missing | 1 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - look in the mirror | Missing | 5 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - expected | Somewhat disagree | 6 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - look in the mirror | Definitely agree | 39 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - expected | Somewhat agree | 34 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - expected | Missing | 5 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - expected | Definitely agree | 59 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - look in the mirror | Missing | 6 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - expected | Missing | 1 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - miraculous | Somewhat agree | 33 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - great | Definitely disagree | 1 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - fantastic | Definitely disagree | 7 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - great | Somewhat disagree | 7 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - great | Definitely disagree | 8 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - great | Somewhat agree | 15 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - fantastic | Somewhat disagree | 18 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - great | Definitely agree | 76 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - fantastic | Definitely disagree | 10 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - great | Missing | 1 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - fantastic | Somewhat agree | 27 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - look in the mirror | Definitely disagree | 1 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - great | Somewhat disagree | 13 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - look in the mirror | Somewhat disagree | 8 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - fantastic | Definitely agree | 42 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - look in the mirror | Somewhat agree | 30 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - miraculous | Definitely disagree | 14 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - look in the mirror | Definitely agree | 60 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - fantastic | Missing | 6 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - look in the mirror | Missing | 1 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - great | Somewhat agree | 18 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - fantastic | Definitely disagree | 3 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - miraculous | Definitely disagree | 8 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - fantastic | Somewhat disagree | 11 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - fantastic | Somewhat disagree | 17 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - fantastic | Somewhat agree | 18 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - miraculous | Somewhat disagree | 27 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - fantastic | Definitely agree | 67 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - great | Definitely agree | 56 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - fantastic | Missing | 1 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - miraculous | Somewhat agree | 30 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - miraculous | Definitely disagree | 4 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - miraculous | Missing | 5 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - miraculous | Somewhat disagree | 19 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - miraculous | Definitely agree | 29 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - miraculous | Somewhat agree | 27 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - great | Missing | 5 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - miraculous | Definitely agree | 49 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - miraculous | Missing | 6 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 4 - miraculous | Missing | 1 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - fantastic | Somewhat agree | 21 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - pleased | Definitely disagree | 3 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - pleased | Definitely disagree | 5 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - pleased | Somewhat disagree | 7 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - look in the mirror | Definitely disagree | 11 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - pleased | Somewhat agree | 24 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - pleased | Somewhat disagree | 8 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - pleased | Definitely agree | 60 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - miraculous | Somewhat disagree | 20 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - pleased | Missing | 6 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - pleased | Somewhat agree | 20 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - expected | Definitely disagree | 6 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - look in the mirror | Somewhat disagree | 15 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - expected | Somewhat disagree | 9 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - pleased | Definitely agree | 62 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - expected | Somewhat agree | 33 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - fantastic | Definitely agree | 47 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - expected | Definitely agree | 46 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - pleased | Missing | 5 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - expected | Missing | 6 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - look in the mirror | Somewhat agree | 30 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - great | Definitely disagree | 5 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - expected | Definitely disagree | 6 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - great | Somewhat disagree | 12 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - miraculous | Definitely agree | 28 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - great | Somewhat agree | 22 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - expected | Somewhat disagree | 12 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - great | Definitely agree | 55 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 16 - look in the mirror | Definitely agree | 39 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | FACE-Q Satisfaction With Outcome Scale Based on Subject Assessment at Weeks 4, 12 and 16 Satisfaction With Outcome Scale. | Week 12 - great | Missing | 6 Participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs)
Frequency, seriousness and severity of treatment-emergent adverse events (TEAEs), serious AEs (SAEs) and AEs of special interest (AESIs), as well as causal relationship to the study medication and the study procedure, during the entire study period. A subject with multiple occurrences of an adverse event is counted only once within the worst severity category.
Time frame: through study completion, an average of 16 weeks
Population: The population consists of all subjects who received at least one injection with the study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs) | Subjects with any treatment-emergent adverse events | 25 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs) | Subjects with any serious treatment-emergent adverse events | 0 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs) | Subjects with any treatment-emergent adverse events of special interest | 0 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs) | Subjects with any severe treatment-emergent adverse events | 0 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs) | Subjects with any moderate treatment-emergent adverse events | 5 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs) | Subjects with any mild treatment-emergent adverse events | 20 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs) | Subjects with any treatment-emergent adverse events related to study medication | 4 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs) | Subjects with any treatment-emergent adverse events related to study procedure | 6 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs) | Subjects with any treatment-emergent adverse events related to study procedure | 8 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs) | Subjects with any treatment-emergent adverse events | 22 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs) | Subjects with any moderate treatment-emergent adverse events | 4 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs) | Subjects with any serious treatment-emergent adverse events | 1 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs) | Subjects with any treatment-emergent adverse events related to study medication | 3 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs) | Subjects with any treatment-emergent adverse events of special interest | 1 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs) | Subjects with any mild treatment-emergent adverse events | 18 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and AEs of Special Interest (AESIs) | Subjects with any severe treatment-emergent adverse events | 0 Participants |
Secondary
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16
The percentage of responders based on the independent investigator assessment and subject assessment at Weeks 1, 2, 8, 12 and 16 after a single treatment with BoNT/A-DP and compared to a single treatment of Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 1 point reduction in FWS score at maximum frown over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Subjects with missing in-clinic assessments with the FWS at Baseline or the respective visit were assigned as non-responders.
Time frame: Weeks 1, 2, 8, 12 and 16
Population: The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Responder Rate at Week 1 based on Investigator's In-clinic Assessment | 93 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Responder Rate at Week 1 based on Subject's In-clinic Assessment | 80 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Responder Rate at Week 2 based on Investigator's In-clinic Assessment | 93 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Responder Rate at Week 2 based on Subject's In-clinic Assessment | 83 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Responder Rate at Week 8 based on Investigator's In-clinic Assessment | 84 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Responder Rate at Week 8 based on Subject's In-clinic Assessment | 60 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Responder Rate at Week 12 based on Investigator's In-clinic Assessment | 66 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Responder Rate at Week 12 based on Subject's In-clinic Assessment | 43 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Responder Rate at Week 16 based on Investigator's In-clinic Assessment | 47 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Responder Rate at Week 16 based on Subject's In-clinic Assessment | 35 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Responder Rate at Week 12 based on Subject's In-clinic Assessment | 56 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Responder Rate at Week 1 based on Investigator's In-clinic Assessment | 90 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Responder Rate at Week 8 based on Subject's In-clinic Assessment | 76 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Responder Rate at Week 1 based on Subject's In-clinic Assessment | 83 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Responder Rate at Week 16 based on Subject's In-clinic Assessment | 46 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Responder Rate at Week 2 based on Investigator's In-clinic Assessment | 95 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Responder Rate at Week 12 based on Investigator's In-clinic Assessment | 78 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Responder Rate at Week 2 based on Subject's In-clinic Assessment | 91 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Responder Rate at Week 16 based on Investigator's In-clinic Assessment | 61 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 8, 12 and 16 | Responder Rate at Week 8 based on Investigator's In-clinic Assessment | 89 Participants |
Secondary
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
The percentage of responders based on the independent investigator assessment and subject assessment at Weeks 1, 2, 4, 8, 12 and 16 after a single treatment with BoNT/A-DP and compared to a single treatment of Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 1 point reduction in FWS score at rest over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Subjects with missing in-clinic assessments with the FWS at Baseline or the respective visit were assigned as non-responders.
Time frame: Weeks 1, 2, 4, 8, 12 and 16
Population: The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 1 based on Investigator's In-clinic Assessment | 57 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 1 based on Subject's In-clinic Assessment | 58 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 2 based on Investigator's In-clinic Assessment | 65 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 2 based on Subject's In-clinic Assessment | 70 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 4 based on Investigator's In-clinic Assessment | 67 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 4 based on Subject's In-clinic Assessment | 68 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 8 based on Investigator's In-clinic Assessment | 63 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 8 based on Subject's In-clinic Assessment | 57 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 12 based on Investigator's In-clinic Assessment | 58 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 12 based on Subject's In-clinic Assessment | 45 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 16 based on Investigator's In-clinic Assessment | 45 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 16 based on Subject's In-clinic Assessment | 36 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 16 based on Investigator's In-clinic Assessment | 52 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 1 based on Investigator's In-clinic Assessment | 53 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 8 based on Investigator's In-clinic Assessment | 62 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 1 based on Subject's In-clinic Assessment | 58 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 12 based on Subject's In-clinic Assessment | 48 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 2 based on Investigator's In-clinic Assessment | 64 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 8 based on Subject's In-clinic Assessment | 60 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 2 based on Subject's In-clinic Assessment | 64 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 16 based on Subject's In-clinic Assessment | 48 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 4 based on Investigator's In-clinic Assessment | 68 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 12 based on Investigator's In-clinic Assessment | 53 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 1 Point Reduction at Rest) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 4 based on Subject's In-clinic Assessment | 70 Participants |
Secondary
Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16
The percentage of responders based on the independent investigator assessment and subject assessment at Weeks 1, 2, 4, 8, 12 and 16 after a single treatment with BoNT/A-DP and compared to a single treatment of Botox Cosmetic. Responder is defined as having a Facial Wrinkle Scale (FWS) score of 0 or 1 and at least 2 point reduction in FWS score at maximum frown over Baseline, on the 4-point FWS. FWS scores are ranked as 0 (no facial wrinkles), 1 (mild facial wrinkles), 2 (moderate facial wrinkles) and 3 (severe facial wrinkles). Subjects with missing in-clinic assessments with the FWS at Baseline or the respective visit were assigned as non-responders.
Time frame: Weeks 1, 2, 4, 8, 12 and 16
Population: The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 1 based on Investigator's In-clinic Assessment | 80 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 1 based on Subject's In-clinic Assessment | 68 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 2 based on Investigator's In-clinic Assessment | 83 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 2 based on Subject's In-clinic Assessment | 75 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 4 based on Investigator's In-clinic Assessment | 82 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 4 based on Subject's In-clinic Assessment | 67 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 8 based on Investigator's In-clinic Assessment | 64 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 8 based on Subject's In-clinic Assessment | 44 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 12 based on Investigator's In-clinic Assessment | 37 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 12 based on Subject's In-clinic Assessment | 27 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 16 based on Investigator's In-clinic Assessment | 22 Participants |
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 16 based on Subject's In-clinic Assessment | 18 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 16 based on Investigator's In-clinic Assessment | 33 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 1 based on Investigator's In-clinic Assessment | 79 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 8 based on Investigator's In-clinic Assessment | 70 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 1 based on Subject's In-clinic Assessment | 72 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 12 based on Subject's In-clinic Assessment | 39 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 2 based on Investigator's In-clinic Assessment | 86 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 8 based on Subject's In-clinic Assessment | 65 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 2 based on Subject's In-clinic Assessment | 83 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 16 based on Subject's In-clinic Assessment | 32 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 4 based on Investigator's In-clinic Assessment | 88 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 12 based on Investigator's In-clinic Assessment | 52 Participants |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Responder Status (With a Facial Wrinkle Scale (FWS) Score of 0 or 1 and at Least 2 Point Reduction at Maximum Frown) Based on Independent Investigator Assessment and Subject Assessment at Weeks 1, 2, 4, 8, 12 and 16 | Responder Rate at Week 4 based on Subject's In-clinic Assessment | 81 Participants |
Secondary
Time to Onset of Effect Based on Independent Investigator Assessment and Subject Assessment
Time to onset of effect in days, as measured at Weeks 1, 2, and 4, based on independent investigator and subject assessments after a single treatment with BoNT/A-DP and compared to Botox Cosmetic. Onset of effect is defined as at least 1 point improvement in Glabellar Line Scale - Investigator (GLS-I) and Glabellar Line Scale - Subject (GLS-S) score relative to Baseline at maximum frown in glabellar lines. GLS-I and GLS-S both use the same 4-point scale, ranked as 0 (No lines/minimal lines), 1 (Mild lines), 2 (Moderate lines) and 3 (Severe lines).
Time frame: From treatment at Day 0 to Week 4
Population: The population consists of all randomized subjects who had a baseline visit and at least one post-dose in-clinic assessment with the 4-point Facial Wrinkle Scale by either the investigator or the subject at Weeks 1, 2, or 4.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A: BoNT/A-DP (20 U, 0.5 mL) | Time to Onset of Effect Based on Independent Investigator Assessment and Subject Assessment | 8.0 Days |
| Group B: Botox Cosmetic (20 U, 0.5 mL) | Time to Onset of Effect Based on Independent Investigator Assessment and Subject Assessment | 8.0 Days |