Moderate to severe Lateral Canthal Lines MedDRA version: 12.1 Level: LLT Classification code 10052609 Term: Glabellar frown lines
Conditions
Interventions
Trade Name: Azzalure®
Pharmaceutical Form: Powder for solution for injection
CAS Number: 93384-43-1
Current Sponsor code: CD07743
Other descriptive name: BOTULINUM TOXIN TYPE A
Concentration unit: SU
Sponsors
Galderma R&D SNC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female subjects, 18 to 65 years of age with moderate or severe (grade 2 or 3) Lateral Canthal Lines at maximum smile and with mild to severe (grade 1, 2, or 3) Lateral Canthal Lines at rest. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range ;Inclusion criteria: Male and female subjects, 18 to 65 years of age with moderate or severe (grade 2 or 3) Lateral Canthal Lines at maximum smile and with mild to severe (grade 1, 2, or 3) Lateral Canthal Lines at rest. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who had any prior surgery affecting the orbicularis oculi muscle, prior blepharoplasty or brow lift, or any prior cosmetic procedures or scars that may interfere with the evaluation of the study results will not be included in this study ;Exclusion criteria: Subjects who had any prior surgery affecting the orbicularis oculi muscle, prior blepharoplasty or brow lift, or any prior cosmetic procedures or scars that may interfere with the evaluation of the study results will not be included in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part A: initial treatment in CL (placebo-controlled): - To assess the efficacy, safety and duration of effect of Azzalure® compared to placebo in the improvement of moderate to severe Lateral Canthal Lines. - To assess the subjects’ level of satisfaction with the appearance their Lateral Canthal Lines compared to placebo. Part B: repeated treatment in CL with or without GL (active treatment, up to 1 year): - To assess safety of Azzalure® following repeated administration in the improvement of moderate to severe Lateral Canthal Lines. - To assess the safety of Azzalure® when used concomitantly for improvement of moderate to severe Lateral Canthal Lines and Glabellar Lines. - To assess the subjects’ level of satisfaction with the appearance their Lateral Canthal Lines. ;Secondary Objective: Secondary efficacy objectives: Key secondary: To determine the subjects’ level of satisfaction with the appearance of their CL following treatment with Azzalure® compared with placebo at Week 4 and similarly up Week 16. Other secondary: To determine the efficacy of Azzalure® in the improvement of CL “at rest” compared with placebo at Week 4, and similarly up to Week 16. To determine the safety of Azzalure® - compared with placebo up to 12 weeks - following repeated administration in CL up to 1 year - when used concomitantly in CL and GL ;Primary end point(s): Primary efficacy endpoint: To determine the efficacy of Azzalure® (30 S.U./half face) in the improvement, from baseline to Week 4, of moderate to severe CL “at maximum smile” compared with placebo. In order to determine the duration of effect, the efficacy of Azzalure® in the improvement of moderate to severe CL “at maximum smile” will be compared with placebo at Week 8, 12 and 16.;Main Objective: Part A: initial treatment in CL (placebo-controlled): - To assess the efficacy, safety and duration of effect of Azzalure® compared to placebo in the improvement of moderate to severe Lateral Canth | — |
Countries
Germany, United Kingdom
Contacts
Public Contact; ;
;
Outcome results
None listed