Assess Aesthetic Improvement With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines
Phase 3
Completed
- Conditions
- Glabellar Frown LinesCanthal Lines
- Interventions
- Biological: QM1114-DP
- Registration Number
- NCT05148000
- Lead Sponsor
- Galderma R&D
- Brief Summary
This study to assess aesthetic improvement following treatment with QM1114-DP.
- Detailed Description
This is an open-label, single-center multi-center study to assess aesthetic improvement in the Glabellar and Lateral Canthal regions following treatment with QM1114-DP.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- Male or Female 18 years or older
- Moderate to severe bilaterally symmetrical LCL as assessed by the investigator
- Moderate to severe GL at maximum frown as assessed by the Investigator
Exclusion Criteria
- Previous use of any botulinum toxin in facial areas within 9 months prior to study treatment
- Female who is pregnant, breast feeding or intends to conceive a child during the study.
- Known allergy to hypersensitivity or any component of the Investigational product
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description QM1114-DP QM1114-DP QM1114-DP
- Primary Outcome Measures
Name Time Method Responders in QM1114-DP versus Placebo using the Global Aesthetic Improvement Scale (GAIS) at maximum frown at Month 1 1 month Responder Rate is defined as a subject who responds at least Improved on the GAIS at maximum frown
Responders in QM1114-DP versus Placebo using the Global Aesthetic Improvement Scale (GAIS) at maximum smile at Month 1 1 month Responder Rate is defined as a subject who responds at least Improved on the GAIS at maximum smile
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Galderma Research Site
🇺🇸New York, New York, United States