Open Label Extension for 43USSA1812
Not Applicable
Completed
- Conditions
- CheekWrinkle
- Interventions
- Device: Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection
- Registration Number
- NCT04595331
- Lead Sponsor
- Galderma R&D
- Brief Summary
To evaluate long-term safety and effectiveness data of Sculptra Aesthetic beyond the Month 12 duration of the pivotal study 43USSA1812 (NCT04124692) to help characterize the long-term safety and effectiveness profile of the more dilute suspension.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
- Subject completed Month 12 of study 43USSA1812
- Subjects willing to comply with the requirements of the extension of the study and providing a signed written informed consent.
Exclusion Criteria
- For subjects eligible for treatment in the extension study, the exclusion criteria for study 43USSA1812 applies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Control Group in the pivotal study Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection receiving treatment in the extension study
- Primary Outcome Measures
Name Time Method Responder rate for a single regimen of Sculptra Aesthetic in the correction of cheek wrinkles Month 24 A responder is defined as a subject with at least 1 grade improvement from pre-treatment on both cheeks concurrently
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Galderma Research Site
🇺🇸Spring, Texas, United States
Galderma Research site
🇺🇸San Diego, California, United States