GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Not Applicable
Completed
- Conditions
- Cheek Augmentation
- Registration Number
- NCT03700047
- Lead Sponsor
- Galderma R&D
- Brief Summary
An interventional study to evaluate the safety and effectiveness of GAL1704 for cheek augmentation and the correction of midface volume deficiencies by demonstrating non-inferiority in change from baseline, relative to an active comparator.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
Inclusion Criteria
- Subjects assessed at baseline by the Blinded Evaluator as Grade 2, 3, or 4 on the MMVS on each side of the midface.
Exclusion Criteria
- Previous use of any HA based or collagen based biodegradable tissue augmentation therapy within 12 months prior to the baseline visit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Assess Efficacy of Study Treatment Using Medicis Midface Volume Score (MMVS) 12 weeks Change in midface fullness from Baseline to 12 weeks using the Medicis Midface Volume Score (MMVS), where a decreasing score correlates with increasing midface fullness, namely a score of 1 being the most full and a score of 4 being the least full.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Galderma Study site
🇺🇸Dallas, Texas, United States
Galderma Study Site
🇺🇸Salt Lake City, Utah, United States
Galderma study site
🇺🇸Bellaire, Texas, United States
Galderma Study site🇺🇸Dallas, Texas, United States