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Main Study: A Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area Sub-study: A Follow-up Study to Evaluate the Analysis of Mammograms Following Treatment for Correction of Wrinkles in Décolletage Area in the Investigational Study 43USRV1906
Sponsor: Galderma R&D
Summary
Main study: Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GAL1906 for the correction of wrinkles in the décolletage area. Sub-study: To evaluate imaging interpretation of mammograms in subjects who were enrolled and treated in the 43USRV1906 main study. The sub-study will determine if hyaluronic acid injections in the décolletage interfere with diagnosis or interpretation of mammogram results.
Official title: Main Study: A Randomized, Evaluator-blinded, No-treatment Controlled, Multicenter Study to Evaluate the Effectiveness and Safety of GAL1906 for Correction of Wrinkles in the décolletage Area Sub-study: A Follow-up Sub-study to Assess Interpretation of Mammograms Following Treatment for Correction of Wrinkles in the Décolletage Area in the Investigational Study 43USRV1906
Key Details
Gender
FEMALE
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
211
Start Date
2021-02-08
Completion Date
2025-06-13
Last Updated
2026-07-15
Healthy Volunteers
Yes
Conditions
Interventions
GAL1906
hyaluronic acid dermal filler gel
Locations (14)
Galderma Research Site
Birmingham, Alabama, United States
Galderma Research Site
Scottsdale, Arizona, United States
Galderma Research Site
Redondo Beach, California, United States
Galderma Research Site
San Diego, California, United States
Galderma Research Site
Vista, California, United States
Galderma Research Site
Westport, Connecticut, United States
Galderma Research Site
Boynton Beach, Florida, United States
Galderma Research Site
Coral Gables, Florida, United States
Galderma Research Site
Alpharetta, Georgia, United States
Galderma Research Site
Chicago, Illinois, United States
Galderma Research Site
Baltimore, Maryland, United States
Galderma Research Site
New York, New York, United States
Galderma Research Site
Spring, Texas, United States
Galderma Research Site
Mequon, Wisconsin, United States