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Study to Evaluate the Safety and Effectiveness of GP0116
Sponsor: Galderma R&D
Summary
This is a prospective, randomized, evaluator-blinded, comparator-controlled, parallel group, multicenter study in the U.S. for correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLFs).
Official title: A Randomized, Evaluator-blinded, Parallel Group, Comparator-controlled, Multicenter Study to Evaluate the Safety and Effectiveness of GP0116 for Correction of Moderate to Severe Dynamic Facial Wrinkles and Folds, Such as Nasolabial Folds.
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
186
Start Date
2023-04-12
Completion Date
2026-03-31
Last Updated
2025-07-02
Healthy Volunteers
No
Conditions
Interventions
GP0116
GP0116 is an injectable, sterile, transparent product.
Active Comparator: FDA approved dermal filler device (RHA 3)
FDA approved dermal filler device (RHA 3)
Locations (19)
Galderma Investigational Site (Site#8074)
Santa Monica, California, United States
Galderma Investigational Site (Site#8478)
Vista, California, United States
Galderma Investigational Site (Site#8680)
Westport, Connecticut, United States
Galderma Investigational Site (Site#8479)
Bradenton, Florida, United States
Galderma Investigational Site (Site#7030)
Coral Gables, Florida, United States
Galderma Investigational Site (Site#8284)
Coral Gables, Florida, United States
Galderma Investigational Site (Site#8126)
West Palm Beach, Florida, United States
Galderma Investigational Site (Site#7042)
Atlanta, Georgia, United States
Galderma Investigational Site (Site#8580)
New Orleans, Louisiana, United States
Galderma Investigational Site (Site#8481)
Chestnut Hill, Massachusetts, United States
Galderma Investigational Site (Site#8631)
Birmingham, Michigan, United States
Galderma Investigational Site (Site#8658)
New York, New York, United States
Galderma Investigational Site (Site#8482)
Chapel Hill, North Carolina, United States
Galderma Investigational Site (Site#8648)
Wilmington, North Carolina, United States
Galderma Investigational Site (Site#8783)
Cincinnati, Ohio, United States
Galderma Investigational Site (Site#8496)
Nashville, Tennessee, United States
Galderma Investigational Site (Site#8662)
Spring, Texas, United States
Galderma Investigational Site (Site#7047)
Arlington, Virginia, United States
Galderma Investigational Site (Site#8784)
San Juan, Puerto Rico