Status:
ACTIVE_NOT_RECRUITING
Study to Evaluate the Safety and Effectiveness of GP0116
Lead Sponsor:
Galderma R&D
Conditions:
Skin Manifestations
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- Men and non-pregnant, non-breastfeeding women aged 22 years or older.
- WSRS grade of 3 or 4 (moderate to severe folds) on each NLF as assessed by the Blinded Evaluator. The WSRS for each NLF does not need to be equal.
- Intent to undergo treatment for correction of both left and right NLF.
Exclusion
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel
- Known/previous allergy or hypersensitivity to local anesthetics
- Previous or present severe or multiple allergies manifested by severe reactions
- Previous facial surgery near the treatment area
Key Trial Info
Start Date :
April 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT05987163
Start Date
April 12 2023
End Date
March 31 2026
Last Update
July 2 2025
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
Galderma Investigational Site (Site#8074)
Santa Monica, California, United States, 90404
2
Galderma Investigational Site (Site#8478)
Vista, California, United States, 92083
3
Galderma Investigational Site (Site#8680)
Westport, Connecticut, United States, 06880
4
Galderma Investigational Site (Site#8479)
Bradenton, Florida, United States, 34209