Skin Manifestations Clinical Trial
— NLFOfficial 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.
Verified date | July 2023 |
Source | Galderma R&D |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 186 |
Est. completion date | March 31, 2026 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Galderma Investigational Site (Site#8783) | Cincinnati | Ohio |
United States | Galderma Investigational Site (Site#8580) | New Orleans | Louisiana |
United States | Galderma Investigational Site (Site#8126) | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Galderma R&D |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To demonstrate non-inferiority of GP0116 versus a comparator control | To demonstrate non-inferiority of GP0116 versus a comparator control in correction of NLFs by comparing change from baseline based on the Blinded Evaluator's live assessment of NLF correction at Month 3 using the Wrinkle Severity Rating Scale (WSRS). | At 3 months after Baseline |
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