Trials / Active Not Recruiting
Active Not RecruitingNCT05987163
Study to Evaluate the Safety and Effectiveness of GP0116
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.
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 186 (estimated)
- Sponsor
- Galderma R&D · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | GP0116 | GP0116 is an injectable, sterile, transparent product. |
| DEVICE | Active Comparator: FDA approved dermal filler device (RHA 3) | FDA approved dermal filler device (RHA 3) |
Timeline
- Start date
- 2023-04-12
- Primary completion
- 2024-10-29
- Completion
- 2026-03-31
- First posted
- 2023-08-14
- Last updated
- 2025-07-02
Locations
19 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05987163. Inclusion in this directory is not an endorsement.