Clinical Trials in the USA / NCT05987163
Active, not recruiting
Not applicable
Study to Evaluate the Safety and Effectiveness of GP0116
NCT05987163 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Skin Manifestations
Investigational drug(s) / intervention(s)
GP0116Active Comparator: FDA approved dermal filler device (RHA 3)
GP0116: GP0116 is an injectable, sterile, transparent product.
Active Comparator: FDA approved dermal filler device (RHA 3): FDA approved dermal filler device (RHA 3)
Study 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).
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
Primary outcome measure(s)
- To demonstrate non-inferiority of GP0116 versus a comparator control — At 3 months after Baseline
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).
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| Galderma Investigational Site (Site#8074) | Santa Monica | California | |
| Galderma Investigational Site (Site#8478) | Vista | California | |
| Galderma Investigational Site (Site#8680) | Westport | Connecticut | |
| Galderma Investigational Site (Site#8479) | Bradenton | Florida | |
| Galderma Investigational Site (Site#7030) | Coral Gables | Florida | |
| Galderma Investigational Site (Site#8284) | Coral Gables | Florida | |
| Galderma Investigational Site (Site#8126) | West Palm Beach | Florida | |
| Galderma Investigational Site (Site#7042) | Atlanta | Georgia | |
| Galderma Investigational Site (Site#8580) | New Orleans | Louisiana | |
| Galderma Investigational Site (Site#8481) | Chestnut Hill | Massachusetts | |
| Galderma Investigational Site (Site#8631) | Birmingham | Michigan | |
| Galderma Investigational Site (Site#8658) | New York | New York | |
| Galderma Investigational Site (Site#8482) | Chapel Hill | North Carolina | |
| Galderma Investigational Site (Site#8648) | Wilmington | North Carolina | |
| Galderma Investigational Site (Site#8783) | Cincinnati | Ohio | |
| Galderma Investigational Site (Site#8496) | Nashville | Tennessee | |
| Galderma Investigational Site (Site#8662) | Spring | Texas | |
| Galderma Investigational Site (Site#7047) | Arlington | Virginia | |
| Galderma Investigational Site (Site#8784) | San Juan | Puerto Rico |
More Galderma R&D trials in the USA
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05987163 on ClinicalTrials.gov ↗ ← All trials in the USA