Study to Evaluate the Safety and Effectiveness of GP0116

Running, not enrolling · Not applicable

Conditions studied: Skin Manifestations

In brief

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).

Key facts

Study ID

NCT05987163

Run by

Galderma R&D

People needed

186

Starts

2023-04-12

Expected to finish

2026-03-31

Last updated by the study team

2025-07-02

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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