Active — Not RecruitingNot Applicable

Study to Evaluate the Safety and Effectiveness of GP0116

United States186 participantsStarted 2023-04-12

Plain-language 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).

Who can participate

Age range22 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

To demonstrate non-inferiority of GP0116 versus a comparator control

Timeframe: At 3 months after Baseline

Trial details

NCT IDNCT05987163

SponsorGalderma R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-29

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