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Active Not RecruitingNANCT05987163

Study to Evaluate the Safety and Effectiveness of GP0116

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 ...

Lead sponsor: Galderma R&D•18 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Galderma R&D

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 2, 2025Terms

Trial snapshot

StatusACTIVE_NOT_RECRUITING

PhaseNA

Enrollment186

Start dateApr 2023

Last updatedJul 2, 2025

Condition

Skin Manifestations

Locations shown

Galderma Investigational Site (Site#8074)

Santa Monica, California

Galderma Investigational Site (Site#8478)

Vista, California

Galderma Investigational Site (Site#8680)

Westport, Connecticut

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 2, 2025Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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