Study to Evaluate the Safety and Effectiveness of GP0116

N/AActive Not RecruitingNCT05987163

Galderma R&D186 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

186

Conditions

Skin Manifestations

Interventions

GP0116DEVICE

GP0116 is an injectable, sterile, transparent product.

Active Comparator: FDA approved dermal filler device (RHA 3)DEVICE

FDA approved dermal filler device (RHA 3)

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (19)

Galderma Investigational Site (Site#8074)

Santa Monica, California, United States

Outcomes

Primary Outcomes

To demonstrate non-inferiority of GP0116 versus a comparator control

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).

Time frame: At 3 months after Baseline

Data from ClinicalTrials.gov

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