Study to Evaluate the Safety and Effectiveness of GP0116 (NLF)

Galderma

Status: Active, not recruiting

Conditions: Skin Manifestations

Treatments: Device: Active Comparator: FDA approved dermal filler device; Device: GP0116

Study type: Interventional

Funder types: Industry

Identifiers

NCT05987163

43N3US2204

Details and patient eligibility

About

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).

Enrollment: 186 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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186 participants in 2 patient groups

GP0116

Experimental group

Treatment:

Device: GP0116

FDA Approved Device

Active Comparator group

Treatment:

Device: Active Comparator: FDA approved dermal filler device