Study to Evaluate the Safety and Effectiveness of GP0116

Not Applicable

Active, not recruiting

• Conditions: Skin Manifestations
• Interventions: Device: GP0116

• Registration Number: NCT05987163
• Lead Sponsor: Galderma R&D

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-04
• Study Start: 2023-04-12
• Study First Submitted QC: 2023-08-09
• Study First Posted: 2023-08-14
• Primary Completion: 2024-10-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-26
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GP0116	GP0116	-

Primary Outcome Measures

Name	Time	Method
To demonstrate non-inferiority of GP0116 versus a comparator control	At 3 months after Baseline	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).

Trial Locations

Locations (19)

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#7042); 🇺🇸 Atlanta, Georgia, 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#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

Galderma Investigational Site (Site#8126); 🇺🇸 West Palm Beach, Florida, United States

Galderma Investigational Site (Site#8580); 🇺🇸 New Orleans, Louisiana, United States

Galderma Investigational Site (Site#8783); 🇺🇸 Cincinnati, Ohio, United States