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

A Randomized, Evaluator-blinded, Parallel Group, Comparator-controlled, Multicenter Study to Evaluate the Safety and Effectiveness of GP0116 for Correction of Moderate to Severe Dynamic Facial Wrinkles and Folds, Such as Nasolabial Folds.

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 Overview

• Status: Active, not recruiting
• Conditions: Skin Manifestations
• Intervention / Treatment: Device: GP0116; Device: Active Comparator: FDA approved dermal filler device

• Study Type: Interventional
• Enrollment (Estimated): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • West Palm Beach, Florida, United States, 33401
      • Galderma Investigational Site (Site#8126)
  • Louisiana
    • New Orleans, Louisiana, United States, 70130
      • Galderma Investigational Site (Site#8580)
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Galderma Investigational Site (Site#8783)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GP0116	Device: GP0116; GP0116 is an injectable, sterile, transparent product.
Active Comparator: FDA Approved Device	Device: Active Comparator: FDA approved dermal filler device; FDA approved dermal filler device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	At 3 months after Baseline

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Manifestations
• Other Study ID Numbers: 43N3US2204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No