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NCT05987163 Clinical Trial

Study to Evaluate the Safety and Effectiveness of GP0116

Skin Manifestations Clinical Trial

— NLF  

Official title:
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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05987163
Other study ID # 43N3US2204
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 12, 2023
Est. completion date March 31, 2026

Study information
Verified date July 2023
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 186
Est. completion date March 31, 2026
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• GP0116
GP0116 is an injectable, sterile, transparent product.
• Active Comparator: FDA approved dermal filler device
FDA approved dermal filler device

Locations
Country Name City State
United States Galderma Investigational Site (Site#8783) Cincinnati Ohio
United States Galderma Investigational Site (Site#8580) New Orleans Louisiana
United States Galderma Investigational Site (Site#8126) West Palm Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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