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Active, Not Recruiting

NCT Number: NCT05987163

Study to Evaluate the Safety and Effectiveness of GP0116

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Skin Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Galderma Investigational Site (Site#8784), San Juan, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GP0116

Device

GP0116 is an injectable, sterile, transparent product.

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

Device

FDA approved dermal filler device (RHA 3)

Primary outcomes

  1. To demonstrate non-inferiority of GP0116 versus a comparator control

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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.

Acronym: NLF

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Aug 14, 2023
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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