GP0116 for Facial Wrinkles and Folds

(NLF Trial)

Recruiting at 18 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Galderma R&D

Disqualifiers: Allergies, Facial surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

186 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment GP0116 for facial wrinkles and folds?

Research shows that hyaluronic acid, a component often used in similar treatments, is effective in reducing facial wrinkles and folds. Studies on other treatments like polycaprolactone gel and growth factor concentrate also demonstrate significant improvements in facial wrinkles, suggesting that GP0116 may have similar benefits. ^{1 2 3 4 5}

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for men and women aged 22 or older who are not pregnant or breastfeeding, with moderate to severe dynamic facial wrinkles and folds. Participants must want treatment for both sides of their face but can't have had previous facial surgery near the area, allergies to hyaluronic acid gels or local anesthetics, or a history of severe allergic reactions.

Inclusion Criteria

I am a man or a woman not pregnant or breastfeeding, aged 22 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

I plan to get treatment for both of my nasal labial folds.

Exclusion Criteria

I have had surgery on my face near the area to be treated.

I am allergic to injectable hyaluronic acid products.

Known/previous allergy or hypersensitivity to local anesthetics

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GP0116 or a comparator control for correction of nasolabial folds

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• GP0116

Trial Overview The study tests GP0116, which is being compared to an FDA-approved dermal filler device. It's designed as a controlled test where participants are randomly assigned treatments in multiple centers. The goal is to see how well GP0116 works on reducing moderate to severe facial wrinkles and folds.

Participant Groups

Group I: GP0116 Experimental Treatment 1 Intervention

Group II: FDA Approved Device Active Control 1 Intervention

Who Is Running the Clinical Trial?

Galderma R&D

Lead Sponsor

Trials

303

Recruited

60,700+

Flemming Ørnskov

Galderma R&D

Chief Executive Officer since 2019

MD, MPH

Baldo Scassellati Sforzolini

Galderma R&D

Chief Medical Officer

MD, PhD

References

1. India pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Growth Factor Concentrate in the Treatment of Nasolabial Fold Correction: Split Face Pilot Study. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of small and large gel-particle hyaluronic acid in the correction of perioral wrinkles. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Polycaprolactone in Treating Nasolabial Folds: A Prospective, Multicenter, and Randomized Controlled Trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The Rejuvenating Effect and Tolerability of an Auto-Cross-Linked Hyaluronic Acid on Décolletage: A Pilot Prospective Study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effects of highly concentrated hyaluronic acid filler on nasolabial fold correction: A 24-month extension study. [2018]