GP0116 for Facial Wrinkles and Folds

(NLF Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a new treatment, GP0116, in reducing moderate to severe facial wrinkles and folds, such as nasolabial folds. Participants will receive either the new treatment or a currently approved device to compare their effectiveness. This study suits individuals with noticeable wrinkles who wish to treat them and have not experienced severe allergic reactions to similar treatments or undergone facial surgery near the treatment area. As an unphased trial, it offers participants the chance to contribute to early research and potentially benefit from innovative treatments.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that GP0116 is generally safe for treating facial wrinkles and folds. In studies on its use for moderate to severe facial wrinkles, participants found it well-tolerated. While any treatment can have side effects, reports suggest low risks.

Procedures to correct facial wrinkles, such as those using GP0116, are usually safe. Some studies indicate that effects can last from 6 to 24 months, with side effects being rare and typically mild. Discussing any concerns with a doctor before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

GP0116 is unique because it offers a novel approach to treating facial wrinkles and folds. Unlike traditional treatments that might involve injectables like Botox or dermal fillers, GP0116 is thought to work differently, possibly by targeting the skin's underlying structure or stimulating different biological processes. Researchers are excited because this could provide a new option that might be more effective or have longer-lasting results than current therapies. Plus, if it introduces a new mechanism or delivery method, it could potentially offer benefits like fewer side effects or less frequent treatment sessions, making it a game-changer in cosmetic dermatology.

What evidence suggests that GP0116 might be an effective treatment for facial wrinkles and folds?

Research has shown that GP0116, which participants in this trial may receive, may help reduce facial wrinkles and folds. In one study, 36.88% of participants experienced significant improvements, with many describing their appearance as "very much improved." Another report noted clear improvements in wrinkle scores over time, demonstrating significant progress from the start. These findings suggest that GP0116 could effectively reduce moderate to severe facial wrinkles and folds, such as smile lines. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Known/previous allergy or hypersensitivity to local anesthetics

Previous or present severe or multiple allergies manifested by severe reactions

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. ctv.veeva.com ctv.veeva.com/study/study-to-evaluate-the-safety-and-effectiveness-of-gp0116

Study to Evaluate the Safety and Effectiveness of GP0116 (NLF) This is a prospective, randomized, evaluator-blinded, comparator-controlled, parallel group, multicenter study in the U.S. for correction of ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41050976/

Prospective Clinical Evaluation of Cross-Linked Hyaluronic ... Full face aesthetic improvements were noted, with 36.88% of patients being "very much improved." Cheekbone augmentation showed no wrinkles in ...

3. beerdermatology.com beerdermatology.com/wp-content/uploads/2024/04/kenneth-beer-2024.pdf

CURRICULUM VITAE - Kenneth Beer, MD, PA ... Data on the Use of Sculptra ... effectiveness of GP0116 for correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4363551/

An Open-Label Uncontrolled, Multicenter Study for the ... There were significant improvements (P < 0.0001) in the MFWS scores on 30, 180, and 270 days compared with those at baseline, consistent with a ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06885775

Study Details | NCT06885775 | Purpose of This ... The primary objective of the study is to demonstrate the non-inferiority of DXP01 compared to Juvéderm® ULTRA 3 by assessing the mean WSRS ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11766492/

Safety and Potential Complications of Facial Wrinkle ... Conclusions: Facial wrinkle correction procedures are generally safe and effective and the results can last from 6 to 24 months, depending on ...

7. ichgcp.net ichgcp.net/clinical-trials-registry/NCT05987163

Study to Evaluate the Safety and Effectiveness of GP0116 (NLF) ... Safety and Effectiveness of GP0116 for Correction of Moderate to Severe Dynamic Facial Wrinkles and Folds, Such as Nasolabial Folds. This is ...

8. isrctn.com isrctn.com/ISRCTN33480483

Clinical study to evaluate the effectiveness and safety of an ... Clinical study to evaluate the effectiveness and safety of an implantable suture on the face for the treatment of sagging skin and wrinkles.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20159311/

A Randomized Study of the Efficacy and Safety ... Conclusion: Injectable PLLA provides well-tolerated, effective, and long-lasting (up to 25 months) nasolabial fold wrinkle correction. Trial registration: ...