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Dermal Filler

GP0116 for Facial Wrinkles and Folds (NLF Trial)

N/A
Waitlist Available
Research Sponsored by Galderma R&D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 months after baseline
Awards & highlights

NLF Trial Summary

This trial tests a new treatment for wrinkles and folds in the face. It's a comparison study in the US with blinded evaluators.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, common side effects from similar dermal fillers include swelling, redness at the injection site, pain or tenderness, firmness under the skin, lumps/bumps, bruising, itching and discoloration.

NLF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 months after baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 months after baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To demonstrate non-inferiority of GP0116 versus a comparator control

NLF Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: GP0116Experimental Treatment1 Intervention
Group II: FDA Approved DeviceActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Galderma R&DLead Sponsor
298 Previous Clinical Trials
60,144 Total Patients Enrolled
4 Trials studying Skin Manifestations
301 Patients Enrolled for Skin Manifestations

Media Library

GP0116 (Dermal Filler) Clinical Trial Eligibility Overview. Trial Name: NCT05987163 — N/A
Skin Manifestations Research Study Groups: FDA Approved Device, GP0116
Skin Manifestations Clinical Trial 2023: GP0116 Highlights & Side Effects. Trial Name: NCT05987163 — N/A
GP0116 (Dermal Filler) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05987163 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any availabilities for participation in this research endeavor?

"Reports from clinicaltrials.gov suggest that this particular study has already fulfilled its recruitment needs, with the first posting being on April 12th 2023 and the most recent update made on August 9th 2023. Fortunately, there are two other trials in progress for which enrolment is still possible."

Answered by AI

Who else is applying?

What site did they apply to?
Galderma Investigational Site (Site#8126)
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I want to be my best self. I want to age gracefully and beautifully.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Safety and Effectiveness of GP0116
2023. "Study to Evaluate the Safety and Effectiveness of GP0116". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05987163.
~62 spots leftby Oct 2024
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