Hyaluronic Acid Fillers for Wrinkles

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Galderma R&D

Must not be taking: Anticoagulants, Immunosuppressants, Corticosteroids, others

Disqualifiers: Pregnancy, Smoking, Cancer, HIV, others

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

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a randomized, split-face, subject-blinded, comparative study. Subjects will receive initial treatment with Defyne on one of the NLFs and with RHA3 on the other based on the pre-determined randomization. 4 weeks after the initial treatment, subjects will receive optional touch-up on one side or both sides at the Investigator's discretion for optimal correction. Subjects to return to the site at Month 3, 6, and 12 for follow-ups.

Research Team

Steven Weiner, MD

Principal Investigator

The Aesthetic Clinique

Eligibility Criteria

This trial is for adults aged 22-65 with moderate-to-severe nasolabial fold wrinkles. Candidates must be in good health, not pregnant or breastfeeding, and willing to avoid other facial procedures during the study. Smokers and those with allergies to lidocaine or HA fillers are excluded.

Inclusion Criteria

I am between 22 and 65 years old.

I agree not to have any facial cosmetic procedures during the study.

Subjects in general good health

Exclusion Criteria

I have a history of bleeding, keloids, or healing disorders.

Pregnant, breastfeeding, or planning pregnancy during the study

Current smokers or consumers of nicotine

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Initial treatment with Defyne on one NLF and RHA3 on the other, based on randomization

4 weeks

1 visit (in-person)

Touch-up

Optional touch-up treatment on one or both sides at the Investigator's discretion

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

3 visits (in-person) at Month 3, 6, and 12

Treatment Details

Interventions

• Defyne
• RHA3

Trial Overview The study compares two hyaluronic acid fillers: Defyne and RHA3 for correcting nasolabial folds. Participants will receive both treatments on different sides of their face randomly and have follow-ups at months 3, 6, and 12 after initial treatment.

Participant Groups

Group I: Defyne Treatment Experimental Treatment 1 Intervention

Defyne will be injected into the left or right nasolabial fold, per randomization.

Group II: RHA3 Treatment Active Control 1 Intervention

RHA3 will be injected into the left or right nasolabial fold, per randomization.

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