A Comparative Analysis of Two Hyaluronic Acid Fillers for Nasolabial Fold Correction

NCT06351293 | Completed FDA Device

• 1 other identifier: GLI.04.US.SL.034
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wrinkle

Keywords

Nasolabial fold

Outcome Measures

Primary Outcomes (1)

• Visual Comparison of Nasolabial Fold Ultrasounds

  A single ultrasound assessment will be taken on each subject's left and right NLF, at neutral expression and at maximum smiling, in photo and video format. The placement of the ultrasound probe will be on the NLF, at the half-way point between nasal ala and oral commissure. Ultrasound assessments will be performed using an 18 MHz GE Venue Fit, a 20 MHz GE, and a 70 MHz Vevo MD ultrasonic transducer interfaced to a system. The probe will have a standard setting of gain, depth, and velocity scale to qualitatively assess placement/depth of filler, size of filler aggregates, and artery in NLF.

  Baseline, Week 4, Month 3, Month 6, Month 12

Secondary Outcomes (1)

• Volume Change Imaging Analysis

  Baseline, Week 4, Month 3, Month 6, Month 12

Study Arms (2)

Defyne Treatment

EXPERIMENTAL

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

Device: Defyne Treatment in Nasolabial Fold

RHA3 Treatment

ACTIVE COMPARATOR

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

Device: RHA3 Treatment in Nasolabial Fold

Interventions

Defyne Treatment in Nasolabial Fold DEVICE

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

Defyne Treatment

RHA3 Treatment in Nasolabial Fold DEVICE

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

RHA3 Treatment

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 22 to 65 years of age.
• Subjects with moderate-to-severe NLF based on the 5-point Wrinkle Severity Rating Scale (WSRS), and in the opinion of the investigator, is otherwise a good candidate for treatment with HA fillers.
• Adult subjects of any gender, race, ethnicity, Fitzpatrick skin type, and sexual orientation.
• Subjects with general good health.
• Subjects who are willing to abstain from any other facial plastic surgical or cosmetic procedure(s) during the duration of the study.
• For female subjects of childbearing potential, she must not be pregnant, breastfeeding or planning pregnancy during the course of the study. Subjects must be willing to take a urine pregnancy test (UPT) prior to all treatments. (Females of non-childbearing potential, e.g., post-menopausal (absence of menstrual bleeding for 1 year without any other medical reason), hysterectomy, or bilateral ovariectomy, are not required to have a UPT.)
• Subjects who are able and willing to consent to the study informed consent form (ICF), Health Insurance Portability and Accountability Act of 1996 (HIPAA), and photography form prior to any study related procedures.
• Subjects who agree to be photographed at each visit.
• Subjects who agree to adhere to the procedures and requirements of the study, to report to the institute on the day(s) and at the time(s) scheduled for the assessments, and to complete all required visits.

You may not qualify if:

• Pregnant, breastfeeding, or planning pregnancy during the course of the study.
• Current smokers or consumer of nicotine (e.g., cigarettes, e-cigarettes, vaping device with pre-filled pods, vapor tank or mod, chewing tobacco, nicotine replacement therapy).
• Subjects with history of allergy or hypersensitivity to lidocaine and/or injectable HA.
• Subjects with previous facial surgery, including aesthetic facial surgical therapy, liposuction, or tattoo in the treatment area.
• Subjects with previous permanent or semi-permanent implant in proposed treatment area.
• Subjects with previous biodegradable tissue augmentation therapy in the proposed treatment area within 12 months prior to the baseline visit.
• Subjects with previous tissue revitalization treatment with neurotoxin in the facial area within 6 months prior to the baseline visit.
• Subjects with history of other facial treatment/procedure at the study area (NLF) in the previous 6 months that would potentially interfere with study injections (e.g., oral surgery, laser or light therapy, chemical peeling, resurfacing, mesotherapy, dermabrasion).
• Presence of any disease, lesions, or sign near or on the NLF region, e.g.,
• Inflammation, active, or chronic infection in or near the treatment area
• Psoriasis, eczema, rosacea, atopic dermatitis, herpes zoster/herpes simplex, and acanthosis
• Scars or deformities
• Beard or facial hair
• Subjects with history of bleeding disorders or treatment with anticoagulants or inhibitors of platelet aggregation (e.g., aspirin or other non-steroidal anti-inflammatory drugs), omega 3, or vitamin E within 14 days before treatment. Omega 3 and vitamin E are acceptable only as part of a standard multivitamin formulation.
• Subjects with tendency to form keloids, hypertrophic scars, or any other healing disorder.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

The Aesthetic Clinique

Santa Rosa Beach, Florida, 32459, United States

Location

Study Officials

• Steven Weiner, MD

  The Aesthetic Clinique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be blinded to the treatment assignment, in which randomization and treatment side will be concealed in order to avoid bias in subjective assessment. The clinic staff will mask the product identity by covering the packaging and product name (e.g., using tape, marker, wipe-out, etc.) so that it is not visible to the subjects. The Investigator will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 8, 2024
• Study Start: February 21, 2024
• Primary Completion: March 17, 2025
• Study Completion: April 30, 2025
• Last Updated: January 16, 2026

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)