WrinkleNCT06351293
A Comparative Analysis of Two Hyaluronic Acid Fillers for Nasolabial Fold Correction
A study testing Defyne Treatment in Nasolabial Fold and RHA3 Treatment in Nasolabial Fold in people with Wrinkle, run by Galderma R&D at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- Defyne Treatment in Nasolabial Fold and RHA3 Treatment in Nasolabial Fold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.)
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- 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.
Who cannot join
- 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.
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- 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.
- Planning on having surgeries and/or invasive medical procedures during the course of the study.
- Treatment with chemotherapy, immunosuppressive agents, inhaled corticosteroids, immunomodulatory therapy (e.g., monoclonal antibodies or antiviral treatment for human immunodeficiency virus or hepatitis C) within 3 months prior to the baseline visit.
- Subjects with history of cancer or previous radiation near or on the NLF region.
- Human immunodeficiency virus positive or active hepatitis.
- Subjects with any diseases, condition or presentation that may, in the opinion of the investigator, may put the subject at risk, may confound study results, or may interfere with participation in the study.
- Study site personnel, close relatives of the study site personnel (e.g., parents, children, siblings, or spouse), or employees and close relatives of employees at the Sponsor company.
- Subjects who have participated in any interventional study within 30 days of enrollment, or subjects planning to participate in any other interventional clinical research study while enrolled in this trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Aesthetic Clinique
Santa Rosa Beach, Florida, 32459
About this study
Official title: A Randomized, Split-face Clinical Study on Comparative Analysis of Two Hyaluronic Acid Fillers for Nasolabial Fold Correction
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
- Being tested
- Defyne Treatment in Nasolabial Fold, RHA3 Treatment in Nasolabial Fold
- Keywords
- Nasolabial fold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defyne Treatment in Nasolabial FoldDevice
Defyne will be injected into left or right nasolabial fold, per randomization.
RHA3 Treatment in Nasolabial FoldDevice
RHA3 will be injected into left or right nasolabial fold, per randomization.
| Study group | Role | What they receive |
|---|---|---|
| Defyne Treatment | Experimental | Defyne will be injected into the left or right nasolabial fold, per randomization. Receives: Device: Defyne Treatment in Nasolabial Fold |
| RHA3 Treatment | Active comparator | RHA3 will be injected into the left or right nasolabial fold, per randomization. Receives: Device: RHA3 Treatment in Nasolabial Fold |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4, Month 3, Month 6, Month 12
Secondary outcomes (1)
Volume Change Imaging Analysis
Digital images of the subject's face will be taken of subject's face with a neutral expression and open-mouth maximum smiling expression. These images will be analyzed by VISIA-CRP software for nasolabial fold volume change compared to baseline. A decrease in scores indicates an improvement.
Measured: Baseline, Week 4, Month 3, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start21 Feb 2024
- Primary completion17 Mar 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Weiner, MD, Principal investigator, The Aesthetic Clinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351293
- Sponsor's protocol ID
- GLI.04.US.SL.034
- Status last verified
- Oct 2024
- First submitted
- 20 Mar 2024
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Split-face Clinical Study on Comparative Analysis of Two Hyaluronic Acid Fillers for Nasolabial Fold Correction
- ClinicalTrials.gov ID
- NCT06351293
- Acronym / sponsor ID
- GLI.04.US.SL.034
- Conditions
- Wrinkle
- Keywords
- Nasolabial fold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Defyne Treatment | Experimental | Device: Defyne Treatment in Nasolabial FoldDefyne will be injected into the left or right nasolabial fold, per randomization. |
| RHA3 Treatment | Active comparator | Device: RHA3 Treatment in Nasolabial FoldRHA3 will be injected into the left or right nasolabial fold, per randomization. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Defyne Treatment in Nasolabial FoldDefyne will be injected into left or right nasolabial fold, per randomization. | Device | Defyne Treatment |
| RHA3 Treatment in Nasolabial FoldRHA3 will be injected into left or right nasolabial fold, per randomization. | Device | RHA3 Treatment |
Primary outcome
Visual Comparison of Nasolabial Fold Ultrasounds
Time frame: Baseline, Week 4, Month 3, Month 6, Month 12
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.
1 secondary outcome
Volume Change Imaging Analysis
Time frame: Baseline, Week 4, Month 3, Month 6, Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Weiner, MD principal investigator
The Aesthetic Clinique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Defyne Treatment in Nasolabial Fold and RHA3 Treatment in Nasolabial Fold in people with Wrinkle, run by Galderma R&D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Comparison of Nasolabial Fold Ultrasounds (time frame: Baseline, Week 4, Month 3, Month 6, Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.