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Filler Face-Off: which injectable smooths smile lines best?

NCT ID NCT06351293

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared two hyaluronic acid fillers, Defyne and RHA3, for treating nasolabial folds (smile lines) in 15 adults aged 22 to 65. Each participant received one filler on each side of their face, with an optional touch-up after 4 weeks. Researchers used ultrasound and 3D imaging to measure filler placement and volume changes over 12 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

15 people

The number who actually took part.

Started

Feb 2024

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects 22 to 65 years of age. 2. 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. 3. Adult subjects of any gender, race, ethnicity, Fitzpatrick skin type, and sexual orientation. 4. Subjects with general good health. 5. Subjects who are willing to abstain from any other facial plastic surgical or cosmetic procedure(s) during the duration of the study. 6. 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.) 7. 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. 8. Subjects who agree to be photographed at each visit. 9. 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. Exclusion Criteria: 1. Pregnant, breastfeeding, or planning pregnancy during the course of the study. 2. 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). 3. Subjects with history of allergy or hypersensitivity to lidocaine and/or injectable HA. 4. Subjects with previous facial surgery, including aesthetic facial surgical therapy, liposuction, or tattoo in the treatment area. 5. Subjects with previous permanent or semi-permanent implant in proposed treatment area. 6. Subjects with previous biodegradable tissue augmentation therapy in the proposed treatment area within 12 months prior to the baseline visit. 7. Subjects with previous tissue revitalization treatment with neurotoxin in the facial area within 6 months prior to the baseline visit. 8. 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). 9. Presence of any disease, lesions, or sign near or on the NLF region, e.g., 1. Inflammation, active, or chronic infection in or near the treatment area 2. Psoriasis, eczema, rosacea, atopic dermatitis, herpes zoster/herpes simplex, and acanthosis 3. Scars or deformities 4. Beard or facial hair 10. 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. 11. Subjects with tendency to form keloids, hypertrophic scars, or any other healing disorder. 12. Planning on having surgeries and/or invasive medical procedures during the course of the study. 13. 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. 14. Subjects with history of cancer or previous radiation near or on the NLF region. 15. Human immunodeficiency virus positive or active hepatitis. 16. 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. 17. 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. 18. 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • The Aesthetic Clinique

    Santa Rosa Beach, Florida, 32459, United States

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