A Comparative Analysis of Two Hyaluronic Acid Fillers for Nasolabial Fold Correction (NCT06351293) | Clinical Trial Compass
CompletedNot Applicable
A Comparative Analysis of Two Hyaluronic Acid Fillers for Nasolabial Fold Correction
United States15 participantsStarted 2024-02-21
Plain-language 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.
Who can participate
Age range22 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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).