CompletedNot Applicable

Restylane Defyne Compared to Restylane for Correction of Moderate to Severe Nasolabial Folds

China175 participantsStarted 2017-01-16

Plain-language summary

This is a randomized, split face, multicenter study to evaluate the efficacy and safety of Restylane Defyne compared to Restylane in correction of NLFs.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed informed consent.
✓. Men or women aged 18 years of age or older of Chinese origin.
✓. Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study.
✓. Intent to undergo correction of both NLFs with a wrinkle severity in WSRS of either 3 on both sides or 4 on both sides, as assessed by the blinded evaluator.

Exclusion criteria

✕. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) Gel and/or local anesthetics, e.g., lidocaine or other amide-type anesthetics.
✕. Previous tissue revitalization treatment below the level of the lower orbital rim within 6 months before treatment.
✕. Previous surgery or tattoo in the area to be treated.
✕. Previous tissue augmentation therapy or contouring with any permanent (nonbiodegradable) or semi-permanent facial tissue augmentation therapy or autologous fat or permanent implant below the level of the lower orbital rim.
✕. Previous use of neurotoxins or any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months before treatment.
✕. Scars or deformities, active skin disease, inflammation or related conditions such as infection, perioral dermatitis, seborrheic dermatitis, eczema, rosacea, acne, psoriasis, and herpes zoster near or in the area to be treated.
✕. Other condition preventing the subject from entering the study in the Investigator's opinion

What they're measuring

Percentage of Responders, Defined by at Least 1-point Improvement From Baseline on the WSRS.

Timeframe: 6 month

Trial details

NCT IDNCT03003130

SponsorGalderma R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-03-30

Results submitted2020-11-04

View on ClinicalTrials.gov More Nasolabial Folds in Chinese Population trials