CompletedNot Applicable

Restylane Defyne for Correction of Chin Retrusion

China148 participantsStarted 2018-10-08

Plain-language summary

This is a randomized, evaluator-blinded, no-treatment controlled study in subjects with Chin Retrusion.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Participated with signed and dated informed consent form.
✓. Men or women aged 18 years of age or older of Chinese origin.
✓. Subjects who were seeking augmentation therapy for chin retrusion.
✓. GCRS score of 1 or 2 as assessed by the Blinded Evaluator

Exclusion criteria

✕. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid gel.
✕. Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
✕. History of severe or multiple allergies, manifested by anaphylaxis.
✕. Previous facial surgery, or tissue revitalization treatment with laser or light, needling, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling or dermabrasion below the level of the horizontal line from subnasale within 6 months before treatment.
✕. Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated.
✕. Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the horizontal line from subnasale.
✕. Other condition that was preventing the subject from entering the study in the Investigator's opinion, e.g. subjects not likely to avoid other facial cosmetic treatments, subjects anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result.

What they're measuring

Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS, as Assessed by the Blinded Evaluator at Month 6 ([Baseline Observation Carried Forward] BOCF Method)

Timeframe: At Month 6

Trial details

NCT IDNCT03597256

SponsorGalderma R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-09-24

Results submitted2022-10-10

View on ClinicalTrials.gov More Chin Retrusion trials