Restylane Defyne for Correction of Chin Retrusion

Galderma

Status: Completed

Conditions: Chin Retrusion

Treatments: Device: Restylane Defyne

Study type: Interventional

Funder types: Industry

Identifiers

NCT03597256

43CH1627

Details and patient eligibility

About

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

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid gel.
2. Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
3. History of severe or multiple allergies, manifested by anaphylaxis.
4. 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.
5. Previous surgery (including aesthetic facial surgical therapy or liposuction), piercing or tattoo in the area to be treated.
6. 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.
7. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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148 participants in 2 patient groups

Treatment Group

Experimental group

Description:

Single injection and optional touch-up injection with Restylane Defyne in chin

Treatment:

Device: Restylane Defyne

Control Group

No Intervention group

Description:

No treatment