Restylane Defyne for Correction of Chin Retrusion

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

Official Title
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A Randomized, Multi-center, Evaluator-blinded, No-treatment Controlled Study to Evaluate the Effectiveness and Safety of Restylane Defyne for Correction of Chin Retrusion

Conditions
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Chin Retrusion

Intervention / Treatment
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* Device: Restylane Defyne


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated informed consent to participate in the study. Men or women aged 18 years of age or older of Chinese origin. Subjects 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Single injection and optional touch-up injection with Restylane Defyne in chin | Device: Restylane Defyne<br>* Intradermal injection<br>|
| No Intervention: Control Group<br>No treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GCRS(Galderma Chin Retrusion Scale) at 6 months | 1 point improvement from baseline on the GCRS as measured by the Blinded Evaluator at 6 months (after last treatment in Treatment Group, and after randomization in Control Group) | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyaluronic acid, Chin Retrusion