A Study to Evaluate the Safety and Efficacy of Restylane Defyne for Chin Augmentation and Correction of Chin Retrusion

Study Overview
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Brief Summary
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To demonstrate the effectiveness of Restylane Defyne for chin augmentation and correction of chin retrusion by demonstrating the superiority in responder rates relative to no treatment.

Detailed Description
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This was a randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane Defyne in the chin for augmentation and correction of chin retrusion. This study was designed to enroll and randomize approximately 140 subjects in a 3:1 ratio of treatment to Restylane Defyne or no-treatment-control, including at least 21 subjects of Fitzpatrick skin type IV through VI. All randomized subjects were to have a Galderma Chin Retrusion Scale (GCRS) score of 1 (Mild) or 2 (Moderate). Eligible subjects randomized to receive treatment were injected by the Treating Investigator at Day 1. The method of injection was at the discretion of the Treating Investigator. A sufficient amount of product was injected to achieve optimal correction of the chin, in the opinion of the Treating Investigator and subject. Optimal appearance was defined as at least 1 GCRS grade improvement from baseline and the best correction that could be achieved as agreed by the Treating Investigator and the subject. At the 48-week visit, after all study procedures for the visit were completed, treated subjects had the option of receiving an additional treatment if optimal aesthetic improvement was not maintained with Restylane Defyne. Non-treated control subjects also had the option of receiving treatment with Restylane Defyne in the chin at Week 48. If an optional treatment was performed, a safety follow-up visits were scheduled

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

Conditions
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Chin Retrusion, Chin Augmentation

Intervention / Treatment
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* Device: Restylane Defyne


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects willing to comply with the requirements of the study and providing a signed written informed consent. Males or non-pregnant, non-breastfeeding females, 22 years of age or older, seeking chin augmentation or correction of retrusion Exclusion Criteria: Allergy of hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins Allergy or hypersensitivity to lidocaine or other amide-type anesthetics, or topical anesthetics or nerve blocking agents

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Restylane Defyne<br>injection with Restylane Defyne | Device: Restylane Defyne<br>* hyaluronic acid dermal filler gel<br>|
| No Intervention: Control<br>no-treatment control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate Effectiveness of the Treatment Using the Galderma Chin Restrusion Scale | subjects achieving at least 1-grade improvement from baseline using the Galderma Chin Retrusion Scale (GCRS; 0=no retrusion, 1=mild retrusion, 2=moderate retrusion, 3=substantial retrusion) as assessed by blinded evaluator | 12 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate Subject Satisfaction Using the FACE-Q (Baseline to Week 12) | Summary of change from Baseline to Week 12 in the FACE-Q Satisfaction with Chin, where subjects were asked about their satisfaction with treatment outcome on their chin. Higher scores reflect a better outcome. Scale consists of 10 questions and subjects select level of satisfaction for each question from/to Very dissatisfied = 1, Somewhat dissatisfied = 2, Somewhat satisfied = 3, Very satisfied = 4. A Conversion Table converts raw scale summed score into a score from 0 (worst) to 100 (best). If missing data is less than 50% of the scale's items, the mean of the completed items is used (Rasch Transformed Total Score: BOCF (ITT Population). | 12 weeks after last injection | 
| Evaluate Effectiveness of the Treatment Using the Galderma Chin Retrusion | Response rates, defined by at least 1 point improvement from baseline using the Galderma Chin Retrusion Scale (GCRS), as assessed by the Blinded Evaluator, at 24,36, and 48 weeks after the last injection for the treatment group or after baseline if randomized to no treatment | 24, 36, and 48 weeks after last injection | 
| Assess Overall Aesthetic Improvement Using the Global Aesthetic Improvement Scale | Aesthetic improvement (overall appearance) after treatment with Restylane® Defyne compared to no-treatment control, as determined by assessments using the Global Aesthetic Improvement Scale (GAIS). Assessments were performed at 12, 24, 36, and 48 weeks after treatment. Treating Investigators and subjects separately rated aesthetic improvement of the chin from baseline appearance, where a higher score reflects reporting of greater improvement. The subjects and Investigators select a score from the following categorical scale: Very much improved = 3; Much improved = 2; Improved = 1; No change = 0; Worse = -1; Much worse = -2; Very much worse = -3. Scores range from -3 (worst) to 3 (best). Higher scores reflect a better outcome. The Responder Rate is defined as the number and percent of subjects with a rating of at least Improved based off of subject's/investigator's (as appropriate) assessment of the GAIS. | 12, 24, 36, and 48 weeks after last injection | 
| Evaluate Subject Satisfaction Using the FACE-Q (From Baseline to Week 24) | Summary of Change from Baseline to Week 24 in FACE-Q Satisfaction with Chin, where subjects were asked about their satisfaction with treatment outcome on their chin. Higher scores reflect a better outcome. Scale consists of 10 questions and subjects select level of satisfaction for each question from/to Very dissatisfied = 1, Somewhat dissatisfied = 2, Somewhat satisfied = 3, Very satisfied = 4. A Conversion Table converts raw scale summed score into a score from 0 (worst) to 100 (best). IIf missing data is less than 50% of the scale's items, the mean of the completed items is used (Rasch Transformed Total Score: BOCF (ITT Population). | 24, 36, and 48 weeks after last injection | 
| Evaluate Volume Change in the Treated Area Using 3D Imaging | Summary of Total Volume Change in the Chin Area Measured by Digital 3D Photography at Each Visit (ITT Population). Total volume change corresponds to net volume change from baseline in the chin area. | 12, 24, 36, and 48 weeks after last injection |