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

Galderma R&D140 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

140

Conditions

Chin Retrusion Chin Augmentation

Interventions

Restylane DefyneDEVICE

hyaluronic acid dermal filler gel

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (11)

Westside Aesthetics

Los Angeles, California, United States

Ablon Skin Institute and Research Center

Manhattan Beach, California, United States

Marcus Facial Plastic Surgery

Redondo Beach, California, United States

Outcomes

Primary Outcomes

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

Time frame: 12 weeks after baseline

Secondary Outcomes

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).

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

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