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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 140
- 试验地点
- 21
- 主要终点
- Evaluate Effectiveness of the Treatment Using the Galderma Chin Restrusion Scale
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Evaluate Effectiveness of the Treatment Using the Galderma Chin Restrusion Scale
时间窗: 12 weeks after baseline
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
次要结局
- Evaluate Effectiveness of the Treatment Using the Galderma Chin Retrusion(24, 36, and 48 weeks after last injection)
- Assess Overall Aesthetic Improvement Using the Global Aesthetic Improvement Scale(12, 24, 36, and 48 weeks after last injection)
- Evaluate Subject Satisfaction Using the FACE-Q (Baseline to Week 12)(12 weeks after last injection)
- Evaluate Volume Change in the Treated Area Using 3D Imaging(12, 24, 36, and 48 weeks after last injection)
- Evaluate Subject Satisfaction Using the FACE-Q (From Baseline to Week 24)(24, 36, and 48 weeks after last injection)