NCT04631263已完成不适用
A Randomized, Evaluator-blinded, Parallel Group, no Treatment Controlled, Multi-center Study to Evaluate Effectiveness and Safety of GP0109 for Augmentation and Correction of Retrusion in the Chin Region
适应症
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
- 10
- 主要终点
- Responder rate based on the Galderma Chin Retrusion Scale as assessed live by the Blinded Evaluator
研究概览
简要总结
Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GP0109 for augmentation and correction or retrusion in the chin region in Canada
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subject willing to comply with the requirements of the study
- •subject intent to receive treatment for augmentation and correction of retrusion in the chin region
- •subject with mild or moderate (grade 1 or 2) on the GCRS
排除标准
- •subjects presenting with know allergy to HA (hyaluronic acid) filler or amide local anesthetics
- •subjects with any previous facial surgery below the nasal line or previous HA filler or collagen below the nasal line within 12 months
- •subjects in any other interventional clinical study within 30 days before baseline
结局指标
主要结局
Responder rate based on the Galderma Chin Retrusion Scale as assessed live by the Blinded Evaluator
时间窗: 3 months after baseline
次要结局
未报告次要终点
研究者
研究点 (10)
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