NCT04638816已完成不适用
A Study Comparing Hyaluronic Acid Effectiveness & Evaluating Cheek Results With Restylane
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
- 60
- 试验地点
- 3
- 主要终点
- Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS
研究概览
简要总结
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Restylane
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signed and dated informed consent to participate in the study
- •Adult women who intend to undergo cheek augmentation
排除标准
- •Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics
- •Subjects with a previous implant other than HA in or near the intended treatment site
- •Participation in any other clinical study within three (3) months before treatment
结局指标
主要结局
Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS
时间窗: 4 weeks after last treatment, up to 6 weeks
The 7-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the treatment area (cheeks) compared to pre-treatment. The rating is very much improved, much improved, improved, no change, worse, much worse, or very much worse.
次要结局
未报告次要终点
研究者
研究点 (3)
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