NCT03967444已完成不适用
Post Marketing Study to Evaluate Lip Augmentation & Satisfaction With Restylane Kysse
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
- 59
- 试验地点
- 2
- 主要终点
- Assess Treatment With Restylane Kysse 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 Kysse.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Signed and dated informed consent to participate in the study
- •Adult women and men who intend to undergo lip 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 Kysse Using GAIS
时间窗: 8 weeks after last treatment
The 5-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the lips compared to pre-treatment. The rating is very much improved, much improved, improved, no change, or worse. Responders are those with a rating of at least improved.
次要结局
未报告次要终点
研究者
研究点 (2)
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