NCT06428253已完成3 期
A Single Center, Subject & Evaluator-blind, Randomized, Matched Pairs, Active-controlled, Confirmatory Study to Evlualte the Efficacy and Safety of HMM1-022 in Temporary Correction of Crow's Feet
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 2
- 主要终点
- Improvement rate of IGA-LCL wrinkle severity by external independent evaluators
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of HMM1-022 with Rejuran to improve Crow's feet
详细描述
A single center, subject & evaluator-blind, randomized, matched pairs, active-controlled, confirmatory study to evaluate the efficacy and safety of HMM1-022 in temporary correction of Crow's feet
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
- Double (Participant, Outcomes Assessor)
盲法说明
subject/evaluator blinding
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Improvement rate of IGA-LCL wrinkle severity by external independent evaluators
时间窗: 18 weeks
Improvement rate of 1 point or more on the crow's feet at rest IGA-LCL severity scale by external independent evaluators at 18 weeks after initial injection
次要结局
- Improvement rate of IGA-LCL wrinkle severity by external independent evaluators(8, 10 weeks)
- Change in GAIS scores assessed by an independent evaluator(8, 10, 18 weeks)
- Improvement rate of GAIS for both crow's feet as assessed by an independent evaluator(8, 10, 18 weeks)
- Change in GAIS scores assessed by the subject(8, 10, 18 weeks)
- Improvement rate of GAIS for both crow's feet as assessed by the subject(8, 10, 18 weeks)
研究者
研究点 (2)
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