NCT05148000已完成3 期
Open-label Study to Assess Aesthetic Improvement Following Treatment With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Responders in QM1114-DP versus Placebo using the Global Aesthetic Improvement Scale (GAIS) at maximum frown at Month 1
研究概览
简要总结
This study to assess aesthetic improvement following treatment with QM1114-DP.
详细描述
This was an open-label, single-center multi-center study to assess aesthetic improvement in the Glabellar and Lateral Canthal regions following treatment with QM1114-DP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or Female 18 years or older
- •Moderate to severe bilaterally symmetrical LCL as assessed by the investigator
- •Moderate to severe GL at maximum frown as assessed by the Investigator
排除标准
- •Previous use of any botulinum toxin in facial areas within 9 months prior to study treatment
- •Female who was pregnant, breast feeding or intended to conceive a child during the study.
- •Known allergy to hypersensitivity or any component of the Investigational product
研究组 & 干预措施
QM1114-DP
Experimental
QM1114-DP
干预措施: QM1114-DP (Biological)
结局指标
主要结局
Responders in QM1114-DP versus Placebo using the Global Aesthetic Improvement Scale (GAIS) at maximum frown at Month 1
时间窗: 1 month
Responder Rate is defined as a subject who responds at least Improved on the GAIS at maximum frown
Responders in QM1114-DP versus Placebo using the Global Aesthetic Improvement Scale (GAIS) at maximum smile at Month 1
时间窗: 1 month
Responder Rate is defined as a subject who responds at least Improved on the GAIS at maximum smile
次要结局
未报告次要终点
研究者
研究点 (1)
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