NCT03736928已完成2 期
A Multicenter, Randomized, Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 401
- 试验地点
- 11
- 主要终点
- Number of Composite Responders at Month 1
研究概览
简要总结
An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA treatment for glabellar lines
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Moderate to severe glabellar lines at maximum frown as assessed by the Investigator using a photographic scale
- •Moderate to severe glabellar lines at maximum frown as assessed by the subject using a static categorical scale
排除标准
- •Botulinum toxin treatment in the face within 9 months prior to study treatment
结局指标
主要结局
Number of Composite Responders at Month 1
时间窗: Month 1 after treatment
composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grade improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA)
次要结局
未报告次要终点
研究者
研究点 (11)
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