NCT03960957已完成3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 301
- 试验地点
- 12
- 主要终点
- Evaluate Composite Responder Rate at Month 1 for a Single Dose of AbobotulinumtoxinA Compared to Placebo
研究概览
简要总结
An interventional phase 3 study to evaluate efficacy and safety of a new dilution and injection volume of AbobotulinumtoxinA treatment for glabellar lines
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, 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
- •Understands the study requirements and signs an informed consent form
排除标准
- •Botulinum toxin treatment in the face within 6 months prior to study treatment
结局指标
主要结局
Evaluate Composite Responder Rate at Month 1 for a Single Dose of AbobotulinumtoxinA Compared to Placebo
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 grades 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 (12)
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