NCT04080882已完成2 期
A Multicenter, Randomized, Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Moderate to Severe Platysmal Bands
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 80
- 试验地点
- 8
- 主要终点
- Responder Rate at Month 1 for a Single Dose of abobotulinumtoxinA Compared to Placebo
研究概览
简要总结
Interventional phase 2 study to evaluate safety and efficacy of abobotulinumtoxinA for the treatment of platysmal bands.
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 platysmal bands at maximum contraction as assessed by the Investigator using a photographic scale
- •Platysmal bands graded as Level 3 or 4 at maximum contraction as assessed by the subject using a photographic scale
排除标准
- •Botulinum toxin treatment of any serotype below the lower orbital rim, in the neck or chest within 12 months prior to study treatment
研究组 & 干预措施
AbobotulinumtoxinA dose 1
Active Comparator
AbobotulinumtoxinA dose 1 injected into platysma bands
干预措施: AbobotulinumtoxinA dose 1 (Biological)
placebo
Placebo Comparator
placebo injected into platysma bands
干预措施: Placebo (Other)
AbobotulinumtoxinA dose 2
Active Comparator
AbobotulinumtoxinA dose 2 injected into platysma bands
干预措施: AbobotulinumtoxinA dose 2 (Biological)
AbobotulinumtoxinA dose 3
Active Comparator
AbobotulinumtoxinA dose 3 injected into platysma bands
干预措施: AbobotulinumtoxinA dose 3 (Biological)
结局指标
主要结局
Responder Rate at Month 1 for a Single Dose of abobotulinumtoxinA Compared to Placebo
时间窗: Month 1 after treatment
A responder is defined as a subject who achieves grade 1 or 2 in platysmal band severity on the Investigator Live Assessment (ILA).
次要结局
未报告次要终点
研究者
研究点 (8)
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