NCT00408785已完成3 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of BOTOX? (Botulinum Toxin Type A) in Subjects With Glabellar Lines
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- The investigator's rating of Glabellar line severity at maximum frown
研究概览
简要总结
This is a Multicenter, double-blind, randomized, placebo-controlled, parallel-group comparative study to confirm the efficacy and safety of BOTOX 20 units single injection for the Chinese patients with glabellar lines. The subjects will receive a single intramuscular treatment consisting of 5 injections of either BOTOX? 20U or placebo.
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A
Experimental
Injection
干预措施: Botulinum Toxin Type A (Drug)
B
Placebo Comparator
Injection
干预措施: sodium chloride (Drug)
结局指标
主要结局
The investigator's rating of Glabellar line severity at maximum frown
时间窗: Day 30 after injection
次要结局
- Investigator's rating of Glabellar line severity at rest, subject's global assessment of change in appearance of glabellar lines, the subject's perception of age and safety evaluations.(Day 7, 30, 60, 90, 120 after injection)
研究者
研究点 (1)
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