NCT01940991已完成2 期
Efficacy and Safety of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Composite endpoint
研究概览
简要总结
This study will confirm the efficacy and safety of a single topical administration of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet 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
- 否
入选标准
- •Moderate to severe crow's feet lines
- •Female or male, 18 to 65 years of age and in good general health
- •Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study
排除标准
- •Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A
- •Muscle weakness or paralysis, particularly in the area receiving study treatment
- •Active skin disease or irritation at the treatment area
- •Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart
- •Treatment with Botulinum Toxin Type A for crow's feet lines in the last 6 months or 3 months anywhere in the body
研究组 & 干预措施
Dose B
Placebo Comparator
Dose B: Placebo
干预措施: Placebo (Drug)
Dose A
Experimental
Dose A: Botulinum Toxin Type A
干预措施: Botulinum Toxin Type A (Drug)
结局指标
主要结局
Composite endpoint
时间窗: Week 4
Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines
次要结局
- Investigator Global Assessment with 2 points or greater improvement from baseline(Week 4)
- Investigator Global Assessment with 1 point or greater improvement from baseline(Week 4)
- Patient Severity Assessment with 2 points or greater improvement from baseline(Week 4)
研究者
研究点 (1)
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