NCT01951742已完成2 期
Dose Finding Study of Botulinum Neurotoxin Type A In Subjects With Crow's Feet (Lateral Canthal Lines)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 10
- 主要终点
- Investigators Global Assessment Scale
研究概览
简要总结
The purpose of this study is to establish the therapeutic range of ANT-1401 in the treatment of Crow's Feet.
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •30 - 60 years of age
- •mild to moderate Crow's Feet wrinkles at rest
- •moderate to severe Crow's Feet wrinkles on contraction
- •willingness to refrain from any product affecting skin remodeling
- •female subjects must be not pregnant and non-lactating
排除标准
- •history of peri-ocular surgery, brow lift or related procedures
- •procedures affecting the lateral canthal region in the prior 12 months
- •application of topical prescription medication to the treatment area
- •female subjects who are pregnant or are nursing a child
研究组 & 干预措施
Vehicle
Placebo Comparator
vehicle without ANT-1401
干预措施: Vehicle (Biological)
Dose 5
Experimental
highest dose
干预措施: ANT-1401 (Biological)
Dose 4
Experimental
second highest dose
干预措施: ANT-1401 (Biological)
Dose 3
Experimental
mid-level dose
干预措施: ANT-1401 (Biological)
Dose 2
Experimental
second lowest dose
干预措施: ANT-1401 (Biological)
Dose 1
Experimental
lowest dose
干预措施: ANT-1401 (Biological)
结局指标
主要结局
Investigators Global Assessment Scale
时间窗: Week 4
Crow's Feet Wrinkle Scale
次要结局
- Subject Self-Assessment score(up to 12 12 weeks)
研究者
研究点 (10)
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