NCT01809964已完成2 期
Clinical Trial to Evaluate ANT-1401 in Subjects With Lateral Canthal Lines
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 7
- 主要终点
- Investigator's Global Assessment Scale
研究概览
简要总结
The purpose of this study is to confirm the effect of ANT-1401 in the treatment of Lateral Canthal 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
- 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 (IGA 1-2) at rest
- •moderate to severe Crow's Feet (IGA 2-3) on contraction
- •moderate to severe Crow's Feet (SSA 2-3) on contraction
- •Have adequate vision to assess facial wrinkles in a mirror
排除标准
- •botulinum toxin treatment in the prior 6 months
- •history of periocular surgery, brow lift or related procedures
- •soft tissue augmentation in the lateral canthal region in the prior 12 months
- •dermabrasion or laser treatment in the periocular region in the last 6 months
- •topical prescription-strength retinoids in the prior 3 months
- •present or history of neuromuscular disease
- •present or history of "dry eye"
- •systemic aminoglycoside use in the week prior to treatment application
结局指标
主要结局
Investigator's Global Assessment Scale
时间窗: Week 4
次要结局
- Subject Self-Assessment(Week 4)
研究者
研究点 (7)
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