Clinical Trial To Evaluate ANT-1207 In Subjects With Lateral Canthal Lines
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 6
- 主要终点
- Efficacy will be assessed by Investigator's Global Assessment Score
研究概览
简要总结
The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 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
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •mild to moderate Crow's Feet wrinkles (IGA 2-3) at rest
- •moderate to severe Crow's Feet (IGA 3-4) 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
Dose 1
Dose 1
干预措施: ANT-1207 (Biological)
Placebo Comparator
干预措施: Botulinum Toxin Type A (Biological)
Placebo Comparator
干预措施: ANT-1207 (Biological)
Dose 4
Dose 4
干预措施: Botulinum Toxin Type A (Biological)
Dose 3
Dose 3
干预措施: Botulinum Toxin Type A (Biological)
Dose 5
Dose 5
干预措施: Botulinum Toxin Type A (Biological)
Dose 2
Dose 2
干预措施: Botulinum Toxin, Type A (Biological)
Dose 5
Dose 5
干预措施: Botulinum Toxin, Type A (Biological)
Dose 4
Dose 4
干预措施: Botulinum Toxin, Type A (Biological)
Dose 3
Dose 3
干预措施: Botulinum Toxin, Type A (Biological)
Dose 3
Dose 3
干预措施: ANT-1207 (Biological)
Dose 2
Dose 2
干预措施: Botulinum Toxin Type A (Biological)
Dose 2
Dose 2
干预措施: ANT-1207 (Biological)
Dose 1
Dose 1
干预措施: Botulinum Toxin Type A (Biological)
Dose 1
Dose 1
干预措施: Botulinum Toxin, Type A (Biological)
结局指标
主要结局
Efficacy will be assessed by Investigator's Global Assessment Score
时间窗: 2 weeks
Wrinkle scale with definitions of severity
次要结局
- Subject Self Assessment (SSA) scale(2 Weeks)
- Investigator Global Assessment scale(Week 1, 2, 4, 8, 12)