NCT03912805已完成2 期
Clinical Trial to Evaluate ET-01 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
- 38
- 试验地点
- 6
- 主要终点
- Number of Participants With a Response Defined as Change in IGA-C (Investigators Global Assessment) Score by at Least 2 Ordinals From Baseline to Week 4
研究概览
简要总结
This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).
详细描述
This product is being tested for its ability to reduce lateral canthal lines (LCL), also known as 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •females 25 - 65 years of age
- •minimal to moderate Crow's Feet wrinkles at rest
- •moderate to severe Crow's Feet on contraction
- •adequate vision to assess facial wrinkles in a mirror
- •willingness to refrain from products affecting skin remodeling
- •female subjects must be not pregnant and non-lactating
- •subjects should be in good general health
排除标准
- •history of adverse reactions to any prior botulinum toxin treatments
- •history of vaccination or non-response to any prior botulinum toxin treatments
- •botulinum toxin treatment in the prior 6 months
- •present or history of neuromuscular disease, eyelid ptosis, muscle weakness, paralysis, or "dry eye"
- •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
结局指标
主要结局
Number of Participants With a Response Defined as Change in IGA-C (Investigators Global Assessment) Score by at Least 2 Ordinals From Baseline to Week 4
时间窗: Week 4
Investigators Global Assessment of the Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). Response is defined as change by at least two ordinals from Baseline to Week 4.
次要结局
- Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score at Any Post Baseline Visit(Week 1, 2, 4, 8,12,18, and 26)
- Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Post Baseline Visit(Week 1, 2, 4, 8,12,18, and 26)
研究者
研究点 (6)
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