Clinical Trial to Evaluate ET-01 in Subjects With Lateral Canthal Lines
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Number of Participants With a Response Defined as IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2
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, also known as Crow's Feet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •25 - 65 years of age
- •minimal 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 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 IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2
时间窗: Week 4
Composite of Investigators Global Assessment \& Subject Self-Assessment on contraction. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). The same scale is used for the Investigator's Assessment as well as the Subject's Self Assessment. To count, both assessments (on contraction) have to be "responders" defined as Score ≤ 2.
次要结局
- Total Number of Observations With a Response Defined as IGA-C Score ≤ 2(Week 2, 4, 8,12,18)
- Total Number of Observations With a Response Defined as SSA-C Score ≤ 2(Week 2, 4, 8,12,18)