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
- 75
- 试验地点
- 5
- 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, 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
- 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
研究组 & 干预措施
Vehicle
Vehicle
干预措施: Vehicle (Biological)
ET-01 1100U
botulinum toxin, Type A, Dose 2, 1100 U
干预措施: botulinum toxin, Type A (Biological)
ET-01 345U
botulinum toxin, Type A, Dose 1, 345 U
干预措施: botulinum toxin, Type A (Biological)
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 Time Between Week 4 and Week 12(Week 4, 8,and 12)