NCT02580370已完成3 期
Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Lateral Canthal Lines
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Composite endpoint based upon the investigator global assessment (IGA-LCL) and patient assessment of severity (PSA) of lateral canthal lines
研究概览
简要总结
This is a safety and efficacy study of botulinum toxin type A in subjects with 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In good general health
- •Moderate to severe lateral canthal lines when evaluated at rest based on the investigator's global assessment
- •Moderate to severe lateral canthal lines when evaluated at rest based on the patient assessment of severity
排除标准
- •Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis
- •Muscle weakness or paralysis, particularly in the area receiving study treatment
- •Active skin disease or irritation or disrupted barrier at the treatment area
- •Active eye disease or irritation
- •Eyelid ptosis, excessive dermatochalasis, deep dermal scarring, or inability to substantially effect the LCL to be treated by manually spreading the skin apart
- •Use of topical prescription retinoid product(s) in the lateral canthal areas during the 3 months prior to Screening
- •Undergone any procedures that may affect the lateral canthal region during the 12 months prior to Screening
- •Treatment with botulinum toxin type A in the lateral canthal areas in the 6 months prior to Screening or 3 months anywhere else in the body
结局指标
主要结局
Composite endpoint based upon the investigator global assessment (IGA-LCL) and patient assessment of severity (PSA) of lateral canthal lines
时间窗: Week 4
次要结局
- Investigator Global Assessment with 2 points or greater improvement from baseline(Week 4)
- Patient Severity Assessment with 2 points or greater improvement from baseline(Week 4)
- Patient Severity Assessment with 1 points or greater improvement from baseline(Week 4)
- Investigator Global Assessment with 1 point or greater improvement from baseline(Week 4)
研究者
研究点 (1)
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