NCT04081402Unknown3 期
A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 290
- 试验地点
- 2
- 主要终点
- Change from Baseline of Crow's feet Lines improvement rate [Time Frame: Week 4]
研究概览
简要总结
A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator
排除标准
- •Volunteer who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
- •From screening, Subject who get a plastic Surgery within 48 Weeks
- •Subject who has skin disorder including infection and scar on injection site
- •Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc.
- •Subject who takes a medication including anticoagulant, antithrombotic drug except low dose aspirin (below 325 mg/day)
- •Any condition that, in the view of the investigator, would interfere with study participation
结局指标
主要结局
Change from Baseline of Crow's feet Lines improvement rate [Time Frame: Week 4]
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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