NCT03440671Unknown3 期
A Multicenter, Double-Blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Compare the Efficacy and Safety Study of Hutox Versus Botox® in Subject With Moderate to Severe Glabellar Lines
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- FWS(Facial Wrinkle Severity) Improvement at glabellar line
研究概览
简要总结
A Phase Ⅲ Clinical Trial to Compare the Safety and Efficacy of Hutox versus Botox® in Subject with Moderate to Severe Glabellar 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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Facial Wrinkle Scale (FWS) score > 2 when Subject knits brow extremely
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 including fascioplasty, Prosthesis implantation within 6 Weeks
- •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
研究组 & 干预措施
Hutox Inj
Experimental
Hutox Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM)
干预措施: Hutox Inj (Biological)
Botox Inj
Active Comparator
Botox Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM)
干预措施: Botox Inj (Biological)
结局指标
主要结局
FWS(Facial Wrinkle Severity) Improvement at glabellar line
时间窗: 4 Weeks
Change from Baseline of Glabellar Lines improvement rate(Frown)
次要结局
未报告次要终点
研究者
研究点 (1)
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