NCT03408236已完成3 期
Randomized, Double-blind, Active-controlled, Multicenter, Phase I/III Clinical Trial to Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines
Hugel1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2018年1月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Facial Wrinkle Scale(FWS) severity of crow's feet lines(CFL) at maxium smile as assessed by investigators
研究概览
简要总结
To determine the efficacy and safety of Botulax® in treatment of crow's feet line
详细描述
- Allocation: Randomized
- Masking: Double Blind
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female of at least 19 to 65 years old
- •Bilaterally symmetrical moderator-to-severe CFL at maximum smile on the FWS as rated by the investigator
排除标准
- •Subject with hypersensitivity to the investigational products or their components
- •Female subject who are pregnant or lactating
- •Subject who are unable to communicate or follow the instructions
- •Subject who are not eligible for this study based on the judgment of an investigator
研究组 & 干预措施
Botulax
Experimental
Single dose
干预措施: Botulinum toxin type A (Drug)
Botox
Active Comparator
Single dose
干预措施: Botulinum toxin type A (Drug)
结局指标
主要结局
Facial Wrinkle Scale(FWS) severity of crow's feet lines(CFL) at maxium smile as assessed by investigators
时间窗: 4weeks
The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported as assessed by investigators
次要结局
未报告次要终点
研究者
研究点 (1)
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