NCT03216408已完成3 期
A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of NEURONOX® vs. BOTOX® in Patients With Moderate to Severe Glabellar Lines
Medy-Tox0 个研究点目标入组 504 人开始时间: 2016年3月30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
- 504
- 主要终点
- 4-grade scale by live assessment of glabellar line severity
研究概览
简要总结
This clinical study evaluates the efficacy and safety of Neuronox compared with Botox in adults with moderate to severe glabellar lines.
详细描述
Subjects are randomly assigned into the two groups at the ratio of 2:1. The purpose of study is to confirm the non-inferiority of Neuronox to Botox in terms of the efficacy and safety in subjects 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
- 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
- 是
入选标准
- •Subjects aged between 18 and 65
- •Subjects with more than grade 2 (moderate) in the investigator's rating of the severity of glabellar lines at maximum frown
排除标准
- •Subjects with medical conditions who may be greater risk due to the administration of the investigational drugs
- •Subjects with skin disorders at the injection site
研究组 & 干预措施
Neuronox
Experimental
Botulinum toxin type A for Injection
干预措施: Neuronox (Drug)
Botox
Active Comparator
Botulinum toxin type A for Injection
干预措施: Botox (Drug)
结局指标
主要结局
4-grade scale by live assessment of glabellar line severity
时间窗: 4 weeks after injection
Glabellar line improvement rate at maximum frown
次要结局
未报告次要终点
研究者
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