Phase Ⅲ, Randomized, Double-Blind, Active Controlled, Multi-Center, Clinical Trial to Evaluate the Efficacy and Safety of CUNOX® in Patients With Moderate to Severe Glabellar Lines
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment of glabellar line severity
研究概览
简要总结
To Confirm the non-inferiority of CUNOX® to BOTOX® in the glabellar line improvement of 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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged between 18 and 65
- •Subjects attaining ≥ grade 2 (moderate) in the investigator's rating of the severity of glabellar lines at maximum forced frown
- •Subjects who voluntarily sign the informed consent
排除标准
- •Subjects with allergy or hypersensitivity to the investigational drugs or their components
- •Subjects who are participating in other clinical trials or have participated in clinical trials 30 days before screening
- •Subjects who are not eligible for this study at the discretion of the investigator
研究组 & 干预措施
Cunox
Cunox (botulinum toxin type A), 0.1 mL injected into each of 5 sites once.
干预措施: Cunox (Drug)
Botox
Botox (botulinum toxin type A), 0.1 mL injected into each of 5 sites once.
干预措施: Botox (Drug)
结局指标
主要结局
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment of glabellar line severity
时间窗: at 4 weeks after the injection.
An investigator makes a live assessment of subject's glabellar lines at maximum frown on a 4-grade scale (0 (none), 1 (mild), 2 (moderate) and 3 (severe)) 4 weeks after the administration of the investigational drug or the comparator. 0 or 1 point is considered as "improved" and glabellar line improvement rate is calculated.
次要结局
未报告次要终点