Phase II, Randomized, Double-blind, Placebo Controlled, Multi-Center, Dose-ranging and Open Label Extension Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Moderate to Severe Lateral Canthal Lines
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Facial wrinkle scale(FWS) change of lateral canthal line at maximum smile
研究概览
简要总结
This phase 2 study includes two treatment period; 1)Dose- ranging period, Day 0 to 16 weeks, which will assess dose-related safety/tolerance, and the potential to improve the appearance of lateral canthal lines and 2) open-label extension period, 16 weeks to 52 weeks, which will evaluate the long term-safety of MBA-P01
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
- 否
入选标准
- •Male or female aged 18 to 65
- •Bilaterally symmetrical moderate to severe lateral canthal lines(LCLs) at maximum smile as assessed by both investigator and subject using FWS
排除标准
- •History of facial nerve paralysis
- •Any eyebrow or eyelied ptosis as determined by the investigator
研究组 & 干预措施
MBA-P01 24U
Experimental group; Dose: 24U
干预措施: MBA-P01(Botulinum toxin A) (Drug)
MBA-P01 12U
Experimental group; Dose: 12U
干预措施: MBA-P01(Botulinum toxin A) (Drug)
Placebo
Placebo group; normal saline
干预措施: Placebo (Drug)
结局指标
主要结局
Facial wrinkle scale(FWS) change of lateral canthal line at maximum smile
时间窗: 4 weeks
Proportion of subjects achieving at least a 2 grade decrease from baseline and a grade 0 or 1 in Facial Wrinkle Scale (0: none to 3: severe) of LCL at maximum smile, as assessed by the investigator and subject
次要结局
未报告次要终点