NCT04143815已完成2 期
PhaseII, 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 Glabellar Lines
Medy-Tox1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年5月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Facial Wrinkle Scale(FWS) change
研究概览
简要总结
This study will determine the effect of MBA-P01 in subjects with glabellar lines at a range of doses compared with placebo.
This study includes two treatment period; 1) Dose-ranging period, Day0 to 16weeks and 2) Open-label extension period, 16 weeks to 52.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female over 18 years of age
- •Bilaterally symmetrical moderate to severe GL at maximum frown 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 20U
Experimental
Experimental group, Dose: 20U
干预措施: MBA-P01 (Botulinum toxin A) (Drug)
MBA-P01 30U
Experimental
Experimental group, Dose: 30U
干预措施: MBA-P01 (Botulinum toxin A) (Drug)
MBA-P01 10U
Experimental
Experimental group, Dose: 10U
干预措施: MBA-P01 (Botulinum toxin A) (Drug)
Placebo
Placebo Comparator
Placebo group, Normal saline
干预措施: Placebo (Drug)
结局指标
主要结局
Facial Wrinkle Scale(FWS) change
时间窗: 4 weeks
Proportion of subjects achieving at least a 2-grade decrease from baseline in score of Facial Wrinkle Scale (FWS) (0:none to 3: severe) of Glabellar line at maximum frown
次要结局
未报告次要终点
研究者
研究点 (1)
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