NCT00211523已完成2 期
Phase II, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of MBI 226 2.5% and 5.0% Acne Solutions Applied Topically for 6 Weeks to Subjects With Acne Vulgaris
BioWest Therapeutics Inc0 个研究点目标入组 75 人开始时间: 2000年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 主要终点
- - percent change in inflammatory, non-inflammatory, and total acne lesion counts over entire study and dichotomized Global Severity Assessment
研究概览
简要总结
This study investigates the safety and efficacy of MBI 226 2.5% and 5.0% Acne Solutions, applied topically for six weeks, in the treatment of acne.
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
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, ages 13 and up, exhibiting high levels of facial P. acnes
- •Presence of inflammatory and non-inflammatory lesions
排除标准
- •Acne conglobata, acne fulminans, or secondary acne (chlorine, drug-induced acne, etc.)
- •Active facial cysts
结局指标
主要结局
- percent change in inflammatory, non-inflammatory, and total acne lesion counts over entire study and dichotomized Global Severity Assessment
次要结局
- - percent change in lesion counts after ~2 and ~4 weeks
- - Global Severity Assessment
研究者
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