NCT00211497已完成2 期
A Phase II, Randomized, Vehicle-Controlled, Double-Blind, Multi-Center Study to Evaluate Safety and Efficacy of MBI 226 1.25% and 2.5% Acne Solutions Applied Topically for 12 Weeks to Subjects With Acne Vulgaris
BioWest Therapeutics Inc0 个研究点目标入组 255 人开始时间: 2003年1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
- 255
- 主要终点
- - percent change from Baseline to Week 12 in inflammatory acne lesion counts
研究概览
简要总结
This is a Phase II, randomized, vehicle-controlled, double-blind, multi center study to evaluate the efficacy and safety of topically applied MBI 226 1.25% and 2.5% Acne Solutions as anti-acne preparations in human subjects with facial acne vulgaris.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females 12 years and older
- •Presence of inflammatory and non-inflammatory lesions
排除标准
- •Acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne, etc.)
- •Active facial cysts or any nodulocystic lesions
结局指标
主要结局
- percent change from Baseline to Week 12 in inflammatory acne lesion counts
次要结局
- Single continuous endpoints:
- • Percent change from Baseline to Week 6 and Week 12 in non inflammatory acne lesion counts
- • The percent change from Baseline to Week 6 and Week 12 in total acne lesion counts
- Multiple continuous endpoints:
- • Percent change from Baseline to Weeks 3, 6, 9 and 12 in inflammatory acne lesion counts
- • Percent change from Baseline to Weeks 3, 6, 9 and 12 in non-inflammatory acne lesion counts
- • Percent change from Baseline to Weeks 3, 6, 9 and 12 in total acne lesion counts
- Categorical endpoints:
- • Dichotomized Physicians Global Severity Assessment scores at Week 6 and Week 12
- • PGSA absolute scores at Week 6 and Week 12
- • PGSA absolute scores over Baseline, Week 6 and Week 12
研究者
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