NCT00441415已完成3 期
Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Compared to Clindamycin 0.1% / Benzoyl Peroxide 5% Gel in the Treatment of Acne Vulgaris
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 272
- 试验地点
- 4
- 主要终点
- Percent change from Baseline in total lesion count (sum of non inflammatory and inflammatory lesions) at week 12.
研究概览
简要总结
The purpose of this study is to demonstrate the non-inferior efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel when compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel in Subjects with acne vulgaris after a 12-week treatment period.
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
- Single
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female Subjects of any race, between the age of 12 and 35 years inclusive, with acne vulgaris, meeting specific inclusion/
排除标准
- •Main inclusion criteria:
- •Male or female Subjects of any race, aged 12 to 35 years inclusive, with facial acne vulgaris,
- •Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face,
- •Subjects with a minimum of 30 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose.
- •Main exclusion criteria:
- •Subjects with acne cystic lesions,
- •Subjects with acne conglobate, acne fulminancy, secondary acne (chloracne, drug-induced acne, etc.).
结局指标
主要结局
Percent change from Baseline in total lesion count (sum of non inflammatory and inflammatory lesions) at week 12.
次要结局
- Global severity assessment at each post Baseline visit
- Percent change from Baseline in total inflammatory and non inflammatory lesion counts at each intermediate visit
研究者
研究点 (4)
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