Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Associated With Doxycycline Hyclate 100 mg Tablets Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Vehicle Gel Associated With Doxycycline Hyclate 100 mg Tablets in the Treatment of Severe Acne Vulgaris.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 459
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Total Lesion Counts at Week 12.
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.
详细描述
Further to this study, eligible Subjects with at least good Global Assessment of Improvement at Week 12 will be randomized in a maintenance study (SPR.29075)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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, aged 12 to 35 years inclusive
- •Subjects with severe facial acne (global severity score of 4)
- •Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, excluding the nose
- •Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose
排除标准
- •Subjects with more than 3 nodules or cysts on the face,
- •Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
研究组 & 干预措施
1
Adapalene-BPO + Doxycyline
干预措施: Adapalene BPO Gel associated with Doxycyline Hyclate (Drug)
2
Vehicle + Doxycycline
干预措施: Vehicle Gel associated with Doxycycline Hyclate (Drug)
结局指标
主要结局
Percent Change From Baseline in Total Lesion Counts at Week 12.
时间窗: Week 12
次要结局
- Percent Change From Baseline in Inflammatory Lesion Counts at Week 12.(Week 12)
- Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12(Week 12)
- Success Rate on the Investigator's Global Assessment(Week 12)
- Percent of Subjects With Adverse Events(Up to 12 weeks)