Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Vehicle Gel as a 6-month Acne Maintenance Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- Maintenance Success for Total Lesions at Week 24
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.
详细描述
This study is a follow-up to RD.03.SPR.29074 - ACCESS I / NCT00688064 - "Adapalene-BPO Gel Associated With Doxycycline 100 mg in the Treatment of Severe 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
- 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
- •Subjects who completed the previous study (RD.03.SPR29074 - NCT00688064)and had obtained at least a good Improvement (Grade, 0, 1, 2 or 3)
排除标准
- •Female Subjects who are pregnant, nursing or planning a pregnancy during the study
- •Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc).
研究组 & 干预措施
1
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel once daily
干预措施: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel (Drug)
2
Vehicle Gel once daily
干预措施: Vehicle Gel (Drug)
结局指标
主要结局
Maintenance Success for Total Lesions at Week 24
时间窗: Week 24
Maintenance success for total lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of total lesion counts.
次要结局
- Maintenance Success for Non-inflammatory Lesions at Week 24(Week 24)
- Investigator Global Assessment (IGA) Maintenance Success at Week 24(Baseline, Week 24)
- Percent of Subjects With Adverse Events(Up to 24 weeks)
- Maintenance Success for Inflamatory Lesions at Week 24(Week 24)