Efficacy and Safety Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of 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
- 123
- 试验地点
- 1
- 主要终点
- Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline.
研究概览
简要总结
The purpose of this study is to compare the tolerability of 3 treatment regimens containing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The efficacy of the four treatment regimens will also be evaluated.
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 (Investigator)
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 mild or moderate facial acne vulgaris
- •Subjects with skin phototype I to IV
排除标准
- •Subjects with more than 1 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 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
干预措施: Adapalene-BPO 3-hour daily application before bedtime (Drug)
2
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
干预措施: Adapalene-BPO Gel every other day application (Drug)
3
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
干预措施: Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion (Drug)
4
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
干预措施: Adapalene BPO Gel standard daily overnight application (Drug)
结局指标
主要结局
Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline.
时间窗: Week 4
Total Sum Score (TSS) is the sum of the 4 local tolerability scores for dryness, erythema, scaling and stinging/burning evaluated at each visit \[None=0, Mild=1, Moderate=2 and Severe=3\]. In consequence, it ranges from 0 \[better outcome\] to 12 \[worse outcome\]and was calculated for each study visit.
次要结局
未报告次要终点