Anti P. Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel in the Treatment of Subjects With Acne Vulgaris
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes
研究概览
简要总结
The purpose of this study is to evaluate the antibacterial activity of Epiduo® Gel (Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel) on P. acnes compared to that of Benzoyl Peroxide 2.5% Gel.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with facial acne,
- •Subjects with high levels of P. acnes counts on the forehead
排除标准
- •Female Subjects who are pregnant, nursing or planning a pregnancy during the study,
- •Subjects with acne conglobata, acne fulminans, secondary acne
- •Subjects with known or suspected allergy to one of the test product
研究组 & 干预措施
Epiduo gel
- Dose or Concentration:Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel.
- Mode and Frequency of Administration:Topical to the face, once daily application in the evening.
- Duration of Treatment:12 weeks
干预措施: Epiduo gel (Drug)
BPO gel
- Dose or Concentration:Adapalene 0% / Benzoyl Peroxide 2.5% Gel.
- Mode and Frequency of Administration:Topical to the face, once daily application in the evening.
- Duration of Treatment:12 weeks
干预措施: BPO (Drug)
结局指标
主要结局
Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes
时间窗: Week 12
Quantitative bacterial examinations were performed on the subjects' face during the study. These samplings were performed using a method to quantify the follicular microbiological flora of the skin (at Baseline and Week 12 visits).This method consists of a technique allowing the extraction of the outermost layer of epidermis from hair follicle on the cheek and to culture the samplings in order to have the number of P. acnes. Outcome measure = Change from baseline (Log10 cfu/cm²) in count of Follicular P. acnes at end of the study.
次要结局
- Percent Change (%) in Inflammatory Lesion Counts(Week 12)