Evaluation of the Effectiveness of Epiduo® Gel (Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel) in Reducing Antibiotic Sensitive and Resistant Strains of P Acnes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change From Baseline in Quantitative Bacteriology Measurements at Week 4
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of Epiduo® Gel in reducing antibiotic sensitive and resistant strains of P acnes in vivo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Healthy adult male or female subjects 18 years of age and older, with no past or present history of any significant internal disease
- •Subjects who:
- •show a high degree of fluorescence of the facial skin under a Wood's lamp, indicating the presence of P acnes
- •have Baseline P acnes count of > 10,000 per cm2 CFU of the facial skin (forehead)
- •have high level resistance to erythromycin, variable resistance to clindamycin, resistance to tetracycline and variable resistance to doxycycline and minocycline
排除标准
- •Subjects who exhibit any skin disorders of an acute or chronic nature (e.g., psoriasis, eczema, etc)
- •Subjects who have taken topical or systemic antibiotics within 4 weeks prior to baseline assessments
- •Subjects who have used other medications which may influence skin surface P acnes levels
- •Subjects who are unwilling to refrain from using toners, astringents or other drying agents on the face during the study
研究组 & 干预措施
Study Treatment
Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)
Other Names:
Epiduo® Gel Apply once daily
干预措施: Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel) (Drug)
结局指标
主要结局
Change From Baseline in Quantitative Bacteriology Measurements at Week 4
时间窗: Week 4
Mean log10 values of P. acnes from swabbed skin samples Please note: Quantitative bacteriologic cultures were obtained from the facial skin (forehead) at screening, baseline, week 2 and week 4/early termination. Samples were obtained according to a modification of the technique of Williamson and Kligman. CFUs of P. acnes were counted at the dilution that contained between 10 and 100 CFUs. Total densities of P. acnes were calculated and reported as the average (of both plates) of the log10 CFUs per cm².
次要结局
- Worst Post Baseline Tolerability Assessment - Erythema(Week 4)
- Worst Post Baseline Tolerability Assessment - Dryness(Week 4)
- Worst Post Baseline Tolerability Assessment - Scaling(Week 4)
- Worst Post Baseline Tolerability Assessment - Stinging/Burning(Week 4)