NCT01138514已完成3 期
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo Israel Pharmaceuticals, Ltd., Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to a Comparator Clindamycin / Benzoyl Peroxide Topical Gel, and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Padagis LLC
- 入组人数
- 1,555
- 主要终点
- Percent Change From Baseline in Non-inflammatory Lesions
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy men or women, 12 to 65 years of age
- •Willing to participate and sign provide written consent
- •Moderate to severe acne
排除标准
- •Pregnant or lactating women
- •History of unresponsiveness or hypersensitivity to clindamycin, benzoyl peroxide or lincomycin
- •Use of systemic, topical or facial products which may interfere with the study
- •Participation in any clinical study in the 30 days prior to study entry
- •Prolonged exposure to sunlight or excessive exposure to UV lights
- •Chronic use of NSAIDS
研究组 & 干预措施
Clindamycin 1%/Benzoyl Peroxide 5%
Active Comparator
干预措施: Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo) (Drug)
Reference Product
Active Comparator
干预措施: Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin) (Drug)
Vehicle
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Non-inflammatory Lesions
时间窗: 10 weeks
Percent Change From Baseline in Inflammatory Lesions
时间窗: 10 weeks
次要结局
- Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)(10 weeks)
研究者
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