NCT01044264已完成不适用
A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled Study Comparing Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations in the Treatment of Moderate to Severe Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Padagis LLC
- 入组人数
- 602
- 主要终点
- Reduction of Inflammatory Lesions
研究概览
简要总结
A randomized, double-blind, multiple-site, placebo-controlled, parallel-group clinical study conducted to evaluate the bioequivalence of two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel formulations.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy men or women, 12 years of age and older
- •willing to participate and sign a copy of the informed consent form
- •moderate to severe facial acne
排除标准
- •history of allergy or hypersensitivity to clindamycin or benzoyl peroxide
- •pregnant or lactating women
- •evidence of a clinically significant disorder
- •receipt of any drugs as part of a research study within 30 days prior to study dosing
- •use of systemic, topical or facial products which may interfere with study
- •significant facial hair, tattoos, excessive facial scarring, active facial sunburn, or peeling due to sunburn
研究组 & 干预措施
1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Active Comparator
Test product
干预措施: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel (Drug)
DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Active Comparator
Reference product
干预措施: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction of Inflammatory Lesions
时间窗: Baseline and week 11
The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules).
次要结局
未报告次要终点
研究者
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