NCT01138735已完成4 期
A Multi-center, Randomized, Vehicle-controlled, Double-blind, Study to Evaluate the Safety and Efficacy of Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Administered Once Daily for the Treatment of Subjects 9 to 11 Years of Age With Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 285
- 试验地点
- 25
- 主要终点
- Change From Baseline in Total Lesion Counts
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.
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
- 9 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acne vulgaris with facial involvement
- •Score of 3 (moderate) on the Investigator's Global Assessment (IGA) scale
- •A minimum of 20 but not more than 100 total lesions (Noninflammatory and/or Inflammatory) on the face (including the nose) at Baseline
排除标准
- •Acne nodule or acne cyst
- •Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment
- •Underlying diseases and/or dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments
- •Use of prohibited medications prior to the study and/or are unwilling to refrain from such use during the study
研究组 & 干预措施
adapalene/benzoyl peroxide
Active Comparator
Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
干预措施: adapalene/benzoyl peroxide (Drug)
Topical Gel Vehicle
Placebo Comparator
Topical Gel Vehicle applied topically once daily for 12 weeks
干预措施: Topical Gel Vehicle (Drug)
结局指标
主要结局
Change From Baseline in Total Lesion Counts
时间窗: Baseline to Week 12 (LOCF)
Success Rate
时间窗: Baseline to Week 12 (Last Observation Carried Forward [LOCF])
Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA)
次要结局
- Percent Change in Total Lesion Counts From Baseline(Baseline to Week 12 (LOCF))
- Change in Inflammatory Lesion Counts From Baseline(Baseline to Week 12 (LOCF))
研究者
研究点 (25)
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