NCT02073461已完成2 期
A Multicenter, Randomized, Double-blinded, Vehicle-controlled Parallel Group Efficacy and Safety Study of 2 Different Concentrations of CD1579 Gels Versus Vehicle in the Treatment of Acne Vulgaris.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Percent Changes From Baseline in Total Lesion Counts
研究概览
简要总结
This study is to assess the efficacy and safety of two concentrations of CD1579 (2.5% and 5%) versus vehicle in the treatment of acne vulgaris in the Japanese patients.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women at the age of 12 or older at the Screening visit.
- •Those with clinical diagnosis of acne vulgaris with more than 20 noninflammatory lesions (open and closed comedones) and 12 to 100 (inclusive) inflammatory lesions (papules, pustules and nodules) on the face (forehead, both cheeks, nose and chin).
排除标准
- •Those with more than two nodular acne lesions or any cysts.
- •Those with the diagnosis of any acne conglobata, any acne fulminans, any chloracne, or any drug induced acne.
- •Those who have clinically significant abnormal findings or conditions on skin other than acne such as atopic dermatitis, perioral dermatitis, or rosacea that potentially interfere with study assessments according to Investigator's judgment
研究组 & 干预措施
CD1579 2.5%
Experimental
Benzoyl Peroxide 2.5%
干预措施: CD1579 2.5% (Drug)
CD1579 5%
Experimental
Benzoyl Peroxide 5%
干预措施: CD1579 5% (Drug)
Vehicle
Placebo Comparator
Vehicle
干预措施: Vehicle (Drug)
结局指标
主要结局
Percent Changes From Baseline in Total Lesion Counts
时间窗: Baseline - Week 12
Median percent reductions from Baseline in total lesion count (ITT-LOCF)
次要结局
- Local Tolerability (Erythema)(12 weeks)
- Local Tolerability (Dryness)(12 weeks)
- Local Tolerability (Scaling)(12 weeks)
- Local Tolerability (Pruritus)(12 weeks)
- Percent of Subjects With Adverse Events(up to 12 weeks)
- Local Tolerability (Stinging/Burning)(12 weeks)
研究者
研究点 (1)
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