NCT01880320已完成3 期
A Multi-center, Randomized, Double-blind, Parallel-group Vehicle and Active Controlled Study to Compare the Efficacy and Safety of CD0271 0.3% / CD1579 2.5% Topical Gel Versus Topical Gel Vehicle in Subjects With 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
- Galderma R&D
- 入组人数
- 503
- 试验地点
- 5
- 主要终点
- Success Rate
研究概览
简要总结
The study hypothesis are based on the assumption that :
- CD0271 0.3%/CD1579 2.5% Gel provides superior clinical efficacy compared with Topical Gel Vehicle in the overall population and in the subgroup of severe Subjects
- CD0271 0.3%/CD1579 2.5% Gel applied once daily for up to 12 weeks has an acceptable safety and tolerability profile
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
- •Male or female, who is 12 years of age or older at Screening visit.
- •Clinical diagnosis of acne vulgaris with facial involvement.
- •An IGA of Moderate (3) or Severe (4) at Baseline visit.
- •A minimum of 20 but not more than 100 inflammatory lesions (papules and pustules) on the face (including the nose) at Baseline visit.
- •A minimum of 30 but not more than 150 non-inflammatory lesions (open comedones and closed comedones) on the face (including the nose) at Baseline visit.
排除标准
- •More than 2 acne nodules on the face at Baseline visit.
- •Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
- •Underlying diseases or other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis or rosacea. This includes clinically significant abnormal findings, uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial.
- •The subject has received, applied or taken some specified treatments within the specified timeframe prior to the Baseline visit
- •The subject is unwilling to refrain from use of prohibited medication during the clinical trial.
- •Use of hormonal contraceptives solely for control of acne.
研究组 & 干预措施
CD0271 0.3% /CD1579 2.5% Gel
Experimental
active arm
干预措施: CD0271 0.3% / CD1579 2.5% (Drug)
CD0271 0.1% / CD1579 2.5%
Active Comparator
Comparator arm
干预措施: CD0271 0.1% / CD1579 2.5% (Drug)
Topical Gel Vehicle
Placebo Comparator
Placebo arm
干预措施: Topical Gel Vehicle (Drug)
结局指标
主要结局
Success Rate
时间窗: Week 12
Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA). Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets.
Changes From Baseline in Inflammatory Lesion Counts
时间窗: Baseline - Week12
Changes From Baseline in Non-Inflammatory Lesion Counts
时间窗: Baseline - Week 12
次要结局
未报告次要终点
研究者
研究点 (5)
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