EUCTR2015-002540-13-ES进行中（未招募）1 期
A Multi-Center, Randomized, Double-Blind, Parallel-Group Vehicle Controlled Study To Compare The Efficacy And Safety Of CD5789 50µg/g Cream Versus Vehicle Cream In Subjects With Acne Vulgaris - Double-Blind Efficacy and Safety of CD5789 50µg/g Cream versus Vehicle Cream in Acne Vulgaris
Galderma R&D SNC0 个研究点目标入组 1,200 人开始时间: 2015年10月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female, 9 years of age and older, at the Screening visit.
- •2. The Subject has a facial acne severity grade of 3 (moderate) on the Investigator Global Assessment (IGA) scale at Screening and Baseline.
- •3. The subject has a minimum of 20 inflammatory lesions and 25 noninflammatory lesions on the face at Screening and Baseline.
- •4. The subject has truncal acne severity grade of 3 (moderate) on the Physician Global assessment (PGA) scale at Screening and Baseline visits on trunk (shoulders, upper back and upper anterior chest) reachable for self-application of study drug by the subject (optional criterion for subject between 9 and 11 years of age).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 720
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 478
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1. The subject has severe forms of acne (e.g., acne conglobata, acne fulminans) or secondary acne form (e.g.,chloracne, drug-induced acne, etc.).
- •2. The subject has more than 1 nodule on the face at Screening and Baseline.
- •3. The subject has more than 1 nodule on the trunk at Screening and Baseline
- •4. The subject has any acne cysts on the trunk at Screening and at Baseline.
研究者
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