NCT02556788已完成3 期
A Multi-Center, Randomized, Double-Blind, Parallel-Group Vehicle Controlled Study To Compare The Efficacy And Safety Of CD5789 (Trifarotene) 50µg/g Cream Versus Vehicle Cream 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
- 1,212
- 试验地点
- 4
- 主要终点
- Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)
研究概览
简要总结
Assessment of the efficacy and safety of CD5789 (Trifarotene) 50µg/g cream applied once daily for 12 weeks in subjects 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is a male or female, 9 years of age or older, at Screening visit.
- •The Subject has moderate acne at Screening and Baseline.
- •The subject is a female of non childbearing potential
- •The subject is a female of childbearing potential with a negative pregnancy test and who is strictly abstinent or who agrees to use an effective and approved contraceptive method for the duration of the study and at least 1 month after the last study drug application.
排除标准
- •The subject has severe forms of acne (e.g., acne conglobate, acne fulminant) or secondary acne form (e.g.,chloracne, drug-induced acne, etc.).
- •The subject has any uncontrolled or serious disease or any medical or surgical condition that may either interfere with the interpretation of the trial results and/or put the subject at significant risk (according to the Investigator's judgment) if the subject takes part to the trial.
- •The subject has been exposed to excessive ultraviolet (UV) radiation within one month prior to the Baseline visit or the subject is planning intense UV exposure during the study (i.e., occupational exposure to the sun, sunbathing, tanning salon use, phototherapy, etc.)
- •The subject is unwilling to refrain from use of prohibited medication during the clinical trial
研究组 & 干预措施
Placebo Cream
Placebo Comparator
Placebo Cream
干预措施: Placebo Cream (Drug)
CD5789 (Trifarotene) 50µg/g Cream
Experimental
CD5789 (trifarotene) 50µg/g Cream
干预措施: CD5789 (trifarotene) 50µg/g Cream (Drug)
结局指标
主要结局
Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)
时间窗: From Baseline to Week 12
Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.
次要结局
未报告次要终点
研究者
研究点 (4)
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