NCT02189629已完成3 期
A LONG-TERM SAFETY AND EFFICACY STUDY OF CD5789 (Trifarotene) 50 µg/g 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
- 453
- 试验地点
- 2
- 主要终点
- Investigator Global Assessment (IGA) Success Rate up to Week 52
研究概览
简要总结
Multi-center, open-label, non-comparative safety and efficacy study with 52 Weeks of treatment on the face and trunk for acne vulgaris.
详细描述
To determine the safety and efficacy of CD5789 (trifarotene) 50 µg/g cream in the long-term treatment (up to 52 Weeks) of subjects with acne vulgaris. Efficacy will be evaluated as a secondary objective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 has a facial acne severity grade of IGA grade 3 (moderate) at Screening and Baseline visits.
- •The Subject has a minimum of 20 inflammatory lesions and 25 non-inflammatory lesions at Screening and Baseline visits on the face.
排除标准
- •The subject has severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.).
- •The Subject has more than 1 nodule on the face at Screening and at Baseline visits.
- •The Subject has any acne cyst on the face at Screening and at Baseline visits.
研究组 & 干预措施
CD5789 (trifarotene) cream
Experimental
干预措施: CD5789 (trifarotene) (Drug)
结局指标
主要结局
Investigator Global Assessment (IGA) Success Rate up to Week 52
时间窗: From Baseline to Week 52
Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear).
次要结局
- Physician Global Assessment (PGA) Success Rate up to Week 52(From Baseline to Week 52)
研究者
研究点 (2)
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