jRCT2071230128已完成不适用
A Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of TO-210 5% in Japanese Subjects With Acne Vulgaris
Torii Pharmaceutical Co.,Ltd0 个研究点目标入组 34 人开始时间: 2024年3月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Other
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 49age old under（—）
- 性别
- All
入选标准
- •Japanese patients aged between 18 and 49 years at informed consent
- •Patients with facial acne valgaris with an Investigator's Global Assessment (IGA) score of 2-4
- •Patients with 5-100 inflammatory lesions (papules, pustules) on the face (including the nose)
排除标准
- •Patients with a history of serious diseases such as brain, liver, kidney, heart, lung, digestive system, blood, endocrine system, metabolic system and mental system, or those currently under treatment
- •Patients whose acne symptoms suddenly changed within at least 12 weeks before screening
- •Patients with other skin diseases (e.g., urticaria, atopic dermatitis) or skin infections (bacterial, fungal, or viral) that might interfere with the evaluation of acne or TO-210 safety, except for tinea pedis
结局指标
主要结局
-
Safety, Pharmacokinetics
次要结局
未报告次要终点
研究者
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