jRCT2031230713已完成不适用
Phase III Clinical Study of JTE-052 new drug product - Bioequivalence study between new drug product and JTE-052 ointment in patients with atopic dermatitis -
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 234
- 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
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 16age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients diagnosed with moderate or severe atopic dermatitis
- •Modified Eczema Area and Severity Index (mEASI) = >10
排除标准
- •Patients with active infection at the study drug application site
- •Use of topical corticosteroids (strongest or very strong) within 28 days before an initiation of study drug (Week 0)
- •Use of topical corticosteroids (strong, medium or weak) within 7 days before an initiation of study drug (Week 0)
结局指标
主要结局
-
Percent change in mEASI score from Week 0 at the final evaluation (the end of treatment [EOT])
次要结局
未报告次要终点
研究者
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