JPRN-jRCT2080223499已完成3 期
Phase III Clinical Study of JTE-052 - Randomized Controlled and Long-term Extension Study in Patients with Atopic Dermatitis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 158
研究概览
简要总结
ollowing dermal application of JTE-052 ointment 0.5% twice daily for 4 weeks in patients with atopic dermatitis, the percent improvement in mEASI score at the EOT was significantly greater in the JTE-052 ointment 0.5% group than in the placebo group, demonstrating the superiority of the JTE-052 ointment 0.5% group over the placebo group. This study confirmed that dermal application of JTE-052 ointment 0.5% twice daily for 28 weeks was safe and well tolerated in Japanese patients with atopic dermatitis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 16age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patients 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 baseline
- •Use of topical corticosteroids (strong, medium or weak) within 7 days before baseline
研究者
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