JPRN-jRCT2080224660已完成3 期
A Multicenter, Open-label, Uncontrolled, Long-term Trial to Demonstrate the Safety and Efficacy of 1% OPA-15406 Ointment in Adult Patients with Atopic Dermatitis and of 0.3% and 1% OPA-15406 Ointments in Pediatric Patients with Atopic Dermatitis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 366
研究概览
简要总结
Administration of 1% OPA-15406 ointment to adult patients with AD and 0.3% or 1% OPA-15406 ointment to pediatric patients with AD for 52 weeks raised no marked safety issues and was well tolerated by most of these patients. In addition, the efficacy of OPA-15406 ointment was demonstrated, such as its improving effect on the severity of rash based on IGA and EASI scores after administration for 52 weeks.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 2age old 至 ot applicable(—)
- 性别
- All
入选标准
- •1.Diagnosis of AD based on the Japanese Dermatological Association's criteria
- •2.Atopic dermatitis affecting more than or equal to 5% of body surface area(BSA, excluding scalp) at the screening and baseline examinations
- •3.IGA score of more than or equal to 2 at the screening and baseline examinations
排除标准
- •Subjects who have an AD or contact dermatitis flare-up defined as a rapid intensification of AD,within 28 days prior to the baseline examination
研究者
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