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临床试验/JPRN-jRCT2080224660
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

Otsuka Pharmaceutical Co., LTD.0 个研究点目标入组 366 人开始时间: 2019年4月25日最近更新:
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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