JPRN-jRCT2080224628已完成3 期
A Multicenter, Randomized, Double-blind, Vehicle controlled, Parallel-group Comparison Trial to Demonstrate the Superiority of 0.3% and 1%OPA-15406 Ointment to the Vehicle 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
- 251
研究概览
简要总结
OPA-15406 (0.3% and 1%) ointment is an effective treatment for pediatric AD in the studied population. Treatment with OPA-15406 (0.3% and 1%) ointment twice daily for up to 4 weeks was safe and well tolerated in both groups of pediatric subjects with AD.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 2age old 至 <= 14age old（—）
- 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%, to less than or equal to 40% of body surface area (BSA, excluding scalp) at the screening and baseline examinations
- •3 IGA score of 2 or 3 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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