JPRN-UMIN000051817尚未招募Unknown
An observational study to investigate the efficacy and safety of maintenance therapy with difamilast for patients with atopic dermatitis - 271-JMA-22003
Asai Dermatology Clinic0 个研究点目标入组 160 人开始时间: 2023年10月1日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 16years-old 至 70years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1.Patients with active or recurrent skin diseases other than atopic dermatitis that require treatment, 2.Patients with a history of treatment with difamilast at the research site (only in the difamilast group) before the start of the treatment in the remission maintenance phase,3.Patients who received systemic steroids, topical steroids (excluding the scalp) classified as `strongest` in the Japanese guidelines for atopic dermatitis, immunosuppressants, biological products, etc. within 26 weeks before the start of the treatment in the remission maintenance phase, 4.Patients who received phototherapy (UVB, narrow band UVB, PUVA, etc.) within 4 weeks before the start of the treatment in the remission maintenance phase, 5.Women who are pregnant or may possibly be pregnant and lactating women. Patients who wish to become pregnant during the research period, 6.Patients who have participated in a clinical trial or interventional clinical research within 4 weeks before the start of the treatment in the remission maintenance phase, 7.Patients with skin eruption with severe inflammation in >= 10% of body surface area within 4 weeks before the start of the treatment in the remission maintenance phase, 8.Patients whose treatment for atopic dermatitis was changed (discontinuation of the administration of the investigational drug, initiation of proactive therapy with TCSs or TCIs) during the period from the start of the treatment in the remission maintenance phase to the day of informed consent, 9.Other patients judged by the principal investigator to be ineligible for the research
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