JPRN-jRCT2031210255已完成3 期
Phase 3 Clinical Study of JTE-061 Cream - Randomized Vehicle-controlled Study (Part 1) and Extension Study (Part 2) in Patients with Atopic Dermatitis
emoto Takanori0 个研究点目标入组 216 人开始时间: 2021年8月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
研究概览
简要总结
When JTE-061 cream 1% was administered once daily for 8 weeks to patients with AD, improvements in the IGA, EASI, %BSA affected, pruritus NRS, and Skindex-16 were noted as compared to the vehicle cream. When JTE-061 cream 1% was administered once daily for up to 24 weeks to patients with AD, the plasma concentration was low, and treatment with JTE-061 was generally safe. The efficacy of JTE-061 cream 1% in the treatment of AD was maintained for up to 24 weeks.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 12age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Japanese patients aged >= 12 years at informed consent who can visit the study site as an outpatient
- •2. Patients with clinical diagnosis of AD according to the criteria of the Japanese Dermatological Association prior to or at informed consent
- •3. Patients whose IGA score, EASI score, and %BSA affected meet the criteria specified in the study protocol
排除标准
- •1. Patients with a history of or current significant dermatologic or inflammatory condition that, in the investigator's opinion, would make it difficult to interpret data or assessments during the study
- •2. Patients with a history of or current acute active bacterial, fungal, or viral (e.g., herpes simplex, herpes zoster, and varicella))skin infection within 1 week prior to Week 0
- •3. Patients who have used any prohibited therapy specified in the study protocol within the indicated period before Week 0
- •4. Patients with serious concomitant disease(s)
- •5. Patients with a history of or current cancer within 5 years prior to screening visit
研究者
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