JPRN-jRCT2031210257已完成2 期
Phase 2 Clinical Study of JTE-061 Cream - Efficacy and Safety Study in Pediatric Patients with Atopic Dermatitis
emoto Takanori0 个研究点目标入组 121 人开始时间: 2021年8月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
研究概览
简要总结
When JTE-061 cream 0.5% or 1% was administered once a daily for 8 weeks to pediatric patients with AD, improvements in the EASI score, IGA score, %BSA affected, and pruritus score were noted in both the 0.5% and 1% groups compared to the vehicle group. The plasma concentration of JTE-061 was low, and treatment with JTE-061 was generally safe.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 2age old 至 <= 11age old（—）
- 性别
- All
入选标准
- •1. Japanese patients aged between 2 and 11 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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