jRCT2011210062已完成不适用
Pharmacodynamic Study of JTE-061 Cream - Pharmacodynamic Effects of JTE-061 Cream in Patients with Atopic Dermatitis -
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Mean change in SCH of the target affected area from Baseline at Week 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •<Patients with AD>
- •Japanese patients aged >=20 years at informed consent who can visit the study site as an outpatient
- •Patients with clinical diagnosis of AD according to the criteria of the Japanese Dermatological Association prior to or at informed consent
- •Patients whose Investigator's Global Assessment (IGA) score, affected area, Stratum Corneum Hydration (SCH), and Transepidermal Water Loss (TEWL) of the target affected area meet the criteria specified in the study protocol
- •<Healthy adults>
- •Healthy Japanese men and women aged >= 20 years at informed consent
排除标准
- •<Patients with AD>
- •Patients with a current significant dermatologic or inflammatory condition that, in the investigator's opinion, would make it difficult to interpret data or assessments during the study
- •Patients with a history of or current acute active bacterial, fungal, or viral (eg, herpes simplex, herpes zoster, and chicken pox) skin infection on the forearm with the target area within 1 week prior to Week
- •Patients who have used any prohibited therapy specified in the study protocol within the indicated period before Week 0
- •Patients with serious concomitant disease(s)
- •Patients with a history of or current cancer within 5 years prior to screening visit
- •<Healthy adults>
- •Persons with serious concomitant disease(s)
- •Persons with a skin condition such as eczema, dermatitis, xeroderma, pigmentation disorder, skin inflammation due to sunburn, trauma, or scars on the forearm with the target area that may affect the assessments of the study
- •Persons with a history of or current contact dermatitis, mechanical urticaria, or cutaneous hypersensitivity caused by topical agent or adhesive plasters or tapes, or atopic dermatitis that may affect the assessments of the study
- •Persons who have used a topical agent on the forearm with the target area within 1 week prior to the assessment visit
结局指标
主要结局
Mean change in SCH of the target affected area from Baseline at Week 8
时间窗: Week 8
Mean change in **SCH** of the target affected area from Baseline
Mean change in TEWL of the target affected area from Baseline at Week 8
时间窗: Week 8
Mean change in **TEWL** of the target affected area from Baseline
次要结局
未报告次要终点
研究者
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