JPRN-jRCT2011210062已完成1 期
Pharmacodynamic Study of JTE-061 Cream - Pharmacodynamic Effects of JTE-061 Cream in Patients with Atopic Dermatitis
emoto Takanori0 个研究点目标入组 40 人开始时间: 2022年1月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
When JTE-061 cream 1% was administered once a adaily for 8 weeks to patients with AD, improvements in SCH and TEWL of the target affected area were noted. The study results suggest that treatment with JTE-061 cream improves skin barrier function in patients with AD.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Japanese patients aged >=20 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 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
- •1. Healthy Japanese men and women aged >= 20 years at informed consent
排除标准
- •1. 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
- •2. 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 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
- •1. Persons with serious concomitant disease(s)
- •2. 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
- •3. 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
- •4. Persons who have used a topical agent on the forearm with the target area within 1 week prior to the assessment visit
研究者
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