EUCTR2016-002351-16-DE进行中（未招募）1 期
An investigator-initiated, randomized, double-blind, placebo controlled study of Apremilast to demonstrate efficacy in subjects with nummular eczema - APREMINUM
Technische Universität München, Fakultät für Medizin, represented by Dean0 个研究点目标入组 40 人开始时间: 2016年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Confirmed diagnosis of NE with a PGA = 3 on a 5-point scale, biopsy-proven, age 18-85 years, body weight = 40 kg and = 160 kg, history of continuous use of topical steroids for the last 8 weeks, signed informed consent from patient.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Permanent severe diseases, especially those affecting the immune system, pregnancy or breast feeding, history or presence of epilepsy, significant neurological disorders, depression, suicidal ideation and behaviour, cerebrovascular attacks or ischemia, myocardial infarction or cardiac arrhythmia which requires drug therapy, evidence of severe renal dysfunction or significant hepatic disease, history of lymphoproliferative disorders .
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