NCT00616096已完成不适用
Study of Immunoadsorption to Treat Severe Atopical Dermatitis Associated With Excessively High Serum IgE Levels
University of Luebeck2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2008年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Evidence of clinical improvement of skin condition, pruritus and sleep disturbance.
研究概览
简要总结
The purpose of this study is to determine whether immunoadsorption is effective in the treatment of severe atopic dermatitis associated with excessively high serum IgE levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atopical dermatitis
- •Total serum IgE level above 5000 kU/l
- •IGA score of 3 or above
- •No sufficient response to topical corticosteroids/calcineurin inhibitors, UV therapy (at least 4 weeks of therapy), systemic corticosteroids and cyclosporin A (at least 8 weeks of therapy) or no possibility of a prolonged use of this therapy due to adverse events/contraindications
- •18 years of age or above
- •Effective contraception during therapy
- •Informed consent
排除标准
- •Unfavorable conditions for peripheral venous access
- •Known hypersensitivity or allergy towards materials used in the adsorber columns
- •Adequate anticoagulation not possible (e.g. multiple allergies towards various anticoagulants)
- •Extreme bleeding tendency during anticoagulation
- •Hypercoagulability
- •Severe cardiovascular disease forbidding extracorporeal circulation
- •Severe systemic infection
- •Serum IgG level below 250 mg/dl
- •Severe immunodeficiency (e.g. AIDS)
- •Treatment with an ACE inhibitor (discontinue drug at least 72 h before treatment)
- •Pregnancy
- •Lactation
- •A condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism or mental dysfunction)
结局指标
主要结局
Evidence of clinical improvement of skin condition, pruritus and sleep disturbance.
时间窗: 13 weeks
次要结局
- Evidence of reduction of concomitant topical and/or systemic medication.(13 weeks)
研究者
研究点 (2)
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