Interventional Trial With IgE-specific Immunoadsorption in Severe Atopic Dermatitis. Interventional Trial With IgE-specific Immunoadsorption in Severe Atopic Dermatitis.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- clinical improvement (The improvement of Atopic dermatitis will be evaluated with different scales including SCORAD, EASI, LIS, DLQI)
研究概览
简要总结
Removal of IgE through adsorption of IgE on a specially designed column after apheresis of blood has the potential to improve the severity of atopic dermatitis.
In this study the investigators will treat patients with a severe form of Atopic dermatitis not responding or having to much side effects to systemic imunosuppressive treatment with this modality.
详细描述
Patients will be treated with immunoadsorption on 4 consecutive days week 1 and three consecutive days week 5 and week 9.
The clinical improvement and histological and serological tests will be evaluated.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (> 18 year) with severe atopic dermatitis (objective SCORAD > 40)
- •Who's AD is persistent and stable since more than 1 year
- •Who signed the informed consent
- •Who are not pregnant or do not plan to become pregnant, during the immunoadsorption treatment
- •Who were treated in the recent past with phototherapy or immunosuppressive therapy ( one or more : cyclosporin A, methotrexate , azathioprine , mycophenolate , systemic corticosteroids ) and where this therapy was not sufficiently helpful, had unacceptable side effects or are contraindicated
排除标准
- •Patients who did not give an informed consent.
- •Patients with mild or moderate AD.
- •Patients with severe AD improving with, and tolerating, standard therapy (including phototherapy, short periods of corticosteroids, the above mentioned immunosuppressive therapies ) and having no contra-indications for these therapies
- •Pregnant women and female patients willing to become pregnant during the planned period of treatment or immediately after.
- •Having contra-indications for immunoadsorption:
- •Patients with a known allergy for the material used during immunoadsorption.
- •Severe cardiovascular diseases.
- •Severe bleeding during anticoagulation .
- •Treated with ACE-inhibitors.
- •Patients younger than18 years.
- •Having a malignant disease not under remission
研究组 & 干预措施
immunoadsorption group
All patients will be treated with 10 immunoadsorptions with an IgE-specific adsorption column :
干预措施: immunoadsorptions with an IgE-specific adsorption column (Device)
结局指标
主要结局
clinical improvement (The improvement of Atopic dermatitis will be evaluated with different scales including SCORAD, EASI, LIS, DLQI)
时间窗: one year
The improvement of Atopic dermatitis will be evaluated with different scales including SCORAD, EASI, LIS, DLQI
次要结局
- histological improvement and IgE tissue levels(one year)
- Correlation between the therapeutic response and serum markers of disease activity .(one year)
- Effect of the treatment on positivity of skin prick tests.(one year)
- Evaluation of length of improvement(one year)