Treatment of AD With IgE Specific Immunoadsorption (IGEIAAD)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Interventional Trial With IgE-specific Immunoadsorption in Severe Atopic Dermatitis. Interventional Trial With IgE-specific Immunoadsorption in Severe Atopic Dermatitis.

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Device: immunoadsorptions with an IgE-specific adsorption column


Participation Criteria
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Eligibility Criteria
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Inclusion criteria 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immunoadsorption group<br>All patients will be treated with 10 immunoadsorptions with an IgE-specific adsorption column : | Device: immunoadsorptions with an IgE-specific adsorption column<br>* immunoadsorptions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical improvement (The improvement of Atopic dermatitis will be evaluated with different scales including SCORAD, EASI, LIS, DLQI) | The improvement of Atopic dermatitis will be evaluated with different scales including SCORAD, EASI, LIS, DLQI | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histological improvement and IgE tissue levels | we will evaluate the reduction of IgE and Fc epsilon RI expression in skin and total IgE in blood | one year | 
| Correlation between the therapeutic response and serum markers of disease activity . | we will evaluate serum levels and biomarkers such as TARC , MDC and TSLP during the course of the treatment | one year | 
| Effect of the treatment on positivity of skin prick tests. | we will evaluate skin prick reaction to dilution series of a previously positive allergen before and after treatment ) | one year | 
| Evaluation of length of improvement | we will evaluate the duration of improvement after the last immunoadsorption and investigate if there is a correlation with drop in total IgE and / or biomarkers. The/ usefulness of supplemental adsorptionsessions will be investigated if there is an indication. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atopic dermatitis, immunoadsorption