Treatment of AD With IgE Specific Immunoadsorption (IGEIAAD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2025-12-31

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.

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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.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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immunoadsorption group

All patients will be treated with 10 immunoadsorptions with an IgE-specific adsorption column :

Group Type EXPERIMENTAL

immunoadsorptions with an IgE-specific adsorption column

Intervention Type DEVICE

immunoadsorptions

Interventions

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immunoadsorptions with an IgE-specific adsorption column

immunoadsorptions

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adults (\> 18 year) with severe atopic dermatitis (objective SCORAD \> 40)
2. Who's AD is persistent and stable since more than 1 year
3. Who signed the informed consent
4. Who are not pregnant or do not plan to become pregnant, during the immunoadsorption treatment
5. 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

1. Patients who did not give an informed consent.
2. Patients with mild or moderate AD.
3. 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
4. Pregnant women and female patients willing to become pregnant during the planned period of treatment or immediately after.
5. 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.
6. Having a malignant disease not under remission

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No