Atopic Dermatitis
Conditions
Keywords
atopic dermatitis, immunoadsorption
Brief summary
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
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.
Interventions
DEVICEimmunoadsorptions with an IgE-specific adsorption column
immunoadsorptions
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical improvement (The improvement of Atopic dermatitis will be evaluated with different scales including SCORAD, EASI, LIS, DLQI) | one year | The improvement of Atopic dermatitis will be evaluated with different scales including SCORAD, EASI, LIS, DLQI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| histological improvement and IgE tissue levels | one year | we will evaluate the reduction of IgE and Fc epsilon RI expression in skin and total IgE in blood |
| Correlation between the therapeutic response and serum markers of disease activity . | one year | we will evaluate serum levels and biomarkers such as TARC , MDC and TSLP during the course of the treatment |
| Effect of the treatment on positivity of skin prick tests. | one year | we will evaluate skin prick reaction to dilution series of a previously positive allergen before and after treatment ) |
| Evaluation of length of improvement | one year | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Side effects of immunoadsorption | one year | All side effects that appear during immunoadsorption or during the observation period after the last immunoadsorption will be recorded. |
Countries
Belgium
Contacts
Primary ContactMarie-Anne C Morren, MD
Backup ContactBjörn Meijers, PhD
Outcome results
None listed