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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immunoadsorption group | Experimental | All patients will be treated with 10 immunoadsorptions with an IgE-specific adsorption column : |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immunoadsorptions with an IgE-specific adsorption column | Device | immunoadsorptions |
|
| 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 |
| 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects of immunoadsorption | All side effects that appear during immunoadsorption or during the observation period after the last immunoadsorption will be recorded. | one year |
Inclusion criteria
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:
Having a malignant disease not under remission
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie-Anne C Morren, MD | Contact | 0032/16337009 | Marie-anne.morren@uzleuven.be | |
| Björn Meijers, PhD | Contact | 003216344580 | Bjorn.meijers@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Marie-Anne Morren, MD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20970174 | Result | Kasperkiewicz M, Schmidt E, Frambach Y, Rose C, Meier M, Nitschke M, Falk TM, Reich K, Ludwig RJ, Zillikens D. Improvement of treatment-refractory atopic dermatitis by immunoadsorption: a pilot study. J Allergy Clin Immunol. 2011 Jan;127(1):267-70, 270.e1-6. doi: 10.1016/j.jaci.2010.07.042. Epub 2010 Oct 20. No abstract available. |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |