Status:
COMPLETED
Study of Immunoadsorption to Treat Severe Atopical Dermatitis Associated With Excessively High Serum IgE Levels
Lead Sponsor:
University of Luebeck
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether immunoadsorption is effective in the treatment of severe atopic dermatitis associated with excessively high serum IgE levels.
Eligibility Criteria
Inclusion
- Atopical dermatitis
- Total serum IgE level above 5000 kU/l
- IGA score of 3 or above
- No sufficient response to topical corticosteroids/calcineurin inhibitors, UV therapy (at least 4 weeks of therapy), systemic corticosteroids and cyclosporin A (at least 8 weeks of therapy) or no possibility of a prolonged use of this therapy due to adverse events/contraindications
- 18 years of age or above
- Effective contraception during therapy
- Informed consent
Exclusion
- Unfavorable conditions for peripheral venous access
- Known hypersensitivity or allergy towards materials used in the adsorber columns
- Adequate anticoagulation not possible (e.g. multiple allergies towards various anticoagulants)
- Extreme bleeding tendency during anticoagulation
- Hypercoagulability
- Severe cardiovascular disease forbidding extracorporeal circulation
- Severe systemic infection
- Serum IgG level below 250 mg/dl
- Severe immunodeficiency (e.g. AIDS)
- Treatment with an ACE inhibitor (discontinue drug at least 72 h before treatment)
- Pregnancy
- Lactation
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism or mental dysfunction)
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00616096
Start Date
January 1 2008
End Date
December 1 2009
Last Update
January 28 2010
Active Locations (1)
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1
Department of Dermatology, University of Lübeck
Lübeck, Schleswig-Holstein, Germany, 23538