Study of Immunoadsorption to Treat Severe Atopical Dermatitis Associated With Excessively High Serum IgE Levels

University of Luebeck

Status

Completed

Conditions

Dermatitis, Atopic

Treatments

Procedure: immunoadsorption

Study type

Interventional

Funder types

Other

Identifiers

NCT00616096

IAAD01

AZ07-111

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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)