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

Not Applicable

Completed

• Conditions: Dermatitis, Atopic
• Interventions: Procedure: immunoadsorption

• Registration Number: NCT00616096
• Lead Sponsor: University of Luebeck

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-04
• Study First Submitted QC: 2008-02-05
• Study First Posted: 2008-02-15
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-27
• Last Update Posted: 2010-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	immunoadsorption	-

Primary Outcome Measures

Name	Time	Method
Evidence of clinical improvement of skin condition, pruritus and sleep disturbance.	13 weeks

Secondary Outcome Measures

Name	Time	Method
Evidence of reduction of concomitant topical and/or systemic medication.	13 weeks

Trial Locations

Locations (1)

Department of Dermatology, University of Lübeck; 🇩🇪 Lübeck, Schleswig-Holstein, Germany