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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00616096

Enrollment

Registered

2008-02-15

Start date

2008-01-31

Completion date

2009-12-31

Last updated

2010-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatitis, Atopic

Keywords

Serum Immunoglobulin E above 5000 kU/l

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.

Interventions

PROCEDUREimmunoadsorption

First cycle: week 1, day 1-5 Second cycle: week 5, day 1-5

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
Evidence of clinical improvement of skin condition, pruritus and sleep disturbance.	13 weeks

Secondary

Measure	Time frame
Evidence of reduction of concomitant topical and/or systemic medication.	13 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026