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

January 27, 2010 updated by: University of Luebeck
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Department of Dermatology, University of Lübeck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Procedure: immunoadsorption

First cycle: week 1, day 1-5

Second cycle: week 5, day 1-5

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Evidence of reduction of concomitant topical and/or systemic medication.
Time Frame: 13 weeks
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Investigators

  • Study Chair: Detlef Zillikens, M. D., Department of Dermatology, University of Lübeck, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

February 4, 2008

First Submitted That Met QC Criteria

February 5, 2008

First Posted (Estimate)

February 15, 2008

Study Record Updates

Last Update Posted (Estimate)

January 28, 2010

Last Update Submitted That Met QC Criteria

January 27, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAAD01
  • AZ07-111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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