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

This study has been completed.
Sponsor:
Information provided by:
University of Luebeck
ClinicalTrials.gov Identifier:
NCT00616096
First received: February 4, 2008
Last updated: January 27, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention
Dermatitis, Atopic
Procedure: immunoadsorption

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Immunoadsorption to Treat Severe Atopical Dermatitis Associated With Excessively High Serum IgE Levels

Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • Evidence of clinical improvement of skin condition, pruritus and sleep disturbance. [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evidence of reduction of concomitant topical and/or systemic medication. [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: immunoadsorption

First cycle: week 1, day 1-5

Second cycle: week 5, day 1-5


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616096

Locations
Germany
Department of Dermatology, University of Lübeck
Lübeck, Schleswig-Holstein, Germany, 23538
Sponsors and Collaborators
University of Luebeck
Investigators
Study Chair: Detlef Zillikens, M. D. Department of Dermatology, University of Lübeck, Germany
  More Information

No publications provided

Responsible Party: Detlef Zillikens, M. D., Department of Dermatology, University of Lübeck, Germany
ClinicalTrials.gov Identifier: NCT00616096     History of Changes
Other Study ID Numbers: IAAD01, AZ07-111
Study First Received: February 4, 2008
Last Updated: January 27, 2010
Health Authority: Germany: Ethics Commission
Germany: German Institute of Medical Documentation and Information

Keywords provided by University of Luebeck:
Serum Immunoglobulin E above 5000 kU/l

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014