Skip to main content
OpenTrials
Completed

NCT Number: NCT00616096

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dermatology, University of Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Immunoadsorption

Procedure

First cycle: week 1, day 1-5

Second cycle: week 5, day 1-5

Primary outcomes

  1. Evidence of clinical improvement of skin condition, pruritus and sleep disturbance.

    Time frame: 13 weeks

Secondary outcomes

  1. Evidence of reduction of concomitant topical and/or systemic medication.

    Time frame: 13 weeks

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 15, 2008
Registry last updated
Jan 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.