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

NCT00616096 | Completed

• 2 other identifiers: IAAD01AZ07-111
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis, Atopic

Keywords

Serum Immunoglobulin E above 5000 kU/l

Outcome Measures

Primary Outcomes (1)

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

  13 weeks

Secondary Outcomes (1)

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

  13 weeks

Study Arms (1)

1

EXPERIMENTAL

Procedure: immunoadsorption

Interventions

immunoadsorption PROCEDURE

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or above
• Effective contraception during therapy
• Informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Luebeck: lead

Study Sites (1)

Department of Dermatology, University of Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Plasmapheresis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Detlef Zillikens, M. D.

  Department of Dermatology, University of Lübeck, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 15, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 28, 2010

Record last verified: 2010-01

Locations

DE (1)