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

Dermatitis, Atopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616096
• Other study ID #: IAAD01
• Secondary ID: AZ07-111
• Status: Completed
• Phase: N/A
• First received: February 4, 2008
• Last updated: January 27, 2010
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Procedure:
• immunoadsorption
First cycle: week 1, day 1-5 Second cycle: week 5, day 1-5

Locations

Country	Name	City	State
Germany	Department of Dermatology, University of Lübeck	Lübeck	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of clinical improvement of skin condition, pruritus and sleep disturbance.		13 weeks	Yes
Secondary	Evidence of reduction of concomitant topical and/or systemic medication.		13 weeks	Yes