search
Back to results

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

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
immunoadsorption
Sponsored by
University of Luebeck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Serum Immunoglobulin E above 5000 kU/l

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Dermatology, University of Lübeck

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 4, 2008
Last Updated
January 27, 2010
Sponsor
University of Luebeck
search

1. Study Identification

Unique Protocol Identification Number
NCT00616096
Brief Title
Study of Immunoadsorption to Treat Severe Atopical Dermatitis Associated With Excessively High Serum IgE Levels
Official Title
Study of Immunoadsorption to Treat Severe Atopical Dermatitis Associated With Excessively High Serum IgE Levels
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Luebeck

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Serum Immunoglobulin E above 5000 kU/l

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
immunoadsorption
Intervention Description
First cycle: week 1, day 1-5 Second cycle: week 5, day 1-5
Primary Outcome Measure Information:
Title
Evidence of clinical improvement of skin condition, pruritus and sleep disturbance.
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Evidence of reduction of concomitant topical and/or systemic medication.
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Detlef Zillikens, M. D.
Organizational Affiliation
Department of Dermatology, University of Lübeck, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Dermatology, University of Lübeck
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs