Identifying Risk Factors for Eczema Herpeticum in Individuals With Atopic Dermatitis

Completed

• Conditions: Eczema Herpeticum; Atopic Dermatitis

• Registration Number: NCT00438022
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

Atopic Dermatitis (AD), also known as eczema, is a skin disease that causes the skin to be hot, dry and scaly, and have severe itching. There are different kinds of eczema. Eczema herpeticum (EH) is a type of eczema that spreads due to an underlying herpes virus infection. The purpose of this research study is to identify the risk factors that may cause EH.

Detailed Description

AD is characterized by chronic skin inflammation and infections. It is hypothesized that AD is caused by irritants in the environment and that symptoms of EH become worse with stress and changes in hormone levels. This study will examine skin cells collected from study participants to determine the risk factors for EH that are present in people with AD who develop EH.

This study will examine dendritic cells (DC) from the skin and blood of study participants to determine the differences between DCs of study participants. This study will recruit four types of participants:

* Group 1 will include participants with AD, EH, and recurrent herpes simplex virus (HSV)

* Group 2 will include participants with AD and recurring HSV infections but without EH

* Group 3 will include participants with AD but without EH or HSV infection

* Group 4 will include participants in good general health without AD, EH, or HSV infection

At the single study visit, skin and blood collection will occur.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2007-02-20
• Study First Submitted QC: 2007-02-20
• Study First Posted: 2007-02-21
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunohistochemistry will be used to confirm the expression of IgE receptors and IgE binding of myeloid and plasmacytoid Dendritic Cells.	3 years

Secondary Outcome Measures

Name	Time	Method
The capacity of myeloid and plasmacytoid DCs to produce IFN-α/IFN-β and of myeloid DCs to produce IL-10, IL-12, and IL-18 will be evaluated.	3 years
Expression of HSV-receptors cluster of differentiation, costimulatory molecules, major histocompatibility complex, Toll-like receptor (TLR), and structures involved in antigen presentation of myeloid and plasmacytoid DCs.	3 years
Evaluate the capacity of T-cells, stimulated and unstimulated myeloid DCs or plasmacytoid DCs to produce the T-helper cell 2 (Th2) cytokines IL-4, IL-5 and IL-13 and the T-helper cell 1 (Th1) cytokines IL-2 and IFN-γ and IL-10/TGF-β.	3 years
The proliferation of T-cells cocultured with HSV/CpG stimulated and unstimulated myeloid DCs or plasmacytoid DCs will be measured with the help of flow cytometry by proliferating cell nuclear antigen.	3 years
The phenotype of T-cells cocultured with HSV/CpG stimulated and unstimulated myeloid DCs or plasmacytoid DCs will be evaluated by flow cytometry.	3 years

Trial Locations

Locations (1)

University of Bonn, Germany; 🇩🇪 Bonn, Germany