Identifying Risk Factors for Eczema Herpeticum in Individuals With Atopic Dermatitis - Tabular View

Tracking Information

First Received Date ^ICMJE

February 20, 2007

Last Updated Date

July 28, 2009

Start Date ^ICMJE

March 2006

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Immunohistochemistry will be used to confirm the expression of IgE receptors and IgE binding of myeloid and plasmacytoid Dendrytic Cells. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00438022 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Identifying Risk Factors for Eczema Herpeticum in Individuals With Atopic Dermatitis

Official Title ^ICMJE

Risk Factors in Atopic Dermatitis for the Development of Eczema Herpeticum

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 and recurrent herpes simplex virus (HSV)
Group 2 will include participants with 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 Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case Control, Prospective

Condition ^ICMJE

Atopic Dermatitis
Eczema Herpeticum

Intervention ^ICMJE

Study Arms / Comparison Groups

Group 1 will include participants with AD and recurrent herpes simplex virus (HSV)
Group 2 will include participants with 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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

240

Completion Date

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria for Participants with AD:

Diagnosis of AD as defined by ADVN standardized diagnostic criteria who fall into one of the following categories:
1. Recurrent, clinically manifested HSV infection with EH
2. Recurrent, clinically manifested HSV infection without EH
3. No recurrent, clinically manifested HSV infection or EH infection

Inclusion Criteria for All Participants

Residing in Germany
Good general health other than having an atopic disease
Caucasian

Exclusion Criteria for All Participants:

Systemic immunosuppressive drugs or chemotherapy 30 days prior to study entry
Oral and topical corticosteroids (including inhaled agents), antibiotics, antivirals, anti-inflammatory biologics (e.g., alfacept, etanercept), topical doxepin, topical coal tar preparations, or topical phosphodiesterase inhibitors 14 days prior to study entry
Immunotherapy
Antibiotics, antivirals, immune enhancers (e.g., imiquimod), or calcineurin inhibitors within 7 days prior to study entry
Phototherapy (e.g., ultraviolet light B [UVB], psoralen plus ultraviolet light A [PUVA]) 30 days prior to study entry
Cancer, autoimmune diseases, or immunodeficiency
Active fungal, bacterial, or viral infections at screening
Any skin diseases other than AD that might compromise the stratum corneum barrier (e.g., ichthyosis, bullous disease, psoriasis, skin cancer)
Mental illness or a history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements
Weigh less than 40 kg (88.2 lb)
Anxiolytic agents
Antidepressants
Pregnancy or breastfeeding

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Thomas Bieber, MD, PhD	+49-228-287-1-4388	Thomas.Bieber@ukb.uni-bonn.de
Contact: Natalija Novak, MD	+49-228-287-1-5370	Natalija.Novak@ukb.uni-bonn.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00438022

Responsible Party

Associate Director, Clinical Research Program, DAIT/NIAID

Study ID Numbers ^ICMJE

DAIT ADVN ADEH 06, Contract No. HHSN266200400029C

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Thomas Bieber, MD, PhD

University of Bonn, Germany

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP