Identifying Risk Factors for Eczema Herpeticum in Individuals With Atopic Dermatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atopic Dermatitis Eczema Herpeticum

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

No interventions assigned to this group

2

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

No interventions assigned to this group

3

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

No interventions assigned to this group

4

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

* Residing in Germany
* Good general health other than having an atopic disease
* Caucasian
* Individuals between 18-60 years of age

Exclusion Criteria

* Subjects with atopy but lacking stringent AD features, allowing only a presumptive diagnosis of AD
* Individuals under 18 or over 60 years of age
* 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., alefacept, 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
* Inability or unwillingness of a subject to give written informed consent
* Weigh less than 40 kg (88.2 lb)
* Anxiolytic agents
* Antidepressants
* Pregnancy or breastfeeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes