Identifying Risk Factors for Eczema Herpeticum in Individuals With Atopic Dermatitis

National Institute of Allergy and Infectious Diseases (NIAID)

Status

Completed

Conditions

Atopic Dermatitis

Eczema Herpeticum

Study type

Observational

Funder types

NETWORK

NIH

Identifiers

NCT00438022

DAIT ADVN ADEH 06

HHSN266200400029C (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

240 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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
Individuals between 18-60 years of age

Exclusion Criteria for All Participants:

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