Identifying Risk Factors for Eczema Herpeticum in Individuals With Atopic Dermatitis

Study Overview
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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.

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.

Official Title
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Risk Factors in Atopic Dermatitis for the Development of Eczema Herpeticum

Conditions
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Atopic Dermatitis, Eczema Herpeticum

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Participants with AD: Diagnosis of AD as defined by ADVN standardized diagnostic criteria who fall into one of the following categories: Recurrent, clinically manifested HSV infection with EH Recurrent, clinically manifested HSV infection without EH 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Group 1 will include participants with AD, EH, and recurrent herpes simplex virus (HSV) | |
| 2<br>Group 2 will include participants with AD and recurring HSV infections but without EH | |
| 3<br>Group 3 will include participants with AD but without EH or HSV infection | |
| 4<br>Group 4 will include participants in good general health without AD, EH, or HSV infection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 phenotype of T-cells cocultured with HSV/CpG stimulated and unstimulated myeloid DCs or plasmacytoid DCs will be evaluated by flow cytometry. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis, Eczema Herpeticum