Identifying Risk Factors for Eczema Herpeticum in Individuals With Atopic Dermatitis

NCT00438022 | Completed DMC

• 2 other identifiers: DAIT ADVN ADEH 06HHSN266200400029C
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Eczema Herpeticum

Keywords

Atopic Dermatitis; Eczema Herpeticum

Outcome Measures

Primary Outcomes (1)

• Immunohistochemistry will be used to confirm the expression of IgE receptors and IgE binding of myeloid and plasmacytoid Dendritic Cells.

  3 years

Secondary Outcomes (5)

• 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

Study Arms (4)

1

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

2

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

3

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

4

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

People of good general health, living in Germany

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Atopic Dermatitis and Vaccinia Network: collaborator

Study Sites (1)

University of Bonn, Germany

Bonn, Germany

Location

Related Publications (2)

• Peng WM, Yu CF, Allam JP, Oldenburg J, Bieber T, Hoch J, Eis-Hubinger AM, Novak N. Inhibitory oligodeoxynucleotides downregulate herpes simplex virus-induced plasmacytoid dendritic cell type I interferon production and modulate cell function. Hum Immunol. 2007 Nov;68(11):879-87. doi: 10.1016/j.humimm.2007.10.008. Epub 2007 Nov 5.

  PMID: 18082566 RESULT

• Hinz T, Zaccaro D, Byron M, Brendes K, Krieg T, Novak N, Bieber T. Atopic dermo-respiratory syndrome is a correlate of eczema herpeticum. Allergy. 2011 Jul;66(7):925-33. doi: 10.1111/j.1398-9995.2010.02538.x. Epub 2011 Jan 24.

  PMID: 21255038 RESULT

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID) Website

Biospecimen

Retention: SAMPLES WITH DNA

Blood and skin samples will be retained

MeSH Terms

Conditions

Dermatitis, Atopic; Kaposi Varicelliform Eruption

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious

Study Officials

• Thomas Bieber, MD, PhD

  University of Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2007
• First Posted: February 21, 2007
• Study Start: March 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: October 6, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)