Identifying Genetic Determinants of Eczema Herpeticum and Other Viral Infections in Individuals With Atopic Dermatitis

NCT ID: NCT00515047

Last Updated: 2014-04-02

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

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2011-01-31

Brief Summary

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People with atopic dermatitis (AD), or eczema, are susceptible to skin infections and inflammations. Some individuals with AD develop a condition known as eczema herpeticum (EH) following exposure to the herpes simplex virus (HSV). The purpose of this study is to identify the genetic determinants that lead people with AD to develop EH and similar conditions caused by other viruses.

Detailed Description

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AD is a chronic inflammatory skin disorder characterized by recurrent viral skin infections. However, people with AD do not all develop the same infections. For example, some people with AD who receive the smallpox vaccine develop a life-threatening condition known as eczema vaccinatum (EV). This study focuses on individuals with AD who also have a history of eczema herpeticum (ADEH+), a condition similar to EV. It is unlikely that the differences in the development of skin infections are due to differences in viral exposure, and instead due to differences in each individual's response to viruses. The purpose of this study is to determine the genetic pathways which are responsible for the development of viral skin infections in people with AD.

Participants in this study will also be enrolled in the ADVN Biomarker Registry Study. There will be only one clinical visit for this study at which blood and/or skin samples may be collected. The samples will then have high-throughput genotyping to define genetic markers in individuals susceptible to viral infections.

Conditions

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Atopic Dermatitis

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Eczema Herpeticum (EH)

Participants with AD who currently have or have had EH

No interventions assigned to this group

Non-EH

Participants with AD who do not have and have never had EH

No interventions assigned to this group

Healthy Controls

Healthy participants without a history of AD

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Enrollment in ADVN Biomarker Registry Study
* Non-Hispanic and only African American or only Caucasian race
* Parent or guardian willing to provide informed consent, if necessary

Exclusion Criteria

* History of any systemic illness, excluding AD
* Participation of a first degree relative already enrolled in the genotyping study unless the subject in question fulfills the diagnostic criteria for ADEH+. More information on this criterion can be found in the protocol.
Minimum Eligible Age

8 Months

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Beck, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Kathleen Barnes, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Allergy and Asthma Center

Locations

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University of California at San Diego

La Jolla, California, United States

Site Status

National Jewish Health

Denver, Colorado, United States

Site Status

Children's Memorial Hospital

Chicago, Illinois, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

Oregon Health & Sciences University

Portland, Oregon, United States

Site Status

Countries

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United States

References

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Baker BS. The role of microorganisms in atopic dermatitis. Clin Exp Immunol. 2006 Apr;144(1):1-9. doi: 10.1111/j.1365-2249.2005.02980.x.

Reference Type BACKGROUND
PMID: 16542358 (View on PubMed)

Kim BE, Leung DY, Streib JE, Kisich K, Boguniewicz M, Hamid QA, Howell MD. Macrophage inflammatory protein 3alpha deficiency in atopic dermatitis skin and role in innate immune response to vaccinia virus. J Allergy Clin Immunol. 2007 Feb;119(2):457-63. doi: 10.1016/j.jaci.2006.10.005. Epub 2006 Dec 4.

Reference Type BACKGROUND
PMID: 17141855 (View on PubMed)

Porter CD, Muhlemann MF, Cream JJ, Archard LC. Molluscum contagiosum: characterization of viral DNA and clinical features. Epidemiol Infect. 1987 Oct;99(2):563-6. doi: 10.1017/s0950268800068072.

Reference Type BACKGROUND
PMID: 2824227 (View on PubMed)

Umene K, Yoshida M, Sakaoka H. Comparison of the association with eczema herpeticum in the two predominant genotypes of herpes simplex virus type 1. J Med Virol. 1996 Aug;49(4):329-32. doi: 10.1002/(SICI)1096-9071(199608)49:43.0.CO;2-5.

Reference Type BACKGROUND
PMID: 8877767 (View on PubMed)

Gao PS, Leung DY, Rafaels NM, Boguniewicz M, Hand T, Gao L, Hata TR, Schneider LC, Hanifin JM, Beaty TH, Beck LA, Weinberg A, Barnes KC. Genetic variants in interferon regulatory factor 2 (IRF2) are associated with atopic dermatitis and eczema herpeticum. J Invest Dermatol. 2012 Mar;132(3 Pt 1):650-7. doi: 10.1038/jid.2011.374. Epub 2011 Nov 24.

Reference Type RESULT
PMID: 22113474 (View on PubMed)

Gao PS, Rafaels NM, Mu D, Hand T, Murray T, Boguniewicz M, Hata T, Schneider L, Hanifin JM, Gallo RL, Gao L, Beaty TH, Beck LA, Leung DY, Barnes KC. Genetic variants in thymic stromal lymphopoietin are associated with atopic dermatitis and eczema herpeticum. J Allergy Clin Immunol. 2010 Jun;125(6):1403-1407.e4. doi: 10.1016/j.jaci.2010.03.016. Epub 2010 May 13. No abstract available.

Reference Type RESULT
PMID: 20466416 (View on PubMed)

Related Links

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http://www.nationaljewish.org/adrn/index/

Click here for more information about the Atopic Dermatitis and Vaccinia Network

Other Identifiers

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HHSN266200400033

Identifier Type: -

Identifier Source: secondary_id

DAIT ADVN GENE 04

Identifier Type: -

Identifier Source: org_study_id

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