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

Atopic Dermatitis Clinical Trial

— Genetics  

Official title:

Genetics of Atopic Dermatitis - Eczema Herpeticum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00515047
• Other study ID #: DAIT ADVN GENE 04
• Secondary ID: HHSN266200400033
• Status: Completed
• Phase: N/A
• First received: August 10, 2007
• Last updated: April 1, 2014
• Start date: May 2006
• Est. completion date: January 2011

Study information

• Verified date: April 2014
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Months to 80 Years

Eligibility

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.

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Children's Memorial Hospital	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	National Jewish Health	Denver	Colorado
United States	University of California at San Diego	La Jolla	California
United States	Oregon Health & Sciences University	Portland	Oregon
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Baker BS. The role of microorganisms in atopic dermatitis. Clin Exp Immunol. 2006 Apr;144(1):1-9. Review. — View Citation

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. — View Citation

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 herpetic — View Citation

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. Epub 2006 Dec 4. Erratum in: J Allergy Clin Immunol. 2008 Nov;122(5):1007.. Kisich, Kevin [added]. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of variants/haplotypes in EH-associated genes and characterization of frequencies of variants in priority candidate genes for EH		Throughout Study	No
Secondary	Identification and prioritization of novel genes induced in response to viral infection (HSV/Vaccinia and MCV) in AD participants and relevant control groups		Throughout Study	No

External Links

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