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

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00515047
• Collaborator: (none)
• Enrollment: 900
• Locations: 7
• Duration (Months): 56
• Patients Per Site: 128.6
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 900 participants
• Time Perspective: Cross-Sectional
• Official Title: Genetics of Atopic Dermatitis - Eczema Herpeticum
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Eczema Herpeticum (EH) Participants with AD who currently have or have had EH
Non-EH Participants with AD who do not have and have never had EH
Healthy Controls Healthy participants without a history of AD

Outcome Measures

Primary Outcome Measures

1. Identification of variants/haplotypes in EH-associated genes and characterization of frequencies of variants in priority candidate genes for EH [Throughout Study]

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Months to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California at San Diego	La Jolla	California	United States	92037
2	National Jewish Health	Denver	Colorado	United States	80206
3	Children's Memorial Hospital	Chicago	Illinois	United States
4	Northwestern University	Chicago	Illinois	United States
5	Children's Hospital Boston	Boston	Massachusetts	United States	02115
6	University of Rochester Medical Center	Rochester	New York	United States	14642
7	Oregon Health & Sciences University	Portland	Oregon	United States	97239

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: Lisa Beck, MD, University of Rochester
• Principal Investigator: Kathleen Barnes, PhD, Johns Hopkins Allergy and Asthma Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

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

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT00515047
• Other Study ID Numbers: DAIT ADVN GENE 04; HHSN266200400033
• First Posted: Aug 13, 2007
• Last Update Posted: Apr 2, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID): Atopic Dermatitis; Eczema; Eczema Herpeticum; Molluscum Contagiousum; Herpes Simplex; Vaccinia
• Additional relevant MeSH terms: Kaposi Varicelliform Eruption; Dermatitis, Atopic; Dermatitis; Eczema

Study Results

No Results Posted as of Apr 2, 2014