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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00515047
First received: August 10, 2007
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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
Atopic Dermatitis

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Genetics of Atopic Dermatitis - Eczema Herpeticum

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Identification of variants/haplotypes in EH-associated genes and characterization of frequencies of variants in priority candidate genes for EH [ Time Frame: Throughout Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identification and prioritization of novel genes induced in response to viral infection (HSV/Vaccinia and MCV) in AD participants and relevant control groups [ Time Frame: Throughout Study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Skin scrapings and blood collection may occur


Enrollment: 900
Study Start Date: May 2006
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   8 Months to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

African-American, Caucasian, and Non-Hispanic people ages 8 months to 80 years

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515047

Locations
United States, California
University of California at San Diego
La Jolla, California, United States, 92037
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Illinois
Northwestern University
Chicago, Illinois, United States
Children's Memorial Hospital
Chicago, Illinois, United States
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Oregon
Oregon Health & Sciences University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Investigators
Principal Investigator: Lisa Beck, MD University of Rochester
Principal Investigator: Kathleen Barnes, PhD Johns Hopkins Allergy and Asthma Center
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00515047     History of Changes
Other Study ID Numbers: DAIT ADVN GENE 04, HHSN266200400033
Study First Received: August 10, 2007
Last Updated: April 1, 2014
Health Authority: United States: Federal Government

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:
Dermatitis
Dermatitis, Atopic
Kaposi Varicelliform Eruption
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious

ClinicalTrials.gov processed this record on September 18, 2014