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

April 1, 2014 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Genetics of Atopic Dermatitis - Eczema Herpeticum

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • University of California at San Diego
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Illinois
      • Chicago, Illinois, United States
        • Northwestern University
      • Chicago, Illinois, United States
        • Children's Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Sciences University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identification of variants/haplotypes in EH-associated genes and characterization of frequencies of variants in priority candidate genes for EH
Time Frame: Throughout Study
Throughout Study

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Throughout Study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

August 10, 2007

First Submitted That Met QC Criteria

August 10, 2007

First Posted (Estimate)

August 13, 2007

Study Record Updates

Last Update Posted (Estimate)

April 2, 2014

Last Update Submitted That Met QC Criteria

April 1, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAIT ADVN GENE 04
  • HHSN266200400033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atopic Dermatitis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe