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Identifying Genetic Determinants of Eczema Herpeticum and Other Viral Infections in Individuals With Atopic Dermatitis (Genetics)
This study is currently recruiting participants.
Verified by National Institute of Allergy and Infectious Diseases (NIAID), May 2009
First Received: August 10, 2007   Last Updated: May 26, 2009   History of Changes
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00515047
  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: 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

Biospecimen Description:

Skin scrapings and blood collection may occur


Estimated Enrollment: 1000
Study Start Date: May 2006
Estimated Study Completion Date: January 2010
Groups/Cohorts
1
People with AD will provide samples that will be exposed to HSV-1 to stimulate gene expression
2
People with AD will provide samples that will be exposed vaccinia to stimulate gene expression
3
People with AD will provide samples that will be exposed molluscum contagiosum to stimulate gene expression

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. To explore this objective, exposure to three viruses will be used to stimulate gene expression: HSV-1, vaccinia, and molluscum contagiosum.

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 be exposed to the viruses and high-throughput genotyping and gene expression profiling experiments will be used 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515047

Contacts
Contact: Judy Lairsmith (303) 270-2413 lairsmithj@NJHealth.org

Locations
United States, California
University of California at San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Doru Alexandrescu, MD     858-657-7192     dtalexandrescu@ucsd.edu    
Principal Investigator: Richard Gallo, MD, PhD            
Sub-Investigator: Tissa Hata, MD            
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Judy Lairsmith     303-270-2413     lairsmithj@NJHealth.org    
Principal Investigator: Donald Leung, MD, PhD            
Sub-Investigator: Mark Boguniewicz, MD            
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States
Contact: Reena Vaid     773-327-3326     rvaid@childrensmemorial.org    
Principal Investigator: Amy Paller, MD            
Children's Memorial Hospital Recruiting
Chicago, Illinois, United States
Contact: Reena Vaid     773-327-3326     rvaid@childrensmemorial.org    
Principal Investigator: Amy Paller            
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lisa Heughan     617-355-6127     lisa.heughan@childrens.harvard.edu    
Principal Investigator: Lynda Schneider, MD            
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Lorianne Stubbs     585-275-0374     Lorianne_Stubbs@urmc.rochester.edu    
Principal Investigator: Lisa Beck, MD            
United States, Oregon
Oregon Health & Sciences University Recruiting
Portland, Oregon, United States, 97239
Contact: Susan Tofte     503-494-6445     toftes@ohsu.edu    
Principal Investigator: Jon Hanifin, MD, PhD            
Sub-Investigator: Mark Slifka, PhD            
Sub-Investigator: Eric Simpson, MD            
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: DAIT/NIAID ( Associate Director, Clinical Research Program )
Study ID Numbers: DAIT ADVN GENE 04, HHSN266200400033
Study First Received: August 10, 2007
Last Updated: May 26, 2009
ClinicalTrials.gov Identifier: NCT00515047     History of Changes
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

Study placed in the following topic categories:
Herpes Simplex
Dermatitis, Atopic
Skin Diseases
Vaccinia
Eczema
Herpesviridae Infections
Virus Diseases
Kaposi Varicelliform Eruption
Exanthema
Skin Diseases, Infectious
Hypersensitivity
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Skin Diseases, Eczematous
DNA Virus Infections
Skin Diseases, Genetic
Dermatitis

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

ClinicalTrials.gov processed this record on September 04, 2009