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) in response to 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

MedlinePlus related topics:   Eczema   Herpes Simplex  

ChemIDplus related topics:   PANVAC-V  

U.S. FDA Resources

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

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

Primary Outcome Measures:
  • The identification of variants/haplotypes in candidate genes associated with EH and the characterization of frequencies of variants in priority candidate genes for EH according to African American and Caucasian race. [ Time Frame: 4 years ]

Secondary Outcome Measures:
  • The identification and prioritization of novel genes induced in response to viral infection (HSV/Vaccinia and MCV) in AD subjects and relevant control groups. [ Time Frame: 4 years ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Skin scrapings and blood collection will occur


Estimated Enrollment:   1000
Study Start Date:   May 2006
Estimated Study Completion Date:   May 2009

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). The focus of this study is individuals with AD who have a history of EH (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, but instead due to differences in each individual's response to viruses. The purpose of this study is to determine what genetic pathways are responsible for the development of viral skin infections in people with AD using exposure to three viruses: HSV-1, vaccinia, and molluscum contagiosum to stimulate gene expression.

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 skin samples will 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:   1 Year to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample

Study Population

African-American, Caucasion, and Non-Hispanic people ages 1 to 80


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 other than AD.
  • Participation of a first degree relative (defined as siblings, half siblings, and parents) already enrolled in the genotyping study unless the subject in question fulfills the diagnostic criteria for ADEH . If a second family member is enrolled because they are ADEH , then the first family member that was enrolled will be removed from the study (if they are not ADEH ).
  Contacts and Locations

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

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

Locations
United States, California
University of California at San Diego     Recruiting
      La Jolla, California, United States, 92037
      Contact: Michelle Jackson, MD     858-657-7192     m5jackson@ucsd.edu    
      Principal Investigator: Richard Gallo, MD, PhD            
      Sub-Investigator: Tissa Hata, MD            
United States, Colorado
National Jewish Medical & Research Center     Recruiting
      Denver, Colorado, United States, 80206
      Contact: Judy Lairsmith     303-270-2413     lairsmithj@njc.org    
      Principal Investigator: Donald Leung, MD, PhD            
      Sub-Investigator: Mark Boguniewicz, MD            
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    
Contact: Judy Lairsmith     (303) 270-2413     lairsmithj@njc.org    
United States, California
University of California at San Diego     Recruiting
      La Jolla, California, United States, 92037
      Contact: Michelle Jackson, MD     858-657-7192     m5jackson@ucsd.edu    
      Principal Investigator: Richard Gallo, MD, PhD            
      Sub-Investigator: Tissa Hata, MD            
United States, Colorado
National Jewish Medical & Research Center     Recruiting
      Denver, Colorado, United States, 80206
      Contact: Judy Lairsmith     303-270-2413     lairsmithj@njc.org    
      Principal Investigator: Donald Leung, MD, PhD            
      Sub-Investigator: Mark Boguniewicz, MD            
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            
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator:     Lisa Beck, MD     University of Rochester    
  More Information

Click here for more information about the Atopic Dermatitis and Vaccinia Network  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   ADVN GENE 04, HHSN266200400033
First Received:   August 10, 2007
Last Updated:   November 8, 2007
ClinicalTrials.gov Identifier:   NCT00515047
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
Vaccinia
Eczema
Herpesviridae Infections
Kaposi Varicelliform Eruption
Exanthema
Skin Diseases, Infectious
Hypersensitivity
Hypersensitivity, Immediate
Skin Diseases, Eczematous
DNA Virus Infections
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:
Skin Diseases, Viral
Virus Diseases
Immune System Diseases
Genetic Diseases, Inborn
Skin Diseases
Dermatitis, Atopic

Source: National Library of Medicine (NLM) July 03, 2008