NCT00515047

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2006

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 2, 2014

Status Verified

April 1, 2014

Enrollment Period

4.7 years

First QC Date

August 10, 2007

Last Update Submit

April 1, 2014

Conditions

Keywords

Atopic DermatitisEczemaEczema HerpeticumMolluscum ContagiousumHerpes SimplexVaccinia

Outcome Measures

Primary Outcomes (1)

  • Identification of variants/haplotypes in EH-associated genes and characterization of frequencies of variants in priority candidate genes for EH

    Throughout Study

Secondary Outcomes (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

Study Arms (3)

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

Eligibility Criteria

Age8 Months - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of California at San Diego

La Jolla, California, 92037, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Children's Memorial Hospital

Chicago, Illinois, United States

Location

Northwestern University

Chicago, Illinois, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Oregon Health & Sciences University

Portland, Oregon, 97239, United States

Location

Related Publications (6)

  • Baker BS. The role of microorganisms in atopic dermatitis. Clin Exp Immunol. 2006 Apr;144(1):1-9. doi: 10.1111/j.1365-2249.2005.02980.x.

    PMID: 16542358BACKGROUND
  • 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. doi: 10.1016/j.jaci.2006.10.005. Epub 2006 Dec 4.

    PMID: 17141855BACKGROUND
  • 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. doi: 10.1017/s0950268800068072.

    PMID: 2824227BACKGROUND
  • 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. doi: 10.1002/(SICI)1096-9071(199608)49:43.0.CO;2-5.

    PMID: 8877767BACKGROUND
  • Gao PS, Leung DY, Rafaels NM, Boguniewicz M, Hand T, Gao L, Hata TR, Schneider LC, Hanifin JM, Beaty TH, Beck LA, Weinberg A, Barnes KC. Genetic variants in interferon regulatory factor 2 (IRF2) are associated with atopic dermatitis and eczema herpeticum. J Invest Dermatol. 2012 Mar;132(3 Pt 1):650-7. doi: 10.1038/jid.2011.374. Epub 2011 Nov 24.

  • Gao PS, Rafaels NM, Mu D, Hand T, Murray T, Boguniewicz M, Hata T, Schneider L, Hanifin JM, Gallo RL, Gao L, Beaty TH, Beck LA, Leung DY, Barnes KC. Genetic variants in thymic stromal lymphopoietin are associated with atopic dermatitis and eczema herpeticum. J Allergy Clin Immunol. 2010 Jun;125(6):1403-1407.e4. doi: 10.1016/j.jaci.2010.03.016. Epub 2010 May 13. No abstract available.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Skin scrapings and blood collection may occur

MeSH Terms

Conditions

Dermatitis, AtopicEczemaKaposi Varicelliform EruptionHerpes SimplexVaccinia

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousPoxviridae Infections

Study Officials

  • Lisa Beck, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR
  • Kathleen Barnes, PhD

    Johns Hopkins Allergy and Asthma Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2007

First Posted

August 13, 2007

Study Start

May 1, 2006

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

April 2, 2014

Record last verified: 2014-04

Locations