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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.
U.S. FDA Resources
| Study Type: |
Observational |
| Study Design: |
Other, Cross-Sectional |
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| Official Title: |
Genetics of Atopic Dermatitis - Eczema Herpeticum |
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 |
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.
| Ages Eligible for Study: |
1 Year to 80 Years |
| Genders Eligible for Study: |
Both |
| Accepts Healthy Volunteers: |
Yes |
| Sampling Method: |
Non-Probability Sample |
African-American, Caucasion, and Non-Hispanic people ages 1 to 80
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 ).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515047
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| University of California at San Diego |
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| La Jolla, California, United States, 92037 |
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| Contact: Michelle Jackson, MD 858-657-7192 m5jackson@ucsd.edu |
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| Principal Investigator: Richard Gallo, MD, PhD |
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| Sub-Investigator: Tissa Hata, MD |
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| National Jewish Medical & Research Center |
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| Denver, Colorado, United States, 80206 |
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| Contact: Judy Lairsmith 303-270-2413 lairsmithj@njc.org |
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| Principal Investigator: Donald Leung, MD, PhD |
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| Sub-Investigator: Mark Boguniewicz, MD |
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| Children's Hospital Boston |
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| Boston, Massachusetts, United States, 02115 |
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| Contact: Lisa Heughan 617-355-6127 lisa.heughan@childrens.harvard.edu |
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| Principal Investigator: Lynda Schneider, MD |
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| University of Rochester Medical Center |
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| Rochester, New York, United States, 14642 |
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| Contact: Lorianne Stubbs 585-275-0374 Lorianne_Stubbs@urmc.rochester.edu |
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| Principal Investigator: Lisa Beck, MD |
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| Oregon Health & Sciences University |
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| Portland, Oregon, United States, 97239 |
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| Contact: Susan Tofte 503-494-6445 toftes@ohsu.edu |
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| Principal Investigator: Jon Hanifin, MD, PhD |
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| Sub-Investigator: Mark Slifka, PhD |
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| Sub-Investigator: Eric Simpson, MD |
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| Principal Investigator: |
Lisa Beck, MD |
University of Rochester |
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| University of California at San Diego |
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| La Jolla, California, United States, 92037 |
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| Contact: Michelle Jackson, MD 858-657-7192 m5jackson@ucsd.edu |
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| Principal Investigator: Richard Gallo, MD, PhD |
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| Sub-Investigator: Tissa Hata, MD |
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| National Jewish Medical & Research Center |
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| Denver, Colorado, United States, 80206 |
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| Contact: Judy Lairsmith 303-270-2413 lairsmithj@njc.org |
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| Principal Investigator: Donald Leung, MD, PhD |
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| Sub-Investigator: Mark Boguniewicz, MD |
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| Children's Hospital Boston |
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| Boston, Massachusetts, United States, 02115 |
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| Contact: Lisa Heughan 617-355-6127 lisa.heughan@childrens.harvard.edu |
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| Principal Investigator: Lynda Schneider, MD |
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| University of Rochester Medical Center |
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| Rochester, New York, United States, 14642 |
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| Contact: Lorianne Stubbs 585-275-0374 Lorianne_Stubbs@urmc.rochester.edu |
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| Principal Investigator: Lisa Beck, MD |
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| Oregon Health & Sciences University |
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| Portland, Oregon, United States, 97239 |
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| Contact: Susan Tofte 503-494-6445 toftes@ohsu.edu |
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| Principal Investigator: Jon Hanifin, MD, PhD |
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| Sub-Investigator: Mark Slifka, PhD |
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| Sub-Investigator: Eric Simpson, MD |
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| Principal Investigator: |
Lisa Beck, MD |
University of Rochester |
Publications:
Baker BS. The role of microorganisms in atopic dermatitis. Clin Exp Immunol. 2006 Apr;144(1):1-9. Review. |
Kim BE, Leung DY, Streib JE, 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. Epub 2006 Dec 4. |
Porter CD, Muhlemann MF, Cream JJ, Archard LC. Molluscum contagiosum: characterization of viral DNA and clinical features. Epidemiol Infect. 1987 Oct;99(2):563-7. |
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. |
| 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 | |
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| Molluscum Contagiousum |
| Herpes Simplex |
| Vaccinia | |
Study placed in the following topic categories:
| Herpes Simplex |
| Dermatitis, Atopic |
| Vaccinia |
| Eczema |
| Herpesviridae Infections |
| Kaposi Varicelliform Eruption |
| Exanthema | |
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| 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 | |
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| Genetic Diseases, Inborn |
| Skin Diseases |
| Dermatitis, Atopic | | Source: National Library of Medicine (NLM) July 03, 2008
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