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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00515047 |
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 |
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Atopic Dermatitis |
Study Type: | Observational |
Study Design: | Cross-Sectional |
Official Title: | Genetics of Atopic Dermatitis - Eczema Herpeticum |
Skin scrapings and blood collection may occur
Estimated Enrollment: | 1000 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | January 2010 |
Groups/Cohorts |
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1
People with AD will provide samples that will be exposed to HSV-1 to stimulate gene expression
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2
People with AD will provide samples that will be exposed vaccinia to stimulate gene expression
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3
People with AD will provide samples that will be exposed molluscum contagiosum to stimulate gene expression
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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.
Ages Eligible for Study: | 8 Months to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
African-American, Caucasian, and Non-Hispanic people ages 8 months to 80 years
Inclusion Criteria:
Exclusion Criteria:
Contact: Judy Lairsmith | (303) 270-2413 | lairsmithj@NJHealth.org |
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 |
Principal Investigator: | Lisa Beck, MD | University of Rochester |
Principal Investigator: | Kathleen Barnes, PhD | Johns Hopkins Allergy and Asthma Center |
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 |
Atopic Dermatitis Eczema Eczema Herpeticum |
Molluscum Contagiousum Herpes Simplex Vaccinia |
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 |
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 |