Identifying Genetic Determinants of Eczema Herpeticum and Other Viral Infections in Individuals With Atopic Dermatitis (Genetics)
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| ClinicalTrials.gov Identifier: NCT00515047 |
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Recruitment Status :
Completed
First Posted : August 13, 2007
Last Update Posted : April 2, 2014
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| Condition or disease |
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| Atopic Dermatitis |
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.
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 have high-throughput genotyping to define genetic markers in individuals susceptible to viral infections.
| Study Type : | Observational |
| Actual Enrollment : | 900 participants |
| Time Perspective: | Cross-Sectional |
| Official Title: | Genetics of Atopic Dermatitis - Eczema Herpeticum |
| Study Start Date : | May 2006 |
| Actual Primary Completion Date : | January 2011 |
| Actual Study Completion Date : | January 2011 |
| Group/Cohort |
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Eczema Herpeticum (EH)
Participants with AD who currently have or have had EH
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Non-EH
Participants with AD who do not have and have never had EH
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Healthy Controls
Healthy participants without a history of AD
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- Identification of variants/haplotypes in EH-associated genes and characterization of frequencies of variants in priority candidate genes for EH [ Time Frame: Throughout Study ]
- 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 ]
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 8 Months to 80 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00515047
| United States, California | |
| University of California at San Diego | |
| La Jolla, California, United States, 92037 | |
| United States, Colorado | |
| National Jewish Health | |
| Denver, Colorado, United States, 80206 | |
| United States, Illinois | |
| Children's Memorial Hospital | |
| Chicago, Illinois, United States | |
| Northwestern University | |
| Chicago, Illinois, United States | |
| United States, Massachusetts | |
| Children's Hospital Boston | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, Oregon | |
| Oregon Health & Sciences University | |
| Portland, Oregon, United States, 97239 | |
| Principal Investigator: | Lisa Beck, MD | University of Rochester | |
| Principal Investigator: | Kathleen Barnes, PhD | Johns Hopkins Allergy and Asthma Center |
Publications of Results:
Other Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00515047 |
| Other Study ID Numbers: |
DAIT ADVN GENE 04 HHSN266200400033 |
| First Posted: | August 13, 2007 Key Record Dates |
| Last Update Posted: | April 2, 2014 |
| Last Verified: | April 2014 |
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Atopic Dermatitis Eczema Eczema Herpeticum |
Molluscum Contagiousum Herpes Simplex Vaccinia |
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Kaposi Varicelliform Eruption Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Herpes Simplex Herpesviridae Infections DNA Virus Infections Virus Diseases Skin Diseases, Viral Skin Diseases, Infectious |