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| Tracking Information | |||||||||
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| First Received Date ICMJE | August 10, 2007 | ||||||||
| Last Updated Date | May 26, 2009 | ||||||||
| Start Date ICMJE | May 2006 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Identification of variants/haplotypes in EH-associated genes and characterization of frequencies of variants in priority candidate genes for EH [ Time Frame: Throughout Study ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Change History | Complete list of historical versions of study NCT00515047 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Identifying Genetic Determinants of Eczema Herpeticum and Other Viral Infections in Individuals With Atopic Dermatitis | ||||||||
| Official Title ICMJE | Genetics of Atopic Dermatitis - Eczema Herpeticum | ||||||||
| 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. |
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| 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). 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Other, Cross-Sectional | ||||||||
| Condition ICMJE | Atopic Dermatitis | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 1000 | ||||||||
| Estimated Completion Date | January 2010 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 8 Months to 80 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00515047 | ||||||||
| Responsible Party | Associate Director, Clinical Research Program, DAIT/NIAID | ||||||||
| Study ID Numbers ICMJE | DAIT ADVN GENE 04, HHSN266200400033 | ||||||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Verification Date | May 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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