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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00438022 |
Purpose
Atopic Dermatitis (AD), also known as eczema, is a skin disease that causes the skin to be hot, dry and scaly, and have severe itching. There are different kinds of eczema. Eczema herpeticum (EH) is a type of eczema that spreads due to an underlying herpes virus infection. The purpose of this research study is to identify the risk factors that may cause EH.
| Condition |
|---|
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Atopic Dermatitis Eczema Herpeticum |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | Risk Factors in Atopic Dermatitis for the Development of Eczema Herpeticum |
Blood and skin samples will be retained
| Estimated Enrollment: | 240 |
| Study Start Date: | March 2006 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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1
Group 1 will include participants with AD and recurrent herpes simplex virus (HSV)
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2
Group 2 will include participants with recurring HSV infections but without EH
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3
Group 3 will include participants with AD but without EH or HSV infection
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4
Group 4 will include participants in good general health without AD, EH, or HSV infection
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AD is characterized by chronic skin inflammation and infections. It is hypothesized that AD is caused by irritants in the environment and that symptoms of EH become worse with stress and changes in hormone levels. This study will examine skin cells collected from study participants to determine the risk factors for EH that are present in people with AD who develop EH.
This study will examine dendritic cells (DC) from the skin and blood of study participants to determine the differences between DCs of study participants. This study will recruit four types of participants:
At the single study visit, skin and blood collection will occur.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
People of good general health, living in Germany
Inclusion Criteria for Participants with AD:
Diagnosis of AD as defined by ADVN standardized diagnostic criteria who fall into one of the following categories:
Inclusion Criteria for All Participants
Exclusion Criteria for All Participants:
Contacts and Locations| Contact: Thomas Bieber, MD, PhD | +49-228-287-1-4388 | Thomas.Bieber@ukb.uni-bonn.de |
| Contact: Natalija Novak, MD | +49-228-287-1-5370 | Natalija.Novak@ukb.uni-bonn.de |
| Germany | |
| University of Bonn, Germany | Recruiting |
| Bonn, Germany | |
| Contact: Thomas Bieber, MD, PhD +49-228-287-1-4388 Thomas.Bieber@ukb.uni-bonn.de | |
| Contact: Natalija Novak, MD, PhD +49-228-287-1-5370 Natalija.Noval@ukb.uni-bonn.de | |
| Principal Investigator: Thomas Bieber, MD, PhD | |
| Sub-Investigator: Natalija Novak, MD | |
| Principal Investigator: | Thomas Bieber, MD, PhD | University of Bonn, Germany |
More Information
| Responsible Party: | DAIT/NIAID ( Associate Director, Clinical Research Program ) |
| Study ID Numbers: | DAIT ADVN ADEH 06, Contract No. HHSN266200400029C |
| Study First Received: | February 20, 2007 |
| Last Updated: | July 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00438022 History of Changes |
| Health Authority: | United States: Federal Government |
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Atopic Dermatitis Eczema Herpeticum |
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Herpes Simplex Dermatitis, Atopic Skin Diseases Immune System Diseases Eczema 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 |