Identifying Risk Factors for Eczema Herpeticum in Individuals With Atopic Dermatitis
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 20, 2007 | ||||
| Last Updated Date | March 14, 2013 | ||||
| Start Date ICMJE | March 2006 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Immunohistochemistry will be used to confirm the expression of IgE receptors and IgE binding of myeloid and plasmacytoid Dendritic Cells. [ Time Frame: 3 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00438022 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Identifying Risk Factors for Eczema Herpeticum in Individuals With Atopic Dermatitis | ||||
| Official Title ICMJE | Risk Factors in Atopic Dermatitis for the Development of Eczema Herpeticum | ||||
| Brief Summary | 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. |
||||
| Detailed Description | 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. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Blood and skin samples will be retained |
||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | People of good general health, living in Germany |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 240 | ||||
| Completion Date | January 2010 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria for Participants with AD:
Inclusion Criteria for All Participants
Exclusion Criteria for All Participants:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00438022 | ||||
| Other Study ID Numbers ICMJE | DAIT ADVN ADEH 06, Contract No. HHSN266200400029C | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
| Verification Date | March 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||