Full Text View
Tabular View
No Study Results Posted
Related Studies
Identifying Risk Factors for Eczema Herpeticum in Individuals With Atopic Dermatitis
This study is currently recruiting participants.
Study NCT00438022   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)
First Received: February 20, 2007   Last Updated: July 28, 2009   History of Changes

February 20, 2007
July 28, 2009
March 2006
December 2009   (final data collection date for primary outcome measure)
Immunohistochemistry will be used to confirm the expression of IgE receptors and IgE binding of myeloid and plasmacytoid Dendrytic Cells. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00438022 on ClinicalTrials.gov Archive Site
The capacity of myeloid and plasmacytoid DCs to produce IFN-α/IFN-β and of myeloid DCs to produce IL-10, IL-12, and IL-18 will be evaluated. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
 
Identifying Risk Factors for Eczema Herpeticum in Individuals With Atopic Dermatitis
Risk Factors in Atopic Dermatitis for the Development of Eczema Herpeticum

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.

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:

  • Group 1 will include participants with AD and recurrent herpes simplex virus (HSV)
  • Group 2 will include participants with recurring HSV infections but without EH
  • Group 3 will include participants with AD but without EH or HSV infection
  • Group 4 will include participants in good general health without AD, EH, or HSV infection

At the single study visit, skin and blood collection will occur.

 
Observational
Case Control, Prospective
  • Atopic Dermatitis
  • Eczema Herpeticum
 
  • Group 1 will include participants with AD and recurrent herpes simplex virus (HSV)
  • Group 2 will include participants with recurring HSV infections but without EH
  • Group 3 will include participants with AD but without EH or HSV infection
  • Group 4 will include participants in good general health without AD, EH, or HSV infection
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
240
 
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria for Participants with AD:

  • Diagnosis of AD as defined by ADVN standardized diagnostic criteria who fall into one of the following categories:

    1. Recurrent, clinically manifested HSV infection with EH
    2. Recurrent, clinically manifested HSV infection without EH
    3. No recurrent, clinically manifested HSV infection or EH infection

Inclusion Criteria for All Participants

  • Residing in Germany
  • Good general health other than having an atopic disease
  • Caucasian

Exclusion Criteria for All Participants:

  • Systemic immunosuppressive drugs or chemotherapy 30 days prior to study entry
  • Oral and topical corticosteroids (including inhaled agents), antibiotics, antivirals, anti-inflammatory biologics (e.g., alfacept, etanercept), topical doxepin, topical coal tar preparations, or topical phosphodiesterase inhibitors 14 days prior to study entry
  • Immunotherapy
  • Antibiotics, antivirals, immune enhancers (e.g., imiquimod), or calcineurin inhibitors within 7 days prior to study entry
  • Phototherapy (e.g., ultraviolet light B [UVB], psoralen plus ultraviolet light A [PUVA]) 30 days prior to study entry
  • Cancer, autoimmune diseases, or immunodeficiency
  • Active fungal, bacterial, or viral infections at screening
  • Any skin diseases other than AD that might compromise the stratum corneum barrier (e.g., ichthyosis, bullous disease, psoriasis, skin cancer)
  • Mental illness or a history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements
  • Weigh less than 40 kg (88.2 lb)
  • Anxiolytic agents
  • Antidepressants
  • Pregnancy or breastfeeding
Both
18 Years to 60 Years
Yes
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
 
NCT00438022
Associate Director, Clinical Research Program, DAIT/NIAID
DAIT ADVN ADEH 06, Contract No. HHSN266200400029C
National Institute of Allergy and Infectious Diseases (NIAID)
 
Principal Investigator: Thomas Bieber, MD, PhD University of Bonn, Germany
National Institute of Allergy and Infectious Diseases (NIAID)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP