Identifying Risk Factors for Eczema Herpeticum in Individuals With Atopic Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00438022
First received: February 20, 2007
Last updated: March 14, 2013
Last verified: March 2013

February 20, 2007
March 14, 2013
March 2006
January 2010   (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 Dendritic Cells. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Not Provided
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 ]
  • Expression of HSV-receptors cluster of differentiation, costimulatory molecules, major histocompatibility complex, Toll-like receptor (TLR), and structures involved in antigen presentation of myeloid and plasmacytoid DCs. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Evaluate the capacity of T-cells, stimulated and unstimulated myeloid DCs or plasmacytoid DCs to produce the T-helper cell 2 (Th2) cytokines IL-4, IL-5 and IL-13 and the T-helper cell 1 (Th1) cytokines IL-2 and IFN-γ and IL-10/TGF-β. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • The phenotype of T-cells cocultured with HSV/CpG stimulated and unstimulated myeloid DCs or plasmacytoid DCs will be evaluated by flow cytometry. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • The proliferation of T-cells cocultured with HSV/CpG stimulated and unstimulated myeloid DCs or plasmacytoid DCs will be measured with the help of flow cytometry by proliferating cell nuclear antigen. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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, EH, and recurrent herpes simplex virus (HSV)
  • Group 2 will include participants with AD and 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
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood and skin samples will be retained

Non-Probability Sample

People of good general health, living in Germany

  • Atopic Dermatitis
  • Eczema Herpeticum
Not Provided
  • 1
    Group 1 will include participants with AD, EH, and recurrent herpes simplex virus (HSV)
  • 2
    Group 2 will include participants with AD and recurring HSV infections but without EH
  • 3
    Group 3 will include participants with AD but without EH or HSV infection
  • 4
    Group 4 will include participants in good general health without AD, EH, or HSV infection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
January 2010
January 2010   (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
  • Individuals between 18-60 years of age

Exclusion Criteria for All Participants:

  • Subjects with atopy but lacking stringent AD features, allowing only a presumptive diagnosis of AD
  • Individuals under 18 or over 60 years of age
  • 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
  • Inability or unwillingness of a subject to give written informed consent
  • Weigh less than 40 kg (88.2 lb)
  • Anxiolytic agents
  • Antidepressants
  • Pregnancy or breastfeeding
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00438022
DAIT ADVN ADEH 06, Contract No. HHSN266200400029C
Yes
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Thomas Bieber, MD, PhD University of Bonn, Germany
National Institute of Allergy and Infectious Diseases (NIAID)
March 2013

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