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: April 1, 2014
Last verified: April 2014
  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
Atopic Dermatitis
Eczema Herpeticum

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Risk Factors in Atopic Dermatitis for the Development of Eczema Herpeticum

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Blood and skin samples will be retained


Enrollment: 240
Study Start Date: March 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

People of good general health, living in Germany

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438022

Locations
Germany
University of Bonn, Germany
Bonn, Germany
Sponsors and Collaborators
Investigators
Principal Investigator: Thomas Bieber, MD, PhD University of Bonn
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00438022     History of Changes
Other Study ID Numbers: DAIT ADVN ADEH 06, Contract No. HHSN266200400029C
Study First Received: February 20, 2007
Last Updated: April 1, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Atopic Dermatitis
Eczema Herpeticum

Additional relevant MeSH terms:
Eczema
Dermatitis
Dermatitis, Atopic
Kaposi Varicelliform Eruption
DNA Virus Infections
Genetic Diseases, Inborn
Herpes Simplex
Herpesviridae Infections
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Skin Diseases, Infectious
Skin Diseases, Viral
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014