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Identifying Risk Factors for Eczema Herpeticum in Individuals With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00438022
Recruitment Status : Completed
First Posted : February 21, 2007
Last Update Posted : October 6, 2016
Sponsor:
Collaborator:
Atopic Dermatitis and Vaccinia Network
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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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.

Condition or disease
Atopic Dermatitis Eczema Herpeticum

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.

Study Design
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Study Type : Observational
Actual Enrollment : 240 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Risk Factors in Atopic Dermatitis for the Development of Eczema Herpeticum
Study Start Date : March 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. Immunohistochemistry will be used to confirm the expression of IgE receptors and IgE binding of myeloid and plasmacytoid Dendritic Cells. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]

Biospecimen Retention:   Samples With DNA
Blood and skin samples will be retained

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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., alefacept, 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438022


Locations
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Germany
University of Bonn, Germany
Bonn, Germany
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Atopic Dermatitis and Vaccinia Network
Investigators
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Principal Investigator: Thomas Bieber, MD, PhD University of Bonn
More Information
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Additional Information:

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: Study ID is SDY4
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: Study ID is SDY4
Study details, -download packages, et al.  This link exits the ClinicalTrials.gov site
Identifier: Study ID is SDY4

Publications of Results:

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00438022    
Other Study ID Numbers: DAIT ADVN ADEH 06
HHSN266200400029C ( Other Identifier: NIH Contract )
First Posted: February 21, 2007    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participant level data access is available to the public in the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Atopic Dermatitis
Eczema Herpeticum
Additional relevant MeSH terms:
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Kaposi Varicelliform Eruption
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious