Identifying Risk Factors for Eczema Herpeticum in Individuals With Atopic Dermatitis

October 4, 2016 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany
        • University of Bonn, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People of good general health, living in Germany

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 years
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 years
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
3 years
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
3 years
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Atopic Dermatitis and Vaccinia Network

Investigators

  • Principal Investigator: Thomas Bieber, MD, PhD, University of Bonn

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

February 20, 2007

First Submitted That Met QC Criteria

February 20, 2007

First Posted (Estimate)

February 21, 2007

Study Record Updates

Last Update Posted (Estimate)

October 6, 2016

Last Update Submitted That Met QC Criteria

October 4, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAIT ADVN ADEH 06
  • HHSN266200400029C (Other Identifier: NIH Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: Study ID is SDY4
  2. Study Protocol
    Information identifier: Study ID is SDY4
  3. Study details, -download packages, et al.
    Information identifier: Study ID is SDY4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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