Status:
COMPLETED
Identifying Risk Factors for Eczema Herpeticum in Individuals With Atopic Dermatitis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Atopic Dermatitis and Vaccinia Network
Conditions:
Atopic Dermatitis
Eczema Herpeticum
Eligibility:
All Genders
18-60 years
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...
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 ho...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Participants with AD:
- Diagnosis of AD as defined by ADVN standardized diagnostic criteria who fall into one of the following categories:
- Recurrent, clinically manifested HSV infection with EH
- Recurrent, clinically manifested HSV infection without EH
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00438022
Start Date
March 1 2006
End Date
January 1 2010
Last Update
October 6 2016
Active Locations (1)
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1
University of Bonn, Germany
Bonn, Germany