ADRN Barrier/Immunoprofiling Exploratory Pilot Study

Completed

Conditions studied: Dermatitis, Dermatitis, Atopic, Eczema, Non-atopic Healthy Controls

In brief

The purpose of this study is to look at how defects in the skin barrier and immune response affect risk for skin infections. Participants will be classified into 4 groups based on Atopic Dermatitis (AD)/Non-Atopic (NA) status and Staphylococcus aureus (S. aureus) colonization (negative or positive): * AD S. aureus negative * AD S. aureus positive * NA S. aureus negative and * NA S. aureus positive.

Key facts

Study ID: NCT02115399
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 150
Starts: 2014-04-01
Expected to finish: 2015-06-01
Last updated by the study team: 2015-07-27

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Participants fulfilling all of the following criteria are eligible for enrollment-
Non-Hispanic Caucasian males and females 18 to 60 years of age, inclusive, at the time of Enrollment
Who are enrolled in the ADRN Registry study
Who have active AD (lesions present) with or without a history of Eczema Herpeticum (EH) as defined in the ADRN Standard Diagnostic Criteria OR who meet criteria for the NA diagnostic group as defined in the ADRN Standard Diagnostic Criteria
Who are willing to sign the informed consent form prior to initiation of any study procedures.

You may not qualify if…

Participants fulfilling any of the following criteria are not eligible for enrollment-
Who are pregnant
Who have an active systemic malignancy. Uncomplicated non-melanoma skin cancer and melanoma in situ with documentation of complete excision are not exclusionary
Who have any skin disease other than AD that might compromise the SC barrier (e.g., bullous disease, psoriasis, cutaneous T cell lymphoma [also called Mycosis Fungoides or Sezary syndrome], dermatitis herpetiformis, Hailey-Hailey, or Darier's disease)
Who have a history of systemic immunological illness (e.g., human immunodeficiency virus [HIV] or systemic lupus erythematosus [SLE]) other than the condition being studied
Who have active EH or eczema vaccinatum (EV)
Who have a history of serious or life-threatening reaction to latex, tape, or adhesives
Who are determined to be not eligible based on the opinion of the Investigator.

Where it is running

National Jewish Health — Denver, Colorado, United States
University of Rochester — Rochester, New York, United States
Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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