ADRN Barrier/Immunoprofiling Exploratory Pilot Study

National Institute of Allergy and Infectious Diseases (NIAID)150 enrolled

Overview

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.

Atopic dermatitis, also called eczema, is a disease in which the skin is dry and scaly with severe itching. People with atopic dermatitis have defects in the skin barrier as well as defects in the immune system which fights off skin infections. People who have atopic dermatitis often have complications from viral and bacterial skin infections, such as recurring Staphylococcus aureus (S. aureus), or Staph infections. The study will compare the skin barrier and immune response of people with and without atopic dermatitis in relation to whether Staph bacteria is growing on their skin.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Dermatitis Dermatitis, Atopic Eczema Non-atopic Healthy Controls

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 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. Exclusion Criteria: 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.

Locations (3)

National Jewish Health

Denver, Colorado, United States

University of Rochester

Rochester, New York, United States

Oregon Health & Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

The area under the transepidermal water loss (TEWL) curve

TEWL will be assessed using the AquaFlux AF200 (Biox, London UK) Transepidermal water loss (TEWL) will be assessed on non-lesional skin prior to tape stripping and repeated after 5, 10, 15, and 20 tape strips

Time frame: 6 month

Secondary Outcomes

Basal transepidermal water loss (TEWL)

TEWL will be assessed using the AquaFlux AF200 (Biox, London UK)

Time frame: 6 month

Transepidermal water loss (TEWL) measured after 20 tape strips

Transepidermal water loss (TEWL) will be assessed using the AquaFlux AF200 (Biox, London UK). TEWL assessments will be done on non-lesional skin prior to tape stripping and after 20 tape strips and on unstripped lesional skin.

Time frame: 6 month

Change in transepidermal water loss (TEWL)

Transepidermal water loss (TEWL) will be assessed using the AquaFlux AF200 (Biox, London UK). TEWL after 20 tape strips minus transepidermal water loss (TEWL) prior to tape stripping.

Time frame: 6 month

Change in transepidermal water loss (TEWL) per every 5 tape strips (i.e. slope)

TEWL will be assessed using the AquaFlux AF200 (Biox, London UK)

Time frame: 6 month

Stratum Corneum (SC) hydration (capacitance)

Stratum Corneum(SC) hydration will be assessed on lesional and non-lesional skin using the Corneometer® CM825

Time frame: 6 month

Surface pH

Surface pH will be assessed on lesional and non-lesional skin using the Skin-pH Meter® PH 905

Data from ClinicalTrials.gov

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