Clinical trial NCT02115399: ADRN Barrier/Immunoprofiling Exploratory Pilot Study
Official title: ADRN Barrier/Immunoprofiling Exploratory Pilot Study (ADRN-04)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermatitis
Dermatitis, Atopic
Eczema
Non-atopic Healthy Controls
Keywords: Dermatitis
Staphylococcus
Staphylococcus aureus
Dermatitis, Atopic
Non-atopic controls
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Atopic Dermatitis Research Network
First posted: 2014-04-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants enrolled in the ADRN Registry study (NCT01494142) who fulfill eligibility criteria for this (ADRN04) study

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The area under the transepidermal water loss (TEWL) curve
timeFrame: 6 month
Secondary outcomes:
measure: Basal transepidermal water loss (TEWL)
timeFrame: 6 month
measure: Transepidermal water loss (TEWL) measured after 20 tape strips
timeFrame: 6 month
measure: Change in transepidermal water loss (TEWL)
timeFrame: 6 month
measure: Change in transepidermal water loss (TEWL) per every 5 tape strips (i.e. slope)
timeFrame: 6 month
measure: Stratum Corneum (SC) hydration (capacitance)
timeFrame: 6 month
measure: Surface pH
timeFrame: 6 month
measure: Stratum Corneum (SC) cohesion assessed as total protein removed per D-Squame tape
timeFrame: 6 month
measure: Peripheral blood mononuclear cells (PBMC) expression of cell surface and intracellular markers
timeFrame: 6 month
measure: Itch assessment
timeFrame: 6 month
measure: Quality of Life (QoL) measurement
timeFrame: 6 month
measure: Transepithelial Electrical Resistance (TEER) assessment from skin biopsies
timeFrame: 6 month
measure: Permeability assessment from skin biopsies
timeFrame: 6 month
measure: Confocal staining of Tight Junction (TJs) from skin biopsies
timeFrame: 6 month
measure: Atopic Dermatitis (AD) severity assessments
timeFrame: 6 month
measure: Analysis of S. aureus isolates for antibiotic sensitivity
timeFrame: 6 month
measure: Analysis of S. aureus isolates for expression of virulence or other factors
timeFrame: 6 month
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: University of Rochester
name: Lisa Beck, MD
role: STUDY_CHAIR
References: