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Completed

NCT Number: NCT02115399

ADRN Barrier/Immunoprofiling Exploratory Pilot Study

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.

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Key information

Conditions

Dermatitis Bacterial Infections Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis, Atopic Eczema Genetic Diseases, Inborn Gram-Positive Bacterial Infections Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Non-atopic Healthy Controls Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases Staphylococcal Infections

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Jewish Health, Denver, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The area under the transepidermal water loss (TEWL) curve

    Time frame: 6 month

    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

Secondary outcomes

  1. Basal transepidermal water loss (TEWL)

    Time frame: 6 month

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

  2. Transepidermal water loss (TEWL) measured after 20 tape strips

    Time frame: 6 month

    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.

  3. Change in transepidermal water loss (TEWL)

    Time frame: 6 month

    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.

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

    Time frame: 6 month

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

  5. Stratum Corneum (SC) hydration (capacitance)

    Time frame: 6 month

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

  6. Surface pH

    Time frame: 6 month

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

  7. Stratum Corneum (SC) cohesion assessed as total protein removed per D-Squame tape

    Time frame: 6 month

    The assessment of SC cohesion will be conducted by two different methods. First, serial measurements of transepidermal water loss (TEWL) will be performed after tape stripping. Second, the amount of protein removed per strip will be calculated by an optical absorbance technique using a CuDerm SquameScan 850A.

  8. Peripheral blood mononuclear cells (PBMC) expression of cell surface and intracellular markers

    Time frame: 6 month

    Measured after ex vivo stimulation with a polyclonal T cell stimulus, toll-like receptor ligands (TLRs), iron-regulated surface determinant B (IsdB) as an immunodominant S. aureus antigen, and recall antigens, such as influenza and tetanus antigens, and media alone as the control.

  9. Itch assessment

    Time frame: 6 month

    Standardized questionnaires will be used to collect information regarding contact itch intensity

  10. Quality of Life (QoL) measurement

    Time frame: 6 month

    Standardized questionnaires will be used to collect information regarding Quality of Life

  11. Transepithelial Electrical Resistance (TEER) assessment from skin biopsies

    Time frame: 6 month

    Two punch biopsies of non-lesional skin will be obtained. One biopsy will be used for assessments of Tight Junction (TJ) function including confocal imaging, Transepithelial Electrical Resistance (TEER), and permeability measurements

  12. Permeability assessment from skin biopsies

    Time frame: 6 month

    Two punch biopsies of non-lesional skin will be obtained. One biopsy will be used for assessments of Tight Junction (TJ) function including confocal imaging, Transepithelial Electrical Resistance (TEER), and permeability measurements.

  13. Confocal staining of Tight Junction (TJs) from skin biopsies

    Time frame: 6 month

    Two punch biopsies of non-lesional skin will be obtained. One biopsy will be used for confocal staining of Tight Junction (TJs) and routine histology.

  14. Atopic Dermatitis (AD) severity assessments

    Time frame: 6 month

    AD severity assessments include the Eczema Area and Severity Index (EASI), Rajka-Langeland (R-L) score, and Investigator Global Assessment (IGA)

  15. Analysis of S. aureus isolates for antibiotic sensitivity

    Time frame: 6 month

    Antibiotic resistance is characterized by methicillin sensitive Staphylococcus aureus (MSSA) vs. methicillin resistant Staphylococcus aureus (MRSA)

  16. Analysis of S. aureus isolates for expression of virulence or other factors

    Time frame: 6 month

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • Atopic Dermatitis Research Network

Registry information

Official study title

ADRN Barrier/Immunoprofiling Exploratory Pilot Study (ADRN-04)

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 16, 2014
Registry last updated
Jul 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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