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| Name | Class |
|---|---|
| Atopic Dermatitis Research Network | OTHER |
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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):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADStaph- | Atopic Dermatitis without a history of Eczema Herpeticum and without S. aureus skin colonization. A minimum of 45 participants will be enrolled in this group. | ||
| ADStaph+ | Atopic Dermatitis without a history of Eczema Herpeticum and with S. aureus skin colonization. A minimum of 45 participants will be enrolled in this group. | ||
| NAStaph- | Non-atopic healthy participants without S. aureus skin colonization. A minimum of 45 participants will be enrolled in this group | ||
| NAStaph+ | Non-atopic healthy participants with S. aureus skin colonization. As the NAStaph+ phenotype is expected to be rare, as many participants as possible will be enrolled in this group; however, we do not expect to enroll 45 participants in this group. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Basal transepidermal water loss (TEWL) | TEWL will be assessed using the AquaFlux AF200 (Biox, London UK) | 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. |
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Inclusion Criteria:
Participants fulfilling all of the following criteria are eligible for enrollment-
Exclusion Criteria:
Participants fulfilling any of the following criteria are not eligible for enrollment-
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Participants enrolled in the ADRN Registry study (NCT01494142) who fulfill eligibility criteria for this (ADRN04) study
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Beck, MD | University of Rochester | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States | ||
| University of Rochester |
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| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
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| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
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Whole blood, skin tissue
| 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. | 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) | 6 month |
| Stratum Corneum (SC) hydration (capacitance) | Stratum Corneum(SC) hydration will be assessed on lesional and non-lesional skin using the Corneometer® CM825 | 6 month |
| Surface pH | Surface pH will be assessed on lesional and non-lesional skin using the Skin-pH Meter® PH 905 | 6 month |
| Stratum Corneum (SC) cohesion assessed as total protein removed per D-Squame tape | 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. | 6 month |
| Peripheral blood mononuclear cells (PBMC) expression of cell surface and intracellular markers | 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. | 6 month |
| Itch assessment | Standardized questionnaires will be used to collect information regarding contact itch intensity | 6 month |
| Quality of Life (QoL) measurement | Standardized questionnaires will be used to collect information regarding Quality of Life | 6 month |
| Transepithelial Electrical Resistance (TEER) assessment from skin biopsies | 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 | 6 month |
| Permeability assessment from skin biopsies | 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. | 6 month |
| Confocal staining of Tight Junction (TJs) from skin biopsies | 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. | 6 month |
| Atopic Dermatitis (AD) severity assessments | AD severity assessments include the Eczema Area and Severity Index (EASI), Rajka-Langeland (R-L) score, and Investigator Global Assessment (IGA) | 6 month |
| Analysis of S. aureus isolates for antibiotic sensitivity | Antibiotic resistance is characterized by methicillin sensitive Staphylococcus aureus (MSSA) vs. methicillin resistant Staphylococcus aureus (MRSA) | 6 month |
| Analysis of S. aureus isolates for expression of virulence or other factors | 6 month |
| Rochester |
| New York |
| 14642 |
| United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |