ADRN Barrier/Immunoprofiling Exploratory Pilot Study

Dermatitis, Atopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02115399
• Other study ID #: DAIT ADRN-04
• Status: Completed
• Phase: N/A
• First received: April 14, 2014
• Last updated: July 23, 2015
• Start date: April 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Non-atopic Healthy Controls

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado
United States	Oregon Health & Science University	Portland	Oregon
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Atopic Dermatitis Research Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Basal transepidermal water loss (TEWL)	TEWL will be assessed using the AquaFlux AF200 (Biox, London UK)	6 month	No
Secondary	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.	6 month	No
Secondary	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	No
Secondary	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	No
Secondary	Stratum Corneum (SC) hydration (capacitance)	Stratum Corneum(SC) hydration will be assessed on lesional and non-lesional skin using the Corneometer® CM825	6 month	No
Secondary	Surface pH	Surface pH will be assessed on lesional and non-lesional skin using the Skin-pH Meter® PH 905	6 month	No
Secondary	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	No
Secondary	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	No
Secondary	Itch assessment	Standardized questionnaires will be used to collect information regarding contact itch intensity	6 month	No
Secondary	Quality of Life (QoL) measurement	Standardized questionnaires will be used to collect information regarding Quality of Life	6 month	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	Analysis of S. aureus isolates for expression of virulence or other factors		6 month	No

External Links

•   National Institute of Allergy and Infectious Diseases (NIAID)