ADRN Barrier/Immunoprofiling Exploratory Pilot Study

NCT02115399 | Completed

• 1 other identifier: DAIT ADRN-04
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Dermatitis; Staphylococcus; Staphylococcus aureus; Dermatitis, Atopic; Non-atopic controls

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (16)

• Basal transepidermal water loss (TEWL)

  6 month

• Transepidermal water loss (TEWL) measured after 20 tape strips

  6 month

• Change in transepidermal water loss (TEWL)

  6 month

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

  6 month

• Stratum Corneum (SC) hydration (capacitance)

  6 month

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants enrolled in the ADRN Registry study (NCT01494142) who fulfill eligibility criteria for this (ADRN04) study

You may qualify if:

• 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.

You may not qualify if:

• Participants fulfilling any of the following criteria are not eligible for enrollment-
• Who are pregnant
• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Atopic Dermatitis Research Network: collaborator

Study Sites (3)

National Jewish Health

Denver, Colorado, 80206, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID)

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, skin tissue

MeSH Terms

Conditions

Dermatitis; Dermatitis, Atopic; Eczema; Staphylococcal Infections

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Lisa Beck, MD

  University of Rochester

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 16, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 27, 2015

Record last verified: 2015-07

Locations

US (3)