Skin Microbial Ecology in Atopic Dermatitis

Longitudinal "Real-World" Changes in Skin Microbial Ecology in Atopic Dermatitis (AD) and Psoriasis (PS) Patients

Everybody's skin has bacteria that normally lives on it. Previous research has shown that people with eczema (or atopic dermatitis [AD]) have much higher concentrations of a certain bacteria (S. aureus), especially when their disease is active but little is known about the role that this bacteria plays in psoriasis (i.e. disease severity, biomarkers and skin barrier function). The overarching purpose of this longitudinal study is to understand how the abundance of skin S. aureus (and several commensal bacteria) change as a consequence of standard of care treatment in the URMC dermatology clinics. Other assays and biospecimens will also be collected to address a number of questions.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Psoriasis; Atopic Dermatitis
• Intervention / Treatment: Other: AD subject visit sampling procedures; Other: Healthy control visit sampling procedures; Other: PS subject visit sampling procedures

Detailed Description

Although the two most common inflammatory skin diseases (AD and Psoriasis) are now quite effectively managed with topical and/or systemic therapies, how this disease improvement is reflected in changes of skin microbial pathogens and commensals is still not well understood. We have several aims.

Aim 1 - Determine how the abundance of S. aureus, other microbes of interest including, but not exclusive to, coagulase-negative Staphylococcus species [CONS], and C. acnes on the skin surface varies as a function of time and/or disease activity in AD, plaque stage psoriasis (PS) and healthy, non-atopics (NA). Aim 2 - Validate whether a biomarker (or panel) identifies subjects with greater S. aureus burden (e.g., abundance). Aim 3 - Identify a biomarker (or panel) that predicts clinical improvement observed in our AD or PS subjects. Aim 4 - Quantify S. aureus virulence factors from skin swabs of all three subject populations. Exploratory Aim 5 - Develop a skin microbial repository (optional) where we will focus on the interplay between S. aureus and other microbes from AD and PS patients, and age- and gender-matched healthy NAs. Exploratory Aim 6 - Develop a repository of skin tape strips for biomarker and protease assays. Exploratory Aim 7 - (optional enrollment) - To identify skin epithelial gene signatures from AD skin that are unique and not found in healthy non- AD, NA control skin samples after they are infected ex vivo with HSV-1. A secondary goal of this work will be to evaluate how Real-World treatment(s) affect these observations.

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Dermatology clinical trials unit; Phone Number: 585-273-4195; Email: DermCTU_Appointments@URMC.Rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester Medical Center
      • Contact: Lisa Beck, MD; Phone Number: 585-275-7546; Email: lisa_beck@urmc.rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The healthy population will be defined as individuals with no personal history of or active case of any atopic disorder (e.g. atopic dermatitis, allergic rhinitis, asthma, hay fever). These patients will be individuals seen in URMC Dermatology clinic for a non-infectious condition that does not affect the skin of the extremities. AD subjects must have moderate-to-severe disease defined as an Eczema Area and Severity Index (EASI) of ≥ 12. The psoriasis subjects will have moderate-to-severe disease defined as a Psoriasis Area and Severity Index of ≥ 7. The healthy controls will be recruited to be age- and gendermatched to those with inflammatory skin diseases. Subjects will be recruited from URMC Dermatology clinics at Red Creek and Collegetown.

Description

Inclusion Criteria:

• ≥13 to 65 years of age (inclusive) for PS, ≥13 for AD and NA, male or female
• Optional Bx sub study - only adults (18-65 yrs; inclusive only)
• Able to understand protocol and give consent
• Able to keep clinic/study appointments and comply with study related procedures
• Must be able to read, speak, and understand English
• Chronic AD, according to the American Academy of Dermatology (AAD) Consensus Criteria (Eichenfield 2014), that has been present for at least 1 year before the enrollment visit
• Chronic PS, according to the AAD Consensus Criteria (Menter et al 2008 (section 1)), that has been present for at least 1 year before the enrollment visit.
• AD subjects: have active lesions on upper extremities, lower extremities, or trunk and a total disease severity of high moderate-to-severe (EASI ≥12)
• PS subjects: have active lesions on upper extremities, lower extremities, or trunk and a total disease severity of high moderate-to-severe (PASI ≥7)

Exclusion Criteria:

• Unwilling and/or unable to complete informed consent process
• <13 or > 65 years of age for PS, >13 for AD and NA
• AD subjects: disease without upper extremity, lower extremity, or trunk lesions
• AD subjects: total disease severity less than moderate (EASI <12), depending on enrollment
• PS subjects: disease without upper extremity, lower extremity, or trunk lesions
• PS subjects: total disease severity less than moderate (PASI <7), depending on enrollment
• Control subjects: diagnosed with an inflammatory skin disease
• Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the individual's participation in the study (Ex: HIV infection, autoimmune disease, severe heart failure, Hx of malignancy (other than in situ cervical cancer or basosquamous skin cancer), etc.)
• Recent bacterial, fungal, or viral infection requiring systemic therapies (PO, IV or IM) within the last month.
• Subjects with a history of serious life-threatening reaction to tape or adhesives may be enrolled but cannot undergo Tape stripping procedure and will therefore only have a baseline TEWL measurement.
• (For Skin biopsy substudy only) - Subjects with history of keloid formation or allergy to lidocaine.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy control; No intervention Ages: 13-65 yrs of age (inclusive), all genders, races and ethnicities; Additional 66+ yrs of age group, all genders, races and ethnicities	Other: Healthy control visit sampling procedures; Skin swabs for microbial analysis, Tape stripping and transepidermal water loss measurements (TEWL) with tape stripping (all patients) to assess skin barrier function, blood serum (adults & optional for adolescents), and optional biopsy (adults only)
Psoriasis; Intervention is whatever Rx the URMC dermatologist thinks is best suited to the subject as part of "real-world" disease management in her clinic. Ages:13-65 yrs of age (inclusive), all genders, races and ethnicities.	Other: PS subject visit sampling procedures; Skin swabs for microbial analysis, Tape stripping and transepidermal water loss measurements (TEWL) with tape stripping (all patients) to assess skin barrier function, and blood serum (optional for all PS subjects)
Atopic Dermatitis; Intervention is whatever Rx the URMC dermatologist thinks is best suited to the subject as part of "real-world" disease management in her clinic. 1. Ages: 1. 13-65 yrs of age (inclusive), all genders, races and ethnicities 2. Additional 66+ yrs of age group, all genders, races and ethnicities	Other: AD subject visit sampling procedures; Skin swabs for microbial analysis, Tape stripping and transepidermal water loss measurements (TEWL) with tape stripping (all patients) to assess skin barrier function, blood serum (adults & optional for adolescents), and optional biopsy (adults only)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abundance of colony forming units (rCFU/cm^2, and CFU/rCFU) of Staphylococcus aureus (S. aureus)	The abundance of S. aureus, and other microbes of interest including, but not exclusive to, coagulase-negative Staphylococcus species [CONS], and C. acnes present on the skin surface varies as a function of time and/or disease activity in AD and two control groups, namely plaque stage psoriasis (PS) and healthy, non-atopics (NA). Standard culture techniques will be utilized to measure rCFU/cm^2, and qPCR for CFU/rCFU.	year 1-7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify serum biomarker (or biomaker panel) that associates with disease severity or S. aureus abundance	Serum collected longitudinally will be measured by a multianalyte method	Years 3-5
Measure S. aureus virulence factors from skin swabs	We will determine whether any one or panel of these S. aureus virulence factors associate with AD or PS severity, barrier function or serum biomarkers	Years 3-5
Measure host/patient biomarkers from skin tape strips (or skin swabs)	We will evaluate whether host response to bacteria are increased in tape strips or skin swabs as a function of reductions in S. aureus abundance.	Years 3-5

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: Lisa A Beck, MD, University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2019
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 18, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: staphylococcus, microbiome, atopic dermatitis, cutibacterium
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases, Papulosquamous; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Psoriasis; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: STUDY00003830

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No