Study of Skin Microbiome in AD and PS Patients

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04170244
• Other study ID #: STUDY00003830
• Status: Recruiting
• Start date: April 17, 2019
• Est. completion date: April 1, 2026

Study information

• Verified date: June 2024
• Source: University of Rochester
• Contact: Kimberly Leffler
• Phone: 585-273-4195
• Email: kimberly_leffler[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

We believe that as this skin diseases (AD and Psoriasis) are effectively managed with topical and/or systemic therapies, the levels of C. acnes (and other commensal bacteria with anti-S. aureus actions) will increase and this will subsequently be followed by reductions in S. aureus and these changes will be reflected in skin barrier improvements and changes in biomarkers. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Psoriasis

Intervention

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)
• 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)
• 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)

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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