Psoriasis Clinical Trial

Study of Skin Microbiome in AD and PS Patients

Summary

Everybody's skin has bacteria that normally lives on it. Previous research has shown that people with eczema have higher concentrations of a certain bacteria (S. aureus), especially when their disease is active. The purpose of this study is (a) to see if reductions in another skin bacteria (C. acnes) plays a role in the overgrowth of S. aureus in eczema patients, and (b) to examine how the types of bacteria present in the skin of patients with eczema or psoriasis change with disease activity. Less is known about the presence of S. aureus in psoriasis pts and how this impacts disease activity.

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Full 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/or production of lantibiotics) 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 (assessed by polymerase chain reaction [PCR]) of S. aureus, other relevant 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 serum biomarker (or panel) identifies subjects with greater S. aureus burden (e.g., abundance).

Aim 3 - Identify a serum biomarker (or panel) that predicts clinical improvement observed in our AD subjects.

Aim 4 - Quantify S. aureus virulence factors from skin swabs of all three subject populations.

Aim 5 - Develop a skin bacterial repository (optional). Aim 5.1 - Specifically focus on a repository of S. aureus, C. acnes, and CONS isolates from AD and PS patients, and age- and gender-matched healthy NAs.

Aim 5.2 - Determine if C. acnes isolates obtained from skin swabs of AD, PS, and NA patients exhibit anti-S. aureus properties in vitro by monitoring S. aureus growth curves in response to exposure to C. acnes or C. acnes-conditioned media.

Aim 5.3 - Perform whole genome DNA sequencing of C. acnes isolates from all patients to analyze whether C. acnes' genome harbors distinct gene(s) that correlate with the anti- S. aureus properties observed in Aim 5.2.

Aim 6 - Develop a repository of skin tape strips for biomarker and protease assays.

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Eligibility Criteria

Inclusion Criteria:

≥13 to 65 years of age (inclusive), male or female; can be 65+ in AD cohort
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, that has been present for at least 1 year before the enrollment visit
Chronic PS, according to the AAD Consensus Criteria, 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
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 and/or history of atopy (atopic dermatitis, allergic rhinitis, asthma, hay fever)
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.
Patients with a history of serious life-threatening reaction to tape or adhesives may be enrolled but cannot undergo transepidermal water loss (TEWL) measurements.
AD subjects 18 years or older and healthy control subjects only: unwilling and/or unable to undergo 30-cc blood draw

Study is for people with:

Psoriasis

Estimated Enrollment:

230

Study ID:

NCT04170244

Recruitment Status:

Recruiting

Sponsor:

University of Rochester

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There is 1 Location for this study

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University of Rochester Medical Center
Rochester New York, 14642, United States More Info
Lisa Beck, MD
Contact
585-275-7546
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Estimated Enrollment:

230

Study ID:

NCT04170244

Recruitment Status:

Recruiting

Sponsor:


University of Rochester

How clear is this clinincal trial information?

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