Study of Skin Microbiome in AD and PS Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 13 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04170244
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Rochester
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Atopic Dermatitis, Psoriasis
Additional Details

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.

Arms & Interventions

Arms

: 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. Ages:13-65 yrs of age, all genders, races and ethnicities Additional 65+ age group, all genders, races and ethnicities

: Healthy control

No intervention Ages:13-65 yrs of age, all genders, races and ethnicities

: 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, all genders, races and ethnicities

Interventions

Other: - Skin swab, TEWL with tape stripping, and serum (adults)

Skin will be swabbed to collect samples for bacterial analysis. Transepidermal water loss (TEWL) will be measured at 4 time points: before tape stripping, after application of 5 D-squame tapestrips, after application of 10 D-squame tapestrips, and after application of 15 D-squame tapestrips (total tapestrips per site = 15).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Rochester Medical Center, Rochester, New York

Status

Recruiting

Address

University of Rochester Medical Center

Rochester, New York, 14642

Site Contact

Lisa Beck, MD

lisa_beck@urmc.rochester.edu

585-275-7546

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