RECRUITING

Study of Skin Microbiome in AD and PS Patients

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Conditions

Atopic DermatitisPsoriasisstaphylococcus, microbiome, atopic dermatitis, cutibacterium

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-04-17
Study Completion:2026-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04170244

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥13 to 65 years of age (inclusive) for PS, ≥13 for AD and NA, male or female
  2. * Optional Bx sub study - only adults (18-65 yrs; inclusive only)
  3. * Able to understand protocol and give consent
  4. * Able to keep clinic/study appointments and comply with study related procedures
  5. * Must be able to read, speak, and understand English
  6. * 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
  7. * 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.
  8. * AD subjects: have active lesions on upper extremities, lower extremities, or trunk and a total disease severity of high moderate-to-severe (EASI ≥12)
  9. * PS subjects: have active lesions on upper extremities, lower extremities, or trunk and a total disease severity of high moderate-to-severe (PASI ≥7)
  1. * Unwilling and/or unable to complete informed consent process
  2. * \<13 or \> 65 years of age for PS, \>13 for AD and NA
  3. * AD subjects: disease without upper extremity, lower extremity, or trunk lesions
  4. * AD subjects: total disease severity less than moderate (EASI \<12), depending on enrollment
  5. * PS subjects: disease without upper extremity, lower extremity, or trunk lesions
  6. * PS subjects: total disease severity less than moderate (PASI \<7), depending on enrollment
  7. * Control subjects: diagnosed with an inflammatory skin disease
  8. * 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.)
  9. * Recent bacterial, fungal, or viral infection requiring systemic therapies (PO, IV or IM) within the last month.
  10. * 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.
  11. * (For Skin biopsy substudy only) - Subjects with history of keloid formation or allergy to lidocaine.

Contacts and Locations

Study Contact

Kimberly Leffler
CONTACT
585-273-4195
kimberly_leffler@urmc.rochester.edu

Study Locations (Sites)

University of Rochester Medical Center
Rochester, New York, 14642
United States

Collaborators and Investigators

Sponsor: University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-04-17
Study Completion Date2026-04-01

Study Record Updates

Study Start Date2019-04-17
Study Completion Date2026-04-01

Terms related to this study

Keywords Provided by Researchers

  • staphylococcus, microbiome, atopic dermatitis, cutibacterium

Additional Relevant MeSH Terms

  • Atopic Dermatitis
  • Psoriasis