Understanding skin bacteria in patients with eczema and psoriasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the role of skin bacteria, particularly Staphylococcus aureus, in patients with atopic dermatitis (AD) and psoriasis (PS). By monitoring changes in bacterial abundance and skin health over time, the study seeks to identify biomarkers that correlate with disease severity and treatment response. Participants will include individuals with chronic AD and PS, as well as healthy controls, with various sampling procedures conducted to gather data on skin microbiome dynamics. The study will also explore the potential for developing a microbial repository for future research.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Rochester Medical Center
  Rochester, New York, United States Recruiting

Study contacts

• Study coordinator: Dermatology clinical trials unit
• Email: DermCTU_Appointments@URMC.Rochester.edu
• Phone: 585-273-4195

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.