Skin Microbial Ecology in Atopic Dermatitis

Recruiting now

Conditions studied: Atopic Dermatitis, Psoriasis, Healthy

In brief

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.

Key facts

Study ID: NCT04170244
Run by: University of Rochester
People needed: 240
Starts: 2019-04-17
Expected to finish: 2027-04-01
Last updated by the study team: 2026-07-14

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

≥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)

You may not qualify if…

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 is running

University of Rochester Medical Center — Rochester, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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