NCT04170244Recruiting
Skin Microbial Ecology in Atopic Dermatitis
Longitudinal "Real-World" Changes in Skin Microbial Ecology in Atopic Dermatitis (AD) and Psoriasis (PS) Patients
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 240 (estimated)
- First submitted
- 18 Nov 2019
- Start date
- 17 Apr 2019
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- University of Rochester
- Diseases
- Atopic dermatitis (eczema), Psoriasis
- NCT number
- NCT04170244
What you commit to
- Study type: Observational
- Planned participants: 240
- From 17 Apr 2019 to the primary completion date, 1 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.)
Other illness
- 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
- 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.
Age
- \<13 or \> 65 years of age for PS, \>13 for AD and NA
Other
- Unwilling and/or unable to complete informed consent process
Who the study is looking for
- ≥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)
Age in the registry: 13 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.