Recruiting

Skin MicrobiomeSkin Microbial Ecology in Atopic Dermatitis

Sponsor:

University of Rochester

Code:

NCT04170244

Conditions

Atopic Dermatitis

Psoriasis

Healthy

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Accepted

Interventions

AD subject visit sampling procedures

PS subject visit sampling procedures

Healthy control visit sampling procedures

Study Details

Brief summary:

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.

Conditions

Atopic Dermatitis

Psoriasis

Healthy

Study ID

NCT04170244

Start date

Apr 17, 2019

Status verified date

Jul, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

240 participants

Anticipated

Interventions and Outcome Measures

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.

1\. Ages: 1. 13-65 yrs of age (inclusive), all genders, races and ethnicities 2. Additional 66+ yrs of age group, all genders, races and ethnicities

Healthy control

No intervention

Ages:

1. 13-65 yrs of age (inclusive), all genders, races and ethnicities
2. Additional 66+ yrs of age group, 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 (inclusive), all genders, races and ethnicities.

Interventions

AD subject visit sampling procedures

Skin swabs for microbial analysis, Tape stripping and transepidermal water loss measurements (TEWL) with tape stripping (all patients) to assess skin barrier function, blood serum (adults \& optional for adolescents), and optional biopsy (adults only)

PS subject visit sampling procedures

Skin swabs for microbial analysis, Tape stripping and transepidermal water loss measurements (TEWL) with tape stripping (all patients) to assess skin barrier function, and blood serum (optional for all PS subjects)

Healthy control visit sampling procedures

Primary outcome measure

Abundance of colony forming units (rCFU/cm^2, and CFU/rCFU) of Staphylococcus aureus (S. aureus) [ Time Frame: year 1-7 ]

Central Contacts and Locations

Central contacts

Dermatology clinical trials unit

585-273-4195 DermCTU_Appointments@URMC.Rochester.edu

Locations

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Lisa Beck, MD

585-275-7546 lisa_beck@urmc.rochester.edu

More Information

Sponsor

University of Rochester

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

staphylococcus, microbiome, atopic dermatitis, cutibacterium

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-07-14.