Skin Microbial Ecology in Atopic Dermatitis
Recruiting · NCT04170244 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Rochester
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
2 locations listed across 1 US state.
- University of Rochester Medical Center - Rochester, New York, United States
- University of Rochester Medical Center - Rochester, New York, United States