Skin Microbial Ecology in Atopic Dermatitis
Part of paid clinical trials in Rochester, New York.
- Sponsor
- University of Rochester
- Study ID
- NCT04170244
- Status
- Recruiting
Conditions
- Atopic Dermatitis
- Healthy
- Psoriasis
Eligibility Criteria
- Sex
- ALL
- Age
- 13 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- AD subject visit sampling procedures — OTHERSkin 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 — OTHERSkin 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 — OTHERSkin 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)
Study Details
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 Dates
- Start date
- Apr 17, 2019
- Status verified
- May 2025
- Primary completion
- Mar 1, 2027
- Completion
- Apr 1, 2027
Study Design
- Enrollment
- 240 participants (estimated)
Arms
- Arm: Atopic DermatitisIntervention 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
- Arm: Healthy controlNo 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
- Arm: PsoriasisIntervention 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.
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
- Dermatology clinical trials unit585-273-4195
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 |
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