Longitudinal Real-World Changes in Skin Microbial Ecology in Atopic Dermatitis (AD) and Psoriasis (PS) Patients

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Healthy Volunteers: t
View:

• ≥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)

Locations
United States
New York
University of Rochester Medical Center
RECRUITING
Rochester
Contact Information
Primary
Dermatology clinical trials unit
DermCTU_Appointments@URMC.Rochester.edu
585-273-4195
Time Frame
Start Date: 2019-04-17
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 240
Treatments
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.
Authors
Lisa A Beck
Related Therapeutic Areas
Sponsors
Leads: University of Rochester

This content was sourced from clinicaltrials.gov