RecruitingNot Applicable

Skin Microbial Ecology in Atopic Dermatitis

United States240 participantsStarted 2019-04-17

Plain-language 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.

Who can participate

Age range

13 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Abundance of colony forming units (rCFU/cm^2, and CFU/rCFU) of Staphylococcus aureus (S. aureus)

Timeframe: year 1-7

Trial details

NCT IDNCT04170244

SponsorUniversity of Rochester

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-03-01

Contact for this trial

Dermatology clinical trials unit

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

View on ClinicalTrials.gov More Atopic Dermatitis trials