Skin Microbial Ecology in Atopic Dermatitis
Longitudinal "Real-World" Changes in Skin Microbial Ecology in Atopic Dermatitis (AD) and Psoriasis (PS) Patients
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 13 Years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at how bacteria on the skin change during usual treatment for eczema and psoriasis. It focuses on a germ called S. aureus and other bacteria that normally live on skin. It includes people with eczema or psoriasis and a control group for comparison.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- For psoriasis: ages 13–65. For eczema and the group labeled “NA”: age 13 or older. The listing does not explain “NA” and gives conflicting age rules below.
- For the optional skin biopsy study, which takes a small skin sample: ages 18–65 only.
- Able to understand the study and give consent.
- Able to attend visits and follow study steps.
- Able to read, speak, and understand English.
- For eczema or psoriasis: have had the condition for at least 1 year and meet the listed medical guidelines for diagnosis.
- For eczema: active skin patches on the arms, legs, or body, with a severity score called EASI of at least 12.
- For psoriasis: active skin patches on the arms, legs, or body, with a severity score called PASI of at least 7.
Who can't join
- For psoriasis: younger than 13 or older than 65. For eczema and “NA,” this section excludes people older than 13, which conflicts with the inclusion rules. Ask the study team to confirm.
- Unable or unwilling to complete the consent process.
- For eczema or psoriasis: no active patches on the arms, legs, or body. Lower severity scores may also rule you out, depending on enrollment.
- For control group members: a diagnosed skin disease that causes inflammation.
- A serious illness that the study doctor thinks would make taking part unsafe or difficult.
- A recent bacterial, fungal, or viral infection treated with medicine by mouth or injection within the past month.
- A past life-threatening reaction to tape or glue does not rule out joining, but you cannot have tape stripping. You would only have the starting measurement of water loss through the skin.
- For the skin biopsy study only: a history of thick, raised scars called keloids, or an allergy to lidocaine, a numbing medicine.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
NY
- University of Rochester Medical Center · Rochester, NY 14642Lisa Beck, MD · Study contact · 585-275-7546 · lisa_beck@urmc.rochester.eduMore trials in Rochester