Understanding skin bacteria in patients with eczema and psoriasis
Longitudinal "Real-World" Changes in Skin Microbial Ecology in Atopic Dermatitis (AD) and Psoriasis (PS) Patients
This study is trying to see how skin bacteria affect people with eczema and psoriasis to better understand their skin health and treatment responses.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 13 Years and up |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT04170244 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the role of skin bacteria, particularly Staphylococcus aureus, in patients with atopic dermatitis (AD) and psoriasis (PS). By monitoring changes in bacterial abundance and skin health over time, the study seeks to identify biomarkers that correlate with disease severity and treatment response. Participants will include individuals with chronic AD and PS, as well as healthy controls, with various sampling procedures conducted to gather data on skin microbiome dynamics. The study will also explore the potential for developing a microbial repository for future research.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 13 to 65 with chronic atopic dermatitis or psoriasis that has been present for at least one year.
Not a fit: Patients with mild or non-chronic forms of atopic dermatitis or psoriasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of skin conditions like eczema and psoriasis through targeted therapies.
How similar studies have performed: While studies on the skin microbiome are emerging, this specific approach focusing on the interplay of S. aureus and other bacteria in AD and PS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rochester, New York
- University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
Study contacts
- Study coordinator: Dermatology clinical trials unit
- Email: DermCTU_Appointments@URMC.Rochester.edu
- Phone: 585-273-4195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.