Skin Microbial Ecology in Atopic Dermatitis

NCT04170244 | Recruiting

• 1 other identifier: STUDY00003830
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atopic Dermatitis; Psoriasis; Healthy

Keywords

staphylococcus, microbiome, atopic dermatitis, cutibacterium

Outcome Measures

Primary Outcomes (1)

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

  The abundance of S. aureus, and other microbes of interest including, but not exclusive to, coagulase-negative Staphylococcus species \[CONS\], and C. acnes present on the skin surface varies as a function of time and/or disease activity in AD and two control groups, namely plaque stage psoriasis (PS) and healthy, non-atopics (NA). Standard culture techniques will be utilized to measure rCFU/cm\^2, and qPCR for CFU/rCFU.

  year 1-7

Study Arms (3)

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

Other: AD subject visit sampling procedures

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

Other: Healthy control visit sampling procedures

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.

Other: PS subject visit sampling procedures

Interventions

AD subject visit sampling procedures OTHER

Skin 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)

Atopic Dermatitis

PS subject visit sampling procedures OTHER

Skin 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)

Psoriasis

Healthy control visit sampling procedures OTHER

Skin 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)

Healthy control

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The healthy population will be defined as individuals with no personal history of or active case of any atopic disorder (e.g. atopic dermatitis, allergic rhinitis, asthma, hay fever). These patients will be individuals seen in URMC Dermatology clinic for a non-infectious condition that does not affect the skin of the extremities. AD subjects must have moderate-to-severe disease defined as an Eczema Area and Severity Index (EASI) of ≥ 12. The psoriasis subjects will have moderate-to-severe disease defined as a Psoriasis Area and Severity Index of ≥ 7. The healthy controls will be recruited to be age- and gendermatched to those with inflammatory skin diseases. Subjects will be recruited from URMC Dermatology clinics at Red Creek and Collegetown.

You may qualify if:

• ≥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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

All subjects will have skin swabs and tape strips (done as part of barrier measurements) collected/banked and adult AD subjects will also have serum banked and a small subset of adult (AD and NA) will undergo skin biopsies

MeSH Terms

Conditions

Dermatitis, Atopic; Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Papulosquamous

Central Study Contacts

Dermatology clinical trials unit

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: April 17, 2019
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-05

Locations

US (1)