Longitudinal "Real-World" Changes in Skin Microbial Ecology in Atopic Dermatitis (AD) and Psoriasis (PS) Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Abundance of colony forming units (rCFU/cm^2, and CFU/rCFU) of Staphylococcus aureus (S. aureus)
研究概览
简要总结
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.
详细描述
Although the two most common inflammatory skin diseases (AD and Psoriasis) are now quite effectively managed with topical and/or systemic therapies, how this disease improvement is reflected in changes of skin microbial pathogens and commensals is still not well understood. We have several aims.
Aim 1 - Determine how the abundance of S. aureus, other microbes of interest including, but not exclusive to, coagulase-negative Staphylococcus species [CONS], and C. acnes on the skin surface varies as a function of time and/or disease activity in AD, plaque stage psoriasis (PS) and healthy, non-atopics (NA). Aim 2 - Validate whether a biomarker (or panel) identifies subjects with greater S. aureus burden (e.g., abundance). Aim 3 - Identify a biomarker (or panel) that predicts clinical improvement observed in our AD or PS subjects. Aim 4 - Quantify S. aureus virulence factors from skin swabs of all three subject populations. Exploratory Aim 5 - Develop a skin microbial repository (optional) where we will focus on the interplay between S. aureus and other microbes from AD and PS patients, and age- and gender-matched healthy NAs. Exploratory Aim 6 - Develop a repository of skin tape strips for biomarker and protease assays. Exploratory Aim 7 - (optional enrollment) - To identify skin epithelial gene signatures from AD skin that are unique and not found in healthy non- AD, NA control skin samples after they are infected ex vivo with HSV-1. A secondary goal of this work will be to evaluate how Real-World treatment(s) affect these observations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥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)
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: PS subject visit sampling procedures (Other)
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
干预措施: AD subject visit sampling procedures (Other)
Healthy control
No intervention
Ages:
- 13-65 yrs of age (inclusive), all genders, races and ethnicities
- Additional 66+ yrs of age group, all genders, races and ethnicities
干预措施: Healthy control visit sampling procedures (Other)
结局指标
主要结局
Abundance of colony forming units (rCFU/cm^2, and CFU/rCFU) of Staphylococcus aureus (S. aureus)
时间窗: year 1-7
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.
次要结局
未报告次要终点
研究者
Lisa Beck
Professor
University of Rochester