Skin Microbial Ecology in Atopic Dermatitis

Launched by UNIVERSITY OF ROCHESTER · Nov 18, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the skin bacteria in people with atopic dermatitis (AD) and psoriasis (PS) to understand how these bacteria change with standard treatments. Researchers want to learn more about a specific type of bacteria called Staphylococcus aureus, which is often found in higher amounts on the skin of people with eczema, especially when their condition is flaring up. The goal is to see how the levels of this bacteria and other helpful skin bacteria are affected by treatment over time.

To participate in this study, you need to be between 13 and 65 years old and have chronic atopic dermatitis or psoriasis that has lasted for at least a year. Participants should have active skin lesions on their arms, legs, or trunk and meet certain severity criteria. If you join the trial, you’ll be asked to attend clinic appointments and undergo some tests to help researchers gather data about your skin condition. It's important to note that certain individuals, such as those with severe other health issues or specific skin conditions, may not be eligible. Overall, this study aims to improve our understanding of how skin bacteria relate to these skin diseases and their treatment.

Gender

ALL

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.