Study of Skin Microbiome in AD and PS Patients

  • STATUS
    Recruiting
  • End date
    Apr 1, 2024
  • participants needed
    195
  • sponsor
    University of Rochester
Updated on 2 January 2022
staphylococcus aureus
psoriasis
atopy
eczema
dermatitis
Accepts healthy volunteers

Summary

Everybody's skin has bacteria that normally lives on it. Previous research has shown that people with eczema have higher concentrations of a certain bacteria (S. aureus), especially when their disease is active. The purpose of this study is (a) to see if reductions in another skin bacteria (C. acnes) plays a role in the overgrowth of S. aureus in eczema patients, and (b) to examine how the types of bacteria present in the skin of patients with eczema or psoriasis change with disease activity. Less is known about the presence of S. aureus in psoriasis pts and how this impacts disease activity.

Details
Condition Atopic Dermatitis, Psoriasis
Treatment Skin Swab, Skin swab and serum (adults)
Clinical Study IdentifierNCT04170244
SponsorUniversity of Rochester
Last Modified on2 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

≥13 to 65 years of age (inclusive), male or female
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, that has been present for at least 1 year before the enrollment visit
Chronic PS, according to the AAD Consensus Criteria, 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
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
Patients with a history of serious life-threatening reaction to tape or adhesives may be enrolled but cannot undergo optional TEWL measurements
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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