Study of Skin Microbiome in Atopic Dermatitis Patients

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 13 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

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 keloid formation or lidocaine allergy may be enrolled but cannot undergo optional skin biopsies.
  • - Patients with a history of serious life-threatening reaction to tape or adhesives may be enrolled but cannot undergo optional TEWL measurements.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04170244
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Rochester
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Atopic Dermatitis, Psoriasis
Arms & Interventions

Arms

: Atopic Dermatitis

: Healthy control

: Psoriasis

Interventions

Other: - Skin swab

Skin will be swabbed to collect samples for bacterial analysis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Rochester Medical Center, Rochester, New York

Status

Recruiting

Address

University of Rochester Medical Center

Rochester, New York, 14642

Site Contact

Lisa Beck, MD

[email protected]

585-275-7546

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