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Clinical Trial Details for The Role of Bacterial Toxins in Human Skin Disease


National Jewish Health
NCT ID: NCT02910791
Last Updated: September 19, 2016

The Study at a Glance

  • Status: Recruiting
  • Phase:
  • Gender: All
  • Age: 18 Years - 65 Years
  • Condition:
    • Atopic Dermatitis
    • Psoriasis
  • Study Type: Observational
  • Intervention:
  • Lead Sponsor: National Jewish Health
  • Location: Not Provided

Official Title

The Role of Bacterial Toxins in Human Skin Disease

Purpose

Atopic dermatitis and psoriasis are two skin diseases often associated with bacterial infections and inflammation. Studies indicate that skin cells from these patients may have some changes that make these patients more susceptible to bacterial infections. Inflammatory environment may have an effect on the function of skin cells.The purpose of this study is to learn more about skin cells (keratinocytes and fibroblasts) and how they regulate skin barrier function. To study this we need to establish skin cells that can be grown in the laboratory. We will use small skin biopsies from patients with atopic dermatitis, psoriasis and healthy people as a source of these cells. Since these skin cells have a limited lifetime when grown in laboratory as part of the project we would like to modify them, which allows them to grow for long time in the research laboratory. Some of the collected skin biopsies and isolated skin cells will be used to examine what gene products they make.

Eligibility

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Population

The subject population will consist of adults (18-65 years old) with AD, psoriasis or
healthy controls with no history of chronic skin diseases and atopy. Recruitment will aim
for up to 40 subjects with AD, up to 20 subjects with psoriasis, and up to 40 healthy
normal controls.

Criteria

Inclusion Criteria:

– If subjects takes occasional Aspirin (not taken daily), it will need to be withheld
for seven days prior to Visit 2.

– If subjects takes oral antihistamines, it will need to be withheld for seven days
prior to the subject’s first appointment

– If subjects takes topical medications including (but not restricted to), cyclosporine,
Elidel, Protopic, topical corticosteroids and topical antibiotics, it will need to
withheld seven days prior to the subject’s first appointment.

Exclusion Criteria:

– Women can not be pregnant or become pregnant during the study

– Oral corticosteroids:

– Any systemic immunosuppressive or immunomodulatory medication in the last 28
days.

– Patients who have received immunotherapy in the past year.

– Patients using anxiolytics or antidepressants

– Antiviral therapies

– Anticoagulants

– Allergic to lidocaine

– Daily Aspirin use

Additional Information, Locations & Contacts

Sponsors & Collaborators

National Jewish Health

Investigators

Principal Investigator: Donald Leung, MD

National Jewish Health

Please refer to this study by its ClinicalTrials.gov identifier: NCT02910791

Location

Contacts

National Jewish Health

Denver, Colorado 80206

United States