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The Role of Bacterial Toxins in Human Skin Disease

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ClinicalTrials.gov Identifier: NCT02910791
Recruitment Status : Recruiting
First Posted : September 22, 2016
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Donald Leung, MD, PhD, National Jewish Health

Brief Summary:

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.


Condition or disease Intervention/treatment
Atopic Dermatitis Psoriasis Procedure: blood draw/skin biopsy

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Role of Bacterial Toxins in Human Skin Disease
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
atopic dermatitis
up to 40 subjects with atopic dermatitis will be enrolled into study.
Procedure: blood draw/skin biopsy
psoriasis
up to 20 subjects with psoriasis will be enrolled into study.
Procedure: blood draw/skin biopsy
people without skin conditions
Up to 40 subjects without skin conditions will be enrolled into study.
Procedure: blood draw/skin biopsy



Primary Outcome Measures :
  1. To determine the molecular mechanisms by which cytokines in atopic dermatitis skin alters differentiation of skin keratinocytes [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910791


Contacts
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Contact: Donald Leung, MD 303-398-1186 leungd@njhealth.org

Locations
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United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
Investigators
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Principal Investigator: Donald Leung, MD National Jewish Health
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Responsible Party: Donald Leung, MD, PhD, Principal Investigator, National Jewish Health
ClinicalTrials.gov Identifier: NCT02910791    
Other Study ID Numbers: HS-3008
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Dermatitis, Atopic
Psoriasis
Dermatitis
Skin Diseases
Skin Diseases, Papulosquamous
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases