The Role of Bacterial Toxins in Human Skin Disease

NCT02910791 | Unknown

• 1 other identifier: HS-3008
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Psoriasis

Outcome Measures

Primary Outcomes (1)

• To determine the molecular mechanisms by which cytokines in atopic dermatitis skin alters differentiation of skin keratinocytes

  one year

Study Arms (3)

atopic dermatitis

up to 40 subjects with atopic dermatitis will be enrolled into study.

psoriasis

up to 20 subjects with psoriasis will be enrolled into study.

people without skin conditions

Up to 40 subjects without skin conditions will be enrolled into study.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Jewish Health: lead

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic; Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Papulosquamous

Study Officials

• Donald Leung, MD

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donald Leung, MD

CONTACT

303-398-1186; leungd@njhealth.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 22, 2016
• Study Start: February 20, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

US (1)