Recruiting

Observational Study

Sponsor:

National Jewish Health

Code:

NCT02910791

Conditions

Atopic Dermatitis

Psoriasis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT02910791

Start date

Feb 20, 2019

Status verified date

Oct, 2021

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • To determine the molecular mechanisms by which cytokines in atopic dermatitis skin alters differentiation of skin keratinocytes [ Time Frame: one year ]

Central Contacts and Locations

Central contacts

Donald Leung, MD

303-398-1186leungd@njhealth.org

Locations

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

More Information

Sponsor

National Jewish Health

Last update posted

Oct 19, 2021

Last verified

Oct, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Jewish Health on 2021-10-19.