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 : October 19, 2021
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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 |
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Atopic Dermatitis Psoriasis |

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 : | February 20, 2019 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2023 |

Group/Cohort |
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atopic dermatitis
up to 40 subjects with atopic dermatitis will be enrolled into study.
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psoriasis
up to 20 subjects with psoriasis will be enrolled into study.
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people without skin conditions
Up to 40 subjects without skin conditions will be enrolled into study.
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- To determine the molecular mechanisms by which cytokines in atopic dermatitis skin alters differentiation of skin keratinocytes [ Time Frame: one year ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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
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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

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
Contact: Donald Leung, MD | 303-398-1186 | leungd@njhealth.org |
United States, Colorado | |
National Jewish Health | Recruiting |
Denver, Colorado, United States, 80206 |
Principal Investigator: | Donald Leung, MD | National Jewish Health |
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: | October 19, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Dermatitis, Atopic Psoriasis Dermatitis Skin Diseases Skin Diseases, Papulosquamous Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |