Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
100 participants
OBSERVATIONAL
2019-02-20
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
If the subject takes occasional Aspirin (not taken daily), it will need to be withheld for seven days prior to visit 2.
If the subject takes oral antihistamines, it will need to be withheld for seven days prior to the subject's first appointment.
If the subject takes oral antibiotics, inform the subject the appointment can be scheduled seven days after their last dose of antibiotic has been taken.
If the subject takes topical medications including (but not restricted to), cyclosporine, Elidel, Protopic, topical corticosteroids and topical antibiotics, it will need to be withheld seven days prior to the subject's first appointment.
If the subject takes any of the following medications, they are not eligible for enrollment:
Oral corticosteroids Any systemic immunosuppressive or immunomodulary 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
Visit 2: Will occur approximately 7 days following the screening visit or the phone call. If the subject was contacted via phone, he/she will be review and sign the informed consent form during this visit. The following procedures will be performed.
Urine Pregnancy Test: All female can be pregnant or become pregnant during the study. The urine pregnancy test will be administered to all women of child bearing potential. If the test will be positive, the participation in the study will be terminated.
Skin Biopsies: The skin biopsies will involve taking a small piece of skin (4 biopsies 2mm in diameter) generally obtained from the arms or legs, the face is excluded from skin biopsy. The area will be cleaned and numbed with a local anesthetic. Biopsies will be collected from non-lesion skin and acute lesions. The wound will not require a stitch and should be healed within two weeks. The biopsy site needs to be kept sterile and this will require that the area not get wet. The skin biopsies will be performed by one of the physician investigators or nurse practitioners. The subject will be given the name and phone number of a nurse and told to call if there are any problems. The subject will be given instructions on how to care for the biopsy site.
Venipuncture: 7.5 mL of blood will be removed by putting a needle into a vein. The procedure will be performed by a physician investigator or a nurse in the CTRC. The subject will be given the name and phone number of a nurse and told to call if there are any problems. There will not be any follow-up for venipuncture procedures.
DNA testing: Additional 7.5 ml of blood will be obtained for genetic testing of filaggrin gene polymorphisms (performed by ADx lab at NJH).
Skin cultures: Skin is rubbed with a cotton swab then cells are placed in a special culture medium tube for identification of bacteria wabs will be tested for presence of S. aureus by culture and PCR.
Tape Stripping. Adhesive skin sampling discs will be firmly pressed against the skin in a hairless location (not the face) followed by lifting it free of the skin. Skin tapes will be collected from non-lesion skin and acute skin lesions. This will be repeated up to 40 times. These discs will then be used to evaluate RNA, lipids and proteins in the upper layers of skin. With every 5 tape strips collected from one lesion and one non-lesion area skin barrier assessment will be preformed.
Skin Barrier Assessment. Skin serves as the first barrier against allergens, viruses, and bacteria that may aggravate your skin disease. A small device will be used to measure the quantity of water that passes from inside the body through the skin to the surrounding atmosphere via diffusion and evaporation process. Additionally, the device will measure skin pH, which is also associated with changes in the skin barrier.
Sweat Test. We will measure chemicals in patients' sweat, such as salt, which is known as a sweat test. To collect the sweat, a sticky pad will be attached to the skin on patients' arm for 5 minutes. A gel containing a medicine called pilocarpine is put on the pads and causes the sweat glands to produce more sweat. The pads are then removed and replaced by a disc to collect sweat for about 30 minutes.
Sebum Collection. Skin surface will be cleaned with alcohol wipes. After allowing skin surface to dry sebum collecting tape will be applied to the skin surface. The tape will be held on the skin surface for one hour. The tape will then be used to evaluate skin sebum production.
Optional Visits: The research team may ask the subject to return every 6 weeks and participate in additional skin biopsies, tape strips and blood draws (not to exceed 6.5 tablespoons (100 ml)). The subject may choose to participate in some or all optional visits not to exceed 6 additional blood draws, tape strips and/or biopsies in one year.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
atopic dermatitis
up to 40 subjects with atopic dermatitis will be enrolled into study.
No interventions assigned to this group
psoriasis
up to 20 subjects with psoriasis will be enrolled into study.
No interventions assigned to this group
people without skin conditions
Up to 40 subjects without skin conditions will be enrolled into study.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Jewish Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Donald Leung, MD, PhD
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Donald Leung, MD
Role: PRINCIPAL_INVESTIGATOR
National Jewish Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Jewish Health
Denver, Colorado, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HS-3008
Identifier Type: -
Identifier Source: org_study_id