Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02910791 |
| Other study ID # |
HS-3008 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 20, 2019 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
October 2021 |
| Source |
National Jewish Health |
| Contact |
Donald Leung, MD |
| Phone |
303-398-1186 |
| Email |
leungd[@]njhealth.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Visit 1 (if needed). Study subjects will be asked to read and sign the informed consent. At
that time the study inclusion and exclusion criteria for the study will be reviewed. Subject
will be given instructions to stop taking certain medications for 7 days prior to the next
study visit. Alternatively, if Visit 1 will be done over the phone, subjects may be contacted
via phone using a phone script to provide instructions for stopping these medications. In
this case, the informed consent will be obtained by the subject at visit 2 prior to any study
procedures being done.
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.
