Palmoplantar Pustulosis Clinical Trial
— PPPOfficial title:
The Immune Signature of Palmoplantar Pustulosis
Verified date | July 2014 |
Source | Baylor Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
This study is being done to learn more about a less common "type" of psoriasis, called
palmoplantar pustulosis (PPP). The majority of the current treatments used for this type of
psoriasis have only a moderate effect on PPP. Thus, the investigators believe that PPP may
be a different disease entity altogether, requiring different therapies. As such, the
investigators hope to discover an immune signature for this condition.
An immune "signature" is the unique way in which the combination of genes, cells, and
proteins of the immune system work for each person. Because both psoriasis and the type of
psoriasis patients have been diagnosed with, PPP, are conditions of abnormal immune system
function, it is important to understand the overall function of the immune system in this
condition (that is, find the immune "signature"). This study should help identify an immune
system "signature" in people with PPP.
The investigators have a laboratory technology which allows them to read the genetic
"signatures" of a person's blood cells. Genes contain the instructions for making living
things. Genes are contained in the cells' DNA (deoxyribonucleic acid). Most DNA is the same
among humans, but the small differences people have in their DNA may explain why people
develop different diseases. DNA and the genes it contains help produce RNA (ribonucleic
acid), which in turn helps make proteins in people's cells. Differences in the types of
proteins and the amount of those different proteins people's cells produce can affect a
person's immune system.
To help the investigators determine the immune "signature" in PPP, they will be examining
the different genes, cells, and proteins that are active in patients with PPP versus
patients who do not have the condition. The investigators will examine these genes, cells,
and proteins in skin (through a skin sample) and in blood (through a blood draw). The goal
is to develop new treatments for this skin condition. To do this, the investigators need to
compare the skin and blood of patients with this particular type of psoriasis to the samples
of healthy patients.
Status | Completed |
Enrollment | 30 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Subjects must give written informed consent. - Subjects are age 18 years or older, with a diagnosis of palmoplantar pustulosis (PPP) or be a healthy control. - Subjects must be able to adhere to the study visit schedule and other protocol requirements. - Patient must be off systemic psoriasis therapies (e.g. retinoids, phototherapy, methotrexate, cyclosporine etc.) for at least 4 weeks, biologic therapies for 12 weeks (or 24 weeks in the case of ustekinumab) and off topical therapies (e.g. calcipotriene, topical steroids) for at least 2 weeks. Exclusion Criteria: - Inability to provide informed consent. - Patient is unwilling to be off systemic psoriasis therapies for at least 4 weeks, biologic therapies for 12 weeks (or 24 weeks in the case of ustekinumab) or off topical therapies for at least 2 weeks. - Unwilling to consent to skin biopsy or blood draw. - Are pregnant, nursing, or planning a pregnancy while enrolled in the study. - Uncontrolled medical conditions (diabetes, liver disease, renal disease). - Have a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening or have had a non-tuberculous mycobacterial infection or opportunistic infection (e.g., cytomegalovirus, pneumocystosis, aspergillosis) within 6 months prior to screening. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Menter Dermatology Research Institute | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor Research Institute | Dermatology Research Institute, Janssen Services, LLC |
United States,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gene expression profiles | To assess gene expression profiles in the skin and blood of patients with palmoplantar pustulosis compared with those of healthy controls. | 2 years | No |
Secondary | Examine leukocyte subsets in PPP | To examine leukocyte subsets in the blood of patients with palmoplantar pustulosis compared to healthy controls. | 2 years | No |
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