Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Immune Signature of Palmoplantar Pustulosis (PPP)

This study has been completed.
Sponsor:
Collaborators:
Janssen Services, LLC
Dermatology Research Institute
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT01780857
First received: January 29, 2013
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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.


Condition
Palmoplantar Pustulosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Immune Signature of Palmoplantar Pustulosis

Resource links provided by NLM:


Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • Gene expression profiles [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To assess gene expression profiles in the skin and blood of patients with palmoplantar pustulosis compared with those of healthy controls.


Secondary Outcome Measures:
  • Examine leukocyte subsets in PPP [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To examine leukocyte subsets in the blood of patients with palmoplantar pustulosis compared to healthy controls.


Biospecimen Retention:   Samples With DNA

Blood and tissue samples. Blood from PPP patients. Skin biopsies from affected palms and soles.


Estimated Enrollment: 30
Study Start Date: June 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
PPP patients
Patients with palmoplantar pustulosis who have had blood and tissue samples taken.
Healthy controls
Patients without palmoplantar pustulosis or any inflammatory skin condition who have had blood and tissue samples taken.

Detailed Description:

I. SPECIFIC AIM

Specific Aim. To identify transcriptional signatures in the skin and blood of patients with palmoplantar pustulosis (PPP).

II. BACKGROUND AND SIGNIFICANCE

Despite major advances in elucidating the molecular pathways of chronic plaque psoriasis (CPP), the immunopathogenesis of PPP, a less common "variant" of psoriasis, remains elusive. It is characterized by the development of inflammatory sterile pustules on the palms and soles of affected individuals, which can be exceptionally painful, interfering with walking and manual activities and impinging significantly on quality of life. Current systemic and biologic treatments used to treat CPP have only a moderate effect in patients with PPP, supporting the suggestion that PPP is a separate disease entity with a distinct immunopathogenic basis. Moreover, the spontaneous paradoxical development of PPP is frequently observed in patients treated with anti-tumor necrosis factor-α therapies, agents typically used in the treatment of CPP. Genetic analysis also distinguishes patients with PPP from those with CPP.

At the investigators' institution, microarray analyses of blood transcriptional patterns have permitted crucial advances in characterizing the immunopathogenesis of immune-mediated conditions such as systemic lupus erythematosis and systemic-onset juvenile idiopathic arthritis. The investigators now wish to examine transcriptional profiles in the skin and blood of patients with PPP to identify the immunopathogenesis of this condition and identify potential therapeutic targets. The investigators will validate the findings at a cellular and protein level using flow cytometry, immunohistochemistry and measuring serum levels of proteins in the blood with Luminex or ELISA.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  1. Number of Subjects

    A total of 20 patients with palmoplantar pustulosis and 10 healthy controls will be enrolled in this study.

  2. Recruitment Procedures

Subjects will be recruited from: (1) the dermatology clinic at Texas Dermatology (in conjunction with Menter Dermatology Research Institute) which include patients seen in the clinic referred by the dermatologists providing their care, participants of clinical trials in the clinic, or previously screened participants for clinical trials referred by the study staff); (2) referrals from other dermatologists' or doctors' clinics.

Healthy volunteers will be recruited from the dermatology clinic. Where possible, healthy volunteers and PPP patients will be matched for sample collection location, gender, age and race.

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780857

Locations
United States, Texas
Menter Dermatology Research Institute
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
Janssen Services, LLC
Dermatology Research Institute
Investigators
Principal Investigator: Alan Menter, MD Baylor Research Institute, Menter Dermatology Research Institute, Texas Dermatology
  More Information

Publications:

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01780857     History of Changes
Other Study ID Numbers: 012-275
Study First Received: January 29, 2013
Last Updated: July 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor Research Institute:
palmoplantar pustulosis
psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on November 24, 2014