Immune Signature of Palmoplantar Pustulosis (PPP)

July 9, 2014 updated by: Baylor Research Institute

The Immune Signature of Palmoplantar Pustulosis

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75246
        • Menter Dermatology Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gene expression profiles
Time Frame: 2 years
To assess gene expression profiles in the skin and blood of patients with palmoplantar pustulosis compared with those of healthy controls.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examine leukocyte subsets in PPP
Time Frame: 2 years
To examine leukocyte subsets in the blood of patients with palmoplantar pustulosis compared to healthy controls.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Collaborators

Janssen Services, LLC
Dermatology Research Institute

Investigators

  • Principal Investigator: Alan Menter, MD, Baylor Research Institute, Menter Dermatology Research Institute, Texas Dermatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

January 29, 2013

First Submitted That Met QC Criteria

January 30, 2013

First Posted (Estimate)

January 31, 2013

Study Record Updates

Last Update Posted (Estimate)

July 10, 2014

Last Update Submitted That Met QC Criteria

July 9, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012-275

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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