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Clinical Trial Summary

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.


Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01780857
Study type Observational
Source Baylor Research Institute
Contact
Status Completed
Phase N/A
Start date June 2013
Completion date July 2014

See also
  Status Clinical Trial Phase
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Completed NCT04572997 - Apremilast in Patients With Moderate to Severe Palmoplantar Pustulosis (PPP) (APLANTUS) Phase 2
Completed NCT03633396 - A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Palmoplantar Pustulosis Phase 2
Active, not recruiting NCT05174065 - Phase 3, Randomized Study of Apremilast in Japanese Participants With Palmoplantar Pustulosis (PPP) Phase 3
Active, not recruiting NCT04459507 - A Registry Study of Palmoplantar Pustulosis (PPP) Treatment Patterns, Disease Burden and Treatment Outcomes in Japan
Completed NCT03972280 - Safety and Pharmacokinetics of Repeat Doses of CSL324 in Subjects With Hidradenitis Suppurativa and Palmoplantar Pustulosis Phase 1
Completed NCT01794117 - Anakinra for Inflammatory Pustular Skin Diseases Phase 2
Recruiting NCT05710185 - Deucravacitinib for the Treatment of Palmoplantar Pustulosis Phase 4
Terminated NCT05194839 - A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP) Phase 2
Active, not recruiting NCT04566471 - Palmoplantar Pustulosis and Generalized Pustular Psoriasis: A National Population-based Analysis of Prevalence
Completed NCT03988335 - A Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP) Phase 2
Completed NCT02641730 - An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis Phase 3
Completed NCT04061252 - A Study of KHK4827 in Subjects With Palmoplantar Pustulosis Phase 3