Pilot Studies Testing Levels of P63 in Psoriasis Skin Lesions

April 18, 2023 updated by: Wright State University
The purpose of this study is to understand the role of a specific protein, tumor protein p63 in the skin disease psoriasis. This study is to further understand how psoriasis lesions happens. An understanding of key mediators that lead to psoriasis might aid in the discovery of more effective treatments for this skin disorder. This is not an intervention study. The study is looking to obtain currently untreated plaque psoriasis biopsies and also biopsies from non psoriasis patients. Psoriasis and medical history will be collected then skin biopsies will be obtained from the subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Ohio
      • Fairborn, Ohio, United States, 45324
        • Wright State Physicians

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 50 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Plaque psoriasis patients and control patients from the Dayton, OH area.

Description

Inclusion Criteria:

  • Female and Male adult subjects age 18 to 50 with plaque psoriasis that is currently untreated (no topical agents for 2 weeks, no systemic agents for 1 month) or controls w/o psoriasis and no family history of psoriasis.
  • Must be able to give informed consent
  • All skin types on Fitzpatrick Scale (Type I-VI)
  • Able to provide medical history and list of medications for psoriasis and control subjects

Exclusion Criteria:

  • Underlying diseases that could affect wound healing (e.g., uncontrolled diabetes mellitus)
  • Tanning bed use within last 2 months
  • Photodynamic Therapy or UVB treatments in past 2 months
  • Female Subjects: pregnant or nursing
  • History of abnormal scarring (i.e., keloids)
  • Family history of psoriasis in first-degree relatives for control subjects

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: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Psoriasis
Subjects diagnosed with psoriasis.
Other: No intervention - Psoriasis Subject
Not currently treated plaque psoriasis patients
Control
Subjects who do not have psoriasis.
Other: No intervention - Control Subject
Control subjects without plaque psoriasis and no family history of psoriasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abnormal P63 signaling levels
Time Frame: Day 0
Determining if untreated psoriasis skin has abnormal p63 signaling
Day 0

Collaborators and Investigators

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

Sponsor

Wright State University

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 (Actual)

December 3, 2020

Primary Completion (Actual)

April 14, 2023

Study Completion (Actual)

April 14, 2023

Study Registration Dates

First Submitted

September 17, 2020

First Submitted That Met QC Criteria

September 17, 2020

First Posted (Actual)

September 23, 2020

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06956

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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