Clincosm LogoSign in Get a demo

Pilot Studies Testing Levels of P63 in Psoriasis Skin Lesions

Sponsor
Wright State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04560647
Collaborator
(none)
40
Enrollment
1
Location
23.9
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention - Psoriasis Subject
  • Other: No intervention - Control Subject

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Pilot Studies Testing Levels of P63 in Psoriasis Skin Lesions
Actual Study Start Date :
Dec 3, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Abnormal P63 signaling levels [Day 0]

    Determining if untreated psoriasis skin has abnormal p63 signaling

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wright State Physicians Fairborn Ohio United States 45324

Sponsors and Collaborators

  • Wright State University

Investigators

  • Principal Investigator: Jeffrey B Travers, MD, PhD, Wright State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wright State University
ClinicalTrials.gov Identifier:
NCT04560647
Other Study ID Numbers:
  • 06956
First Posted:
Sep 23, 2020
Last Update Posted:
Mar 28, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Psoriasis

Study Results

No Results Posted as of Mar 28, 2022