Pilot Studies Testing Levels of P63 in Psoriasis Skin Lesions

NCT04560647 | Completed

• 1 other identifier: 06956
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Abnormal P63 signaling levels

  Determining if untreated psoriasis skin has abnormal p63 signaling

  Day 0

Study Arms (2)

Psoriasis

Subjects diagnosed with psoriasis.

Other: No intervention - Psoriasis Subject

Control

Subjects who do not have psoriasis.

Other: No intervention - Control Subject

Interventions

No intervention - Psoriasis Subject OTHER

Not currently treated plaque psoriasis patients

Psoriasis

No intervention - Control Subject OTHER

Control subjects without plaque psoriasis and no family history of psoriasis

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wright State University: lead

Study Sites (1)

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jeffrey B Travers, MD, PhD

  Wright State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 23, 2020
• Study Start: December 3, 2020
• Primary Completion: April 14, 2023
• Study Completion: April 14, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

US (1)