Pilot Studies Testing Levels of P63 in Psoriasis Skin Lesions

Completed

• Conditions: Psoriasis
• Interventions: Other: No intervention - Control Subject; Other: No intervention - Psoriasis Subject

• Registration Number: NCT04560647
• Lead Sponsor: Wright State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Study Start: 2020-12-03
• Status Verified: 2023-04
• Primary Completion: 2023-04-14
• Study Completion: 2023-04-14
• Last Update Submitted: 2023-04-18
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	No intervention - Control Subject	Subjects who do not have psoriasis.
Psoriasis	No intervention - Psoriasis Subject	Subjects diagnosed with psoriasis.

Primary Outcome Measures

Name	Time	Method
Abnormal P63 signaling levels	Day 0	Determining if untreated psoriasis skin has abnormal p63 signaling

Trial Locations

Locations (1)

Wright State Physicians; 🇺🇸 Fairborn, Ohio, United States