Pilot Studies Testing Levels of P63 in Psoriasis Skin Lesions

Psoriasis Clinical Trial

Official title:

Pilot Studies Testing Levels of P63 in Psoriasis Skin Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04560647
• Other study ID #: 06956
• Status: Completed
• Start date: December 3, 2020
• Est. completion date: April 14, 2023

Study information

• Verified date: April 2023
• Source: Wright State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: April 14, 2023
• Est. primary completion date: April 14, 2023
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Other:
• No intervention - Psoriasis Subject
Not currently treated plaque psoriasis patients
• No intervention - Control Subject
Control subjects without plaque psoriasis and no family history of psoriasis

Locations

Country	Name	City	State
United States	Wright State Physicians	Fairborn	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Wright State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal P63 signaling levels	Determining if untreated psoriasis skin has abnormal p63 signaling	Day 0