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NCT04560647 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design

Related Conditions & MeSH terms

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
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