Pilot Studies Testing Levels of P63 in Psoriasis Skin Lesions

NCT04560647 — Completed, 9 participants, Wright State University

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Registry	NCT04560647
Status	Completed
Study type	Observational
Enrollment	9 (Actual)
Sponsor	Wright State University (Other)
Conditions	Psoriasis
Interventions	No intervention - Psoriasis Subject, No intervention - Control Subject (Other)
Dates	start 2020-12-03, primary completion 2023-04-14, completion 2023-04-14, first posted 2020-09-23, last updated 2023-04-21
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Psoriasis		Other: No intervention - Psoriasis Subject	Subjects diagnosed with psoriasis.
Control		Other: No intervention - Control Subject	Subjects who do not have psoriasis.

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

+Outcome measures

Primary outcomes

Abnormal P63 signaling levels [Day 0]: Determining if untreated psoriasis skin has abnormal p63 signaling

+Eligibility

Sex: All, ages: 18 Years to 50 Years

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

+Locations (1)

Facility	City	Country	Status
Wright State Physicians	Fairborn, Ohio	United States

+Study documents

Informed Consent Form (PDF, 2022-08-15)

+Investigators

Jeffrey B Travers, MD, PhD, Principal investigator, Wright State University