Pilot Studies Testing Levels of P63 in Psoriasis Skin Lesions

NCT ID: NCT04560647

Last Updated: 2023-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-03

Study Completion Date

2023-04-14

Brief Summary

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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

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Conditions

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Psoriasis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Psoriasis

Subjects diagnosed with psoriasis.

No intervention - Psoriasis Subject

Intervention Type OTHER

Not currently treated plaque psoriasis patients

Control

Subjects who do not have psoriasis.

No intervention - Control Subject

Intervention Type OTHER

Control subjects without plaque psoriasis and no family history of psoriasis

Interventions

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No intervention - Psoriasis Subject

Not currently treated plaque psoriasis patients

Intervention Type OTHER

No intervention - Control Subject

Control subjects without plaque psoriasis and no family history of psoriasis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wright State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey B Travers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wright State University

Locations

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Wright State Physicians

Fairborn, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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06956

Identifier Type: -

Identifier Source: org_study_id

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