Levels of Pigment Epithelium-derived Factor in Patients With Psoriasis.

March 27, 2022 updated by: Omnia Ahmed Abdelhafez, Sohag University

Evaluation Of Levels Of Pigment Epithelium-Derived Factor (PEDF) In Patients With Psoriasis.

Psoriasis is an immune-mediated chronic inflammatory skin disease associated with increase interaction of inflammatory mediators like adipokines. Pigment epithelium-derived factor (PEDF) is one of the most abundant adipokines and have anti-angiogenesis effect. There is a study showed that PEDF level is up-regulated in the sera of psoriasis patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with psoriasis and group of age and sex-matched healthy volunteers will be included as a control group.

Exclusion Criteria:

  • Pregnancy.
  • Patients with other inflammatory skin disorders.
  • Patients on antioxidants or anti-inflammatory drugs.
  • Patients on topical or systemic treatment for psoriasis in the last 4 weeks prior to enrollment in the study.
  • Patients on systemic retinoids (Acitretin).
  • Obesity: body mass index (BMI ) > 30.
  • Malignancies e.g squamous cell carcinoma.
  • Viral warts.
  • Diabetes.
  • Hypertension.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: patients with psoriasis
Other: serum samples and punch skin biopsies
we will take serum samples from psoriasis patients and healthy controls and skin punch biopsies from lesional and non-lesional areas in psoriasis patients.
Placebo Comparator: Group 2: age-, sex-, BMI-, and weight-matched control subjects.
Other: serum samples and punch skin biopsies
we will take serum samples from psoriasis patients and healthy controls and skin punch biopsies from lesional and non-lesional areas in psoriasis patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in serum and tissue levels of (PEDF) in patients with psoriasis
Time Frame: 12 months
evaluate serum and tissue level of (PEDF) in patients with psoriasis.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2022

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

February 13, 2022

First Submitted That Met QC Criteria

February 22, 2022

First Posted (Actual)

February 23, 2022

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

March 27, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-Med-22-02-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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