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

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05252741
Collaborator
(none)
52
Enrollment
1
Location
2
Arms
18.3
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: serum samples and punch skin biopsies
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Screening
Official Title:
Evaluation Of Levels Of Pigment Epithelium-Derived Factor (PEDF) In Patients With Psoriasis.
Actual Study Start Date :
Feb 20, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. changes in serum and tissue levels of (PEDF) in patients with psoriasis [12 months]

    evaluate serum and tissue level of (PEDF) in patients with psoriasis.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine Sohag University Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Omnia Ahmed Abdelhafez, Resident of Dermatology, Venereology and Andrology Sohag General Hospital, Sohag University
ClinicalTrials.gov Identifier:
NCT05252741
Other Study ID Numbers:
  • soh-Med-22-02-04
First Posted:
Feb 23, 2022
Last Update Posted:
Apr 6, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Psoriasis

Study Results

No Results Posted as of Apr 6, 2022