Back to resultsLevels of Pigment Epithelium-derived Factor in Patients With Psoriasis.
Primary Purpose
Psoriasis
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
serum samples and punch skin biopsies
Sponsored by
About this trial
This is an interventional screening trial for Psoriasis
Eligibility Criteria
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.
Sites / Locations
- Faculty of Medicine Sohag UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group 1: patients with psoriasis
Group 2: age-, sex-, BMI-, and weight-matched control subjects.
Arm Description
Outcomes
Primary Outcome Measures
changes in serum and tissue levels of (PEDF) in patients with psoriasis
evaluate serum and tissue level of (PEDF) in patients with psoriasis.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05252741
Brief Title
Levels of Pigment Epithelium-derived Factor in Patients With Psoriasis.
Official Title
Evaluation Of Levels Of Pigment Epithelium-Derived Factor (PEDF) In Patients With Psoriasis.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2022 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: patients with psoriasis
Arm Type
Active Comparator
Arm Title
Group 2: age-, sex-, BMI-, and weight-matched control subjects.
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
serum samples and punch skin biopsies
Intervention Description
we will take serum samples from psoriasis patients and healthy controls and skin punch biopsies from lesional and non-lesional areas in psoriasis patients.
Primary Outcome Measure Information:
Title
changes in serum and tissue levels of (PEDF) in patients with psoriasis
Description
evaluate serum and tissue level of (PEDF) in patients with psoriasis.
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omnia Ahmed, Resident of Dermatology
Phone
01064292851
Email
omnia.mohamed1@med.sohag.edu.eg
Facility Information:
Facility Name
Faculty of Medicine Sohag University
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omnia Ahmed, Resident of Dermatology
Phone
01064292851
Email
omnia.mohamed1@med.sohag.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Levels of Pigment Epithelium-derived Factor in Patients With Psoriasis.
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