NCT05252741

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

February 20, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

12 months

First QC Date

February 13, 2022

Last Update Submit

March 27, 2022

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • changes in serum and tissue levels of (PEDF) in patients with psoriasis

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

    12 months

Study Arms (2)

Group 1: patients with psoriasis

ACTIVE COMPARATOR
Other: serum samples and punch skin biopsies

Group 2: age-, sex-, BMI-, and weight-matched control subjects.

PLACEBO COMPARATOR
Other: serum samples and punch skin biopsies

Interventions

serum samples and punch skin biopsiesOTHER

we will take serum samples from psoriasis patients and healthy controls and skin punch biopsies from lesional and non-lesional areas in psoriasis patients.

Group 1: patients with psoriasisGroup 2: age-, sex-, BMI-, and weight-matched control subjects.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Sohag University

Sohag, Egypt

RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Omnia Ahmed, Resident of Dermatology

CONTACT

01064292851omnia.mohamed1@med.sohag.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Dermatology, Venereology and Andrology Sohag General Hospital

Study Record Dates

First Submitted

February 13, 2022

First Posted

February 23, 2022

Study Start

February 20, 2022

Primary Completion

February 1, 2023

Study Completion

September 1, 2023

Last Updated

April 6, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

Locations

EG(1)