Levels of Pigment Epithelium-derived Factor in Patients W... | NCT05252741

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

NCT05252741

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Apr 6, 2022Actual

Enrollment

52Estimated

Phase

Not Applicable

Conditions

Psoriasis

Interventions

serum samples and punch skin biopsies

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2022Actual

Primary Completion Date

Feb 2023Estimated

Completion Date

Sep 2023Estimated

First Submitted Date

Feb 13, 2022

First Submission Date that Met QC Criteria

Feb 22, 2022

First Posted Date

Feb 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2022

Last Update Posted Date

Apr 6, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Omnia Ahmed Abdelhafez, Resident of Dermatology, Venereology and Andrology Sohag General Hospital, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
serum samples and punch skin biopsies	Other	we will take serum samples from psoriasis patients and healthy controls and skin punch biopsies from lesional and non-lesional areas in psoriasis patients.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Omnia Ahmed, Resident of Dermatology	Contact	01064292851		omnia.mohamed1@med.sohag.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine Sohag University	Recruiting	Sohag			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Dec 16, 2024
Reset	Jan 31, 2025

Submission Tracking

Estimated Results First Submitted Date

Dec 16, 2024

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Dec 16, 2024			Jan 31, 2025

Condition Browse Module

MeSH Terms

ID	Term
D011565	Psoriasis

Ancestor Terms

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided