Prostaglandin F2-alpha (PGF2α) in Vitiligo

November 25, 2018 updated by: Maha Fathy Elmasry, Cairo University

Study of the Cutaneous Expression of Prostaglandin F2-alpha (PGF2α) in Vitiligo Patients: a Case-control Study.

study the cutaneous expression of PGF2α in vitiligo patients and compare it with normal control subjects.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Measurement of tissue levels of PGF2α in vitiligo patients and compare them with healthy controls.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with non-segmental vitiligo.
  • Both sexes.
  • Age < 18 years old.
  • New cases or cases not receiving any medications for at least 3 months ago.

Exclusion Criteria:

  • Age: Patients < 18 years.
  • Segmental or universal vitiligo.
  • Pregnant and lactating females.

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: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: vitiligo patients
Two skin biopsies (lesional and non-lesional) will be taken from every patient.
Other: Skin biopsy
Two skin biopsies (lesional and non-lesional) will be taken from every patient. Also a skin biopsy will be taken from each control subject.
EXPERIMENTAL: healthy controls
A skin biopsy will be taken from each control subject.
Other: Skin biopsy
Two skin biopsies (lesional and non-lesional) will be taken from every patient. Also a skin biopsy will be taken from each control subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of tissue levels of PGF2α in vitiligo patients and compare them with healthy controls.
Time Frame: 6 months
Measurement of tissue levels of PGF2α in vitiligo patients and compare them with healthy controls to study and verify the hypothesis of involvement of PGF2α in the pathogenesis of vitiligo.• Skin biopsy for assessment of tissue levels of the PGF2α will be taken from both lesional and non lesional skin of patients of vitiligo and from normal skin of healthy controls. All skin biopsies are from non-sun exposed sites.
6 months

Collaborators and Investigators

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

Sponsor

Cairo 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 (ANTICIPATED)

December 1, 2018

Primary Completion (ANTICIPATED)

July 1, 2019

Study Completion (ANTICIPATED)

July 1, 2019

Study Registration Dates

First Submitted

November 25, 2018

First Submitted That Met QC Criteria

November 25, 2018

First Posted (ACTUAL)

November 28, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 28, 2018

Last Update Submitted That Met QC Criteria

November 25, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dermatology 10

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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