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Prostaglandin F2-alpha (PGF2α) in Vitiligo

Primary Purpose

Vitiligo

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Skin biopsy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vitiligo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    vitiligo patients

    healthy controls

    Arm Description

    Two skin biopsies (lesional and non-lesional) will be taken from every patient.

    A skin biopsy will be taken from each control subject.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    November 25, 2018
    Last Updated
    November 25, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03755830
    Brief Title
    Prostaglandin F2-alpha (PGF2α) in Vitiligo
    Official Title
    Study of the Cutaneous Expression of Prostaglandin F2-alpha (PGF2α) in Vitiligo Patients: a Case-control Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2018 (Anticipated)
    Primary Completion Date
    July 2019 (Anticipated)
    Study Completion Date
    July 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    study the cutaneous expression of PGF2α in vitiligo patients and compare it with normal control subjects.
    Detailed Description
    Measurement of tissue levels of PGF2α in vitiligo patients and compare them with healthy controls.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitiligo

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    vitiligo patients
    Arm Type
    Active Comparator
    Arm Description
    Two skin biopsies (lesional and non-lesional) will be taken from every patient.
    Arm Title
    healthy controls
    Arm Type
    Experimental
    Arm Description
    A skin biopsy will be taken from each control subject.
    Intervention Type
    Other
    Intervention Name(s)
    Skin biopsy
    Intervention Description
    Two skin biopsies (lesional and non-lesional) will be taken from every patient. Also a skin biopsy will be taken from each control subject.
    Primary Outcome Measure Information:
    Title
    Measurement of tissue levels of PGF2α in vitiligo patients and compare them with healthy controls.
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

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    Prostaglandin F2-alpha (PGF2α) in Vitiligo

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