Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prostaglandin F2-alpha (PGF2α) in Vitiligo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03755830
Recruitment Status : Not yet recruiting
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Maha Fathy Elmasry, Cairo University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
study the cutaneous expression of PGF2α in vitiligo patients and compare it with normal control subjects.

Condition or disease Intervention/treatment Phase
Vitiligo Other: Skin biopsy Not Applicable

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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of the Cutaneous Expression of Prostaglandin F2-alpha (PGF2α) in Vitiligo Patients: a Case-control Study.
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Vitiligo

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Maha Fathy Elmasry, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03755830     History of Changes
Other Study ID Numbers: Dermatology 10
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Dinoprost
Dinoprost tromethamine
 Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Oxytocics