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Prostaglandin F2-alpha (PGF2α) in Vitiligo

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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

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.

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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

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.




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.



Information from the National Library of Medicine

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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.

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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

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