NCT03755830

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

November 28, 2018

Status Verified

November 1, 2018

Enrollment Period

7 months

First QC Date

November 25, 2018

Last Update Submit

November 25, 2018

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Study Arms (2)

vitiligo patients

ACTIVE COMPARATOR

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

Other: Skin biopsy

healthy controls

EXPERIMENTAL

A skin biopsy will be taken from each control subject.

Other: Skin biopsy

Interventions

Skin biopsyOTHER

Two skin biopsies (lesional and non-lesional) will be taken from every patient. Also a skin biopsy will be taken from each control subject.

healthy controlsvitiligo patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 25, 2018

First Posted

November 28, 2018

Study Start

December 1, 2018

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

November 28, 2018

Record last verified: 2018-11