NCT03377998

Brief Summary

Expression of Erythroid differentiation regulator 1 (Erdr1) cytokine in vitiligo

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

6 months

First QC Date

December 11, 2017

Last Update Submit

December 14, 2017

Conditions

Erythroid Differentiation Regulator 1 (Erdr1) Cytokine

Outcome Measures

Primary Outcomes (1)

  • Expression of tissue levels of erythroid differentiation regulator 1 (Erdr1) cytokine in patients of vitiligo

    Expression of tissue levels of erythroid differentiation regulator 1 (Erdr1) cytokine in patients of vitiligo and comparing its level in normal subjects

    6 months

Study Arms (2)

vitiligo patients

EXPERIMENTAL

lesional skin biopsy to measure ERDR1 level

Other: skin biopsy

controls

EXPERIMENTAL

normal skin biopsy to measure ERDR1 level

Other: skin biopsy

Interventions

skin biopsyOTHER

Skin biopsy for measuring tissue levels of the Erythroid differentiation regulator 1 (Erdr1) cytokine will be taken from the lesional skin of patients of vitiligo and from normal skin of healthy controls.

controlsvitiligo patients

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Segmental or Universal vitiligo
  • Autoimmune diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Maha Elmasry, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maha Fathy Elmasry, MD

CONTACT

00201222633740mahafathy1214@gmail.com

Study Design

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

Study Record Dates

First Submitted

December 11, 2017

First Posted

December 19, 2017

Study Start

January 1, 2018

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

December 19, 2017

Record last verified: 2017-12