NCT03371758

Brief Summary

The exact mechanism of impairment of autophagy in vitiligo has not yet been determined.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

1.3 years

First QC Date

December 5, 2017

Last Update Submit

January 19, 2018

Conditions

Autophagy

Outcome Measures

Primary Outcomes (1)

  • Expression of LC3-I, LC3-II & Beclin 1 in vitiligo patients

    1 year

Study Arms (2)

vitiligo patients

EXPERIMENTAL
Other: skin biopsy

healthy controls

EXPERIMENTAL
Other: skin biopsy

Interventions

skin biopsyOTHER

Punch skin biopsy will be taken from the lesional and non-lesional skin of vitiligo patients as well as healthy skin of controls.

healthy controlsvitiligo patients

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with non-segmental vitiligo whether active or stable.
  • Age above 12 years.
  • Both sexes.

You may not qualify if:

  • Patients having other autoimmune disease, heart disease, liver disease, kidney disease, neurological disorder, cancer, active infection or any chronic disease.
  • Pregnancy or breast feeding for female patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maha Fathy Elmasry

Cairo, Egypt

RECRUITING

Study Design

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

Study Record Dates

First Submitted

December 5, 2017

First Posted

December 13, 2017

Study Start

January 1, 2017

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

EG(1)