NCT05223738

Brief Summary

This study aims to detect the presence and diversity of Tissue resident memory T cell populations in early and late cases of generalized non-segmental Vitiligo.

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
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

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

December 31, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
Last Updated

February 4, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

January 25, 2022

Last Update Submit

January 25, 2022

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (4)

  • CD8+ immunofluorescence

    Number of Tissue resident Memory cells by positively stained by CD8+ in early and late generalized non segmental vitiligo patients

    6months-1 year

  • CD69+ immunofluorescence

    Number of Tissue resident Memory cells by positively stained by CD8+ in early and late generalized non segmental vitiligo patients

    6months-1 year

  • Double CD8+ and CD69+ immunofluorescence

    Number of Tissue resident Memory cells by double stained by CD8+ \&CD 69+ in early and late generalized non segmental vitiligo patients

    6months-1 year

  • VASI

    Vitiligo Area and Severity index minimum 0 maximum 100, the larger the number the worse the condition

    6months-1 year

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Generalized Non-segmental Vitiligo

You may qualify if:

  • \- Patients with Generalized non-segmental Vitiligo ( lesions in more than one anatomical site ).
  • Both genders.
  • Early group: onset less than or equal 6 months.
  • Late group: onset more than 6 months

You may not qualify if:

  • Localized or Segmental Vitiligo.
  • Age \< 14 years.
  • Pregnant females
  • Patient who received treatment of any type within the last 3 months for the late group.
  • Patients with other skin diseases or immunosuppression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr El Ainy University hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hilal

    Kasr El Ainy University Hospital, Faculty of medicine, Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 25, 2022

First Posted

February 4, 2022

Study Start

December 31, 2020

Primary Completion

March 30, 2021

Study Completion

February 1, 2022

Last Updated

February 4, 2022

Record last verified: 2022-01

Locations

EG(1)