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T Central Memory Cells in Early Localized Non-Segmental Vitiligo

Primary Purpose

Vitiligo

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
oral mini pulse
Topical cream
targeted phototherapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring early localized vitiligo

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: - Subjects with vitiligo localized to one anatomical area, of ≤ 6 months' duration Exclusion Criteria: Patients who received treatment of any type (topical or systemic) within the last 3 months

Sites / Locations

  • Cairo university hospitals, dermatology outpatient clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Early localized vitiligo on topical treatment

Early localized vitiligo on topical and systemic treatment

Arm Description

Cases will only receive topical steroids/ calcineurin inhibitors and targeted phototherapy

Cases will receive oral mini-pulse steroids, topical steroids/ calcineurin inhibitors and targeted phototherapy

Outcomes

Primary Outcome Measures

comparing level of circulating central memory T cells (TCM) in early localized vitiligo cases to healthy controls
comparing TCM levels in early localized vitiligo cases prior to and after treatment to healthy controls
percent change in the level of circulating central memory T cells (TCM) in early localized vitiligo cases after treatment
assessing the level of circulating central memory T cells (TCM) in early localized vitiligo cases after treatment and calculating percent change in their levels
comparing percent change in the level of circulating central memory T cells (TCM) in early localized vitiligo cases after treatment in those receiving systemic treatment to those receiving only topical treatment
assessing the level of circulating central memory T cells (TCM) in early localized vitiligo cases after treatment and calculating percent change in their levels in those receiving systemic treatment to those receiving only topical treatment

Secondary Outcome Measures

Full Information

First Posted
January 21, 2023
Last Updated
January 31, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05706636
Brief Title
T Central Memory Cells in Early Localized Non-Segmental Vitiligo
Official Title
T Central Memory Cells in Early Localized Non-Segmental Vitiligo and the Effect of Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Assessing the level of circulating TCMs (cluster of differentiation (CD) 8+, CD3+,C- chemokine receptor (CCR)7, cluster of differentiation 45 receptor (CD45R) cells) in early localized vitiligo cases prior to treatment and after treatment in comparison to healthy controls. This, in turn, would provide insights regarding the role of TCMs in vitiligo and the role of early treatment in halting disease progression and autoimmune memory formation that accounts for high recurrence rate of vitiligo
Detailed Description
Assessing the level of circulating TCMs (CD8+ CD3+ CCR7+ CD45RO+ cells) in early localized vitiligo cases where samples will be processed and stained for CD8, CD3, CCR7, . CCR7, CD45R. Multi-parametric flow cytometry will be used to quantify CD3+ve, CD8+ve, CCR7+ve, CD45RO+ve TCM cells percentage, which will be expressed as a percentage from the total lymphocyte gate. This will be done prior to treatment and after treatment and will be compared to healthy controls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
early localized vitiligo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early localized vitiligo on topical treatment
Arm Type
Active Comparator
Arm Description
Cases will only receive topical steroids/ calcineurin inhibitors and targeted phototherapy
Arm Title
Early localized vitiligo on topical and systemic treatment
Arm Type
Active Comparator
Arm Description
Cases will receive oral mini-pulse steroids, topical steroids/ calcineurin inhibitors and targeted phototherapy
Intervention Type
Drug
Intervention Name(s)
oral mini pulse
Intervention Description
5mg / week oral dexamethasone
Intervention Type
Drug
Intervention Name(s)
Topical cream
Intervention Description
topical fluticasone cream for body lesions and topical tacrolimus for face lesions
Intervention Type
Device
Intervention Name(s)
targeted phototherapy
Intervention Description
twice weekly targeted excimer light sessions
Primary Outcome Measure Information:
Title
comparing level of circulating central memory T cells (TCM) in early localized vitiligo cases to healthy controls
Description
comparing TCM levels in early localized vitiligo cases prior to and after treatment to healthy controls
Time Frame
6 months
Title
percent change in the level of circulating central memory T cells (TCM) in early localized vitiligo cases after treatment
Description
assessing the level of circulating central memory T cells (TCM) in early localized vitiligo cases after treatment and calculating percent change in their levels
Time Frame
6 months
Title
comparing percent change in the level of circulating central memory T cells (TCM) in early localized vitiligo cases after treatment in those receiving systemic treatment to those receiving only topical treatment
Description
assessing the level of circulating central memory T cells (TCM) in early localized vitiligo cases after treatment and calculating percent change in their levels in those receiving systemic treatment to those receiving only topical treatment
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Subjects with vitiligo localized to one anatomical area, of ≤ 6 months' duration Exclusion Criteria: Patients who received treatment of any type (topical or systemic) within the last 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rania Mogawer, MD
Phone
01068165330
Ext
002
Email
raniamogawer@kasralainy.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samia Esmat, MD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Cairo university hospitals, dermatology outpatient clinic
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Participants' data that underlie reported results will be shared upon request, after deidentification
IPD Sharing Time Frame
Beginning 3 months and ending 12 months after article publication
IPD Sharing Access Criteria
Controlled Access: Researchers who provide a methodologically sound proposal will be allowed to access data to achieve aims in the approved proposal

Learn more about this trial

T Central Memory Cells in Early Localized Non-Segmental Vitiligo

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