T Central Memory Cells in Early Localized Non-Segmental Vitiligo

T Central Memory Cells in Early Localized Non-Segmental Vitiligo and the Effect of Treatment

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

Study Overview

• Status: Not yet recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Drug: Topical cream; Device: targeted phototherapy; Drug: oral mini pulse

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rania Mogawer, MD; Phone Number: 002 01068165330; Email: raniamogawer@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo university hospitals, dermatology outpatient clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 60 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Early localized vitiligo on topical treatment; Cases will only receive topical steroids/ calcineurin inhibitors and targeted phototherapy	Drug: Topical cream; topical fluticasone cream for body lesions and topical tacrolimus for face lesions; Device: targeted phototherapy; twice weekly targeted excimer light sessions
ACTIVE_COMPARATOR: Early localized vitiligo on topical and systemic treatment; Cases will receive oral mini-pulse steroids, topical steroids/ calcineurin inhibitors and targeted phototherapy	Drug: Topical cream; topical fluticasone cream for body lesions and topical tacrolimus for face lesions; Device: targeted phototherapy; twice weekly targeted excimer light sessions; Drug: oral mini pulse; 5mg / week oral dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
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	6 months
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	6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Samia Esmat, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2023
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): September 1, 2023

Study Registration Dates

• First Submitted: January 21, 2023
• First Submitted That Met QC Criteria: January 21, 2023
• First Posted (ACTUAL): January 31, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: early localized vitiligo
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: V-1-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No