T Central Memory Cells in Early Localized Non-Segmental Vitiligo

NCT05706636 | Completed DMC

• 1 other identifier: V-1-23
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Vitiligo

Keywords

early localized vitiligo

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Early localized vitiligo on topical treatment

ACTIVE COMPARATOR

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

Drug: Topical cream; Device: targeted phototherapy

Early localized vitiligo on topical and systemic treatment

ACTIVE COMPARATOR

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

Drug: oral mini pulse; Drug: Topical cream; Device: targeted phototherapy

Interventions

oral mini pulse DRUG

5mg / week oral dexamethasone

Early localized vitiligo on topical and systemic treatment

Topical cream DRUG

topical fluticasone cream for body lesions and topical tacrolimus for face lesions

Early localized vitiligo on topical and systemic treatment; Early localized vitiligo on topical treatment

targeted phototherapy DEVICE

twice weekly targeted excimer light sessions

Early localized vitiligo on topical and systemic treatment; Early localized vitiligo on topical treatment

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- Subjects with vitiligo localized to one anatomical area, of ≤ 6 months' duration

You may not qualify if:

• Patients who received treatment of any type (topical or systemic) within the last 3 months

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university hospitals, dermatology outpatient clinic

Cairo, Egypt

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Floderm topical cream

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Samia Esmat, MD

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 21, 2023
• First Posted: January 31, 2023
• Study Start: February 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: April 15, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 12 months after article publication
• Access Criteria: Controlled Access: Researchers who provide a methodologically sound proposal will be allowed to access data to achieve aims in the approved proposal

Locations

EG (1)