T Central Memory Cells in Early Localized Non-Segmental Vitiligo

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05706636

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Vitiligo	Drug: oral mini pulse Drug: Topical cream Device: targeted phototherapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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: oral mini pulse 5mg / week oral dexamethasone Drug: Topical cream topical fluticasone cream for body lesions and topical tacrolimus for face lesions Device: targeted phototherapy twice weekly targeted excimer light sessions

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: oral mini pulse

5mg / week oral dexamethasone

Drug: Topical cream

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

Device: targeted phototherapy

twice weekly targeted excimer light sessions

Outcome Measures

Primary Outcome Measures

comparing level of circulating central memory T cells (TCM) in early localized vitiligo cases to healthy controls [6 months]
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 [6 months]
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 [6 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo university hospitals, dermatology outpatient clinic	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Study Chair: Samia Esmat, MD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rania Mogawer, principal investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT05706636

Other Study ID Numbers:

V-1-23

First Posted:

Jan 31, 2023

Last Update Posted:

Feb 2, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rania Mogawer, principal investigator, Cairo University

early localized vitiligo

Additional relevant MeSH terms:

Vitiligo

Study Results

No Results Posted as of Feb 2, 2023