VitiligoNCT05706636
T Central Memory Cells in Early Localized Non-Segmental Vitiligo
A study testing oral mini pulse, Topical cream and targeted phototherapy in people with Vitiligo, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- What is being tested?
- oral mini pulse, Topical cream and targeted phototherapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subjects with vitiligo localized to one anatomical area, of ≤ 6 months' duration
Who cannot join
- Patients who received treatment of any type (topical or systemic) within the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Vitiligo
- Being tested
- oral mini pulse, Topical cream, targeted phototherapy
- Keywords
- early localized vitiligo
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral mini pulseDrug
5mg / week oral dexamethasone
Topical creamDrug
topical fluticasone cream for body lesions and topical tacrolimus for face lesions
targeted phototherapyDevice
twice weekly targeted excimer light sessions
| Study group | Role | What they receive |
|---|---|---|
| Early localized vitiligo on topical treatment | Active comparator | Cases will only receive topical steroids/ calcineurin inhibitors and targeted phototherapy Receives: 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 Receives: Drug: oral mini pulse; Drug: Topical cream; Device: targeted phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Feb 2023
- Primary completion1 Dec 2024
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mogawer, Cairo University
- Investigators
- Samia Esmat, MD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706636
- Sponsor's protocol ID
- V-1-23
- Status last verified
- Apr 2025
- First submitted
- 21 Jan 2023
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants' data that underlie reported results will be shared upon request, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T Central Memory Cells in Early Localized Non-Segmental Vitiligo and the Effect of Treatment
- ClinicalTrials.gov ID
- NCT05706636
- Acronym / sponsor ID
- V-1-23
- Conditions
- Vitiligo
- Keywords
- early localized vitiligo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early localized vitiligo on topical treatment | Active comparator | Drug: Topical cream, Device: targeted phototherapyCases will only receive topical steroids/ calcineurin inhibitors and targeted phototherapy |
| Early localized vitiligo on topical and systemic treatment | Active comparator | Drug: oral mini pulse, Drug: Topical cream, Device: targeted phototherapyCases will receive oral mini-pulse steroids, topical steroids/ calcineurin inhibitors and targeted phototherapy |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Subjects with vitiligo localized to one anatomical area, of ≤ 6 months' duration
Key exclusion criteria (1 listed)
- Patients who received treatment of any type (topical or systemic) within the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral mini pulse5mg / week oral dexamethasone | Drug | Early localized vitiligo on topical and systemic treatment |
| Topical creamtopical fluticasone cream for body lesions and topical tacrolimus for face lesions | Drug | Early localized vitiligo on topical and systemic treatment, Early localized vitiligo on topical treatment |
| targeted phototherapytwice weekly targeted excimer light sessions | Device | Early localized vitiligo on topical and systemic treatment, Early localized vitiligo on topical treatment |
Primary outcome
comparing level of circulating central memory T cells (TCM) in early localized vitiligo cases to healthy controls
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: Yes. Participants' data that underlie reported results will be shared upon request, after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samia Esmat, MD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral mini pulse, Topical cream and targeted phototherapy in people with Vitiligo, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparing level of circulating central memory T cells (TCM) in early localized vitiligo cases to healthy controls (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.