VitiligoPhase 4NCT07472816
The Value of Adding Mini-oral Pulse Steroid Therapy in Preventing Peri-lesional Halo Post Non-cultured Epidermal Cell Suspension (NCES) in Cases With Stable Segmental and Non-acral Vitiligo.
A Phase 4 study testing Non-cultured epidermal cell suspension (NCES) surgery, Oral mini pulse and Excimer Sessions in people with Vitiligo, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if adding mini-oral pulse steroid therapy improves the results of non-cultured epidermal cell suspension (NCES) surgery in patients with stable vitiligo. It will also evaluate the safety of this treatment approach. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- Non-cultured epidermal cell suspension (NCES) surgery, Oral mini pulse and Excimer Sessions
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2026to 1 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with segmental vitiligo lesions that are not responsive to conventional treatment.
- Patients with non-Acral vitiligo lesions that are not responsive to conventional treatment and on sites known to be responsive to surgery, like the face and trunk.
- Stability for ≥ 1 year.
- Age ≥12 years.
- Lack of systemic and topical treatment for at least 3 months prior inclusion in the study.
Who cannot join
- Acral vitiligo.
- Segmental vitiligo lesions that are responsive to conventional treatment.
- Non acral vitiligo lesions on sites that are knowingly not responsive to surgery, like knees and elbows.
- Active vitiligo; new lesions, expansion of old lesions, confetti like lesions, ill-defined edges, hypochromia, depigmentation of previously pigmented areas or koebnerization in < 1 year.
- Age < 12 years.
- Pregnant females.
- Patients with contraindication to systemic steroid like uncontrolled hypertension, diabetes or tuberculosis
- Systemic and topical treatment in the past 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Dermatology out patient clinic, Faculty of Medicine, Cairo University
Cairo, 11562
Lobna Alieldin, Lecturer of Dermatology, +201002279968, Lobnaalieldin@cu.edu.eg
Samia Esmat, Professor of Dermatology
About this study
Official title: The Value of Adding Mini-oral Pulse Steroid Therapy in Preventing Peri-lesional Halo Post Non-cultured Epidermal Cell Suspension (NCES) in Cases With Stable Segmental and Non-acral Vitiligo: An Interventional Prospective Randomized Controlled Trial.
The goal of this clinical trial is to learn if adding mini-oral pulse steroid therapy improves the results of non-cultured epidermal cell suspension (NCES) surgery in patients with stable vitiligo. It will also evaluate the safety of this treatment approach. The main questions it aims to answer are:
- Does adding mini-oral pulse steroid therapy reduce the development of a perilesional halo after NCES surgery?
- Does the addition of steroids improve the degree of repigmentation and overall treatment outcomes in vitiligo lesions?
Read more
Researchers will compare NCES surgery with mini-oral pulse steroids to NCES surgery alone to determine whether the steroid therapy improves surgical outcomes.
Participants will:
- Undergo NCES vitiligo surgery for stable segmental or non-acral vitiligo lesions.
- Be randomly assigned to receive either surgery alone or surgery plus low-dose oral mini-pulse dexamethasone therapy.
- Attend follow-up visits and clinical assessments for approximately 4 months.
- Receive excimer laser sessions twice weekly after healing and have standardized photographs and scoring assessments to evaluate repigmentation.
- Conditions
- Vitiligo
- Being tested
- Non-cultured epidermal cell suspension (NCES) surgery, Oral mini pulse, Excimer Sessions
- Keywords
- non-cultured epidermal cell suspension, Vitiligo, Segmental, non-acral, Mini-oral pulse steroid, peri-lesional halo
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-cultured epidermal cell suspension (NCES) surgeryProcedure or surgery
Under aseptic precautions and local anesthesia, a Thiersch graft with a donor-to-recipient ratio of 1:3 will be harvested from the donor site (usually upper thigh/ buttocks).
The skin graft will be transferred to trypsin-EDTA solution and incubated at 37 °C for 20-30 minutes to separate epidermis from the dermis, and then washed with lactated Ringer. The tissue will be teased gently with sterile forceps to release epidermal cells from the trypsin-digested graft. The white dermis will be removed, and the suspension will be centrifuged at 1000g for 5-10 minutes, and the supernatant will be discarded.
Oral mini pulseDrug
Oral mini-pulse steroids (low-dose dexamethasone: 5mg/week on 2 successive days per week) for 4 weeks before NCES and for 4 weeks afterward.
Excimer SessionsDevice
Patients will start Excimer sessions 2 times per week for 4 months after complete healing.
| Study group | Role | What they receive |
|---|---|---|
| Non-cultured epidermal cell suspension surgery with Mini-Oral Pulse Steroid Therapy | Active comparator | Participants will receive low-dose oral mini-pulse dexamethasone (5 mg/week given on two consecutive days) for 4 weeks before and 4 weeks after undergoing non-cultured epidermal cell suspension (NCES) surgery for stable vitiligo lesions. After healing, participants will receive excimer laser sessions twice weekly and will be followed for 4 months to assess repigmentation, development of perilesional halo, and treatment safety. Receives: Procedure: Non-cultured epidermal cell suspension (NCES) surgery; Drug: Oral mini pulse; Device: Excimer Sessions |
| Non-cultured epidermal cell suspension Surgery Alone | Other | Participants will undergo non-cultured epidermal cell suspension (NCES) surgery for stable vitiligo lesions without oral mini-pulse steroid therapy. After healing, participants will receive excimer laser sessions twice weekly and will be followed for 4 months to evaluate repigmentation outcomes and development of perilesional halo. Receives: Procedure: Non-cultured epidermal cell suspension (NCES) surgery; Device: Excimer Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of perilesional halo
- Comparing the incidence of perilesional halo after 4 months of treatment with NCES with and without OMP.
Measured: 4 months
Percent change in VESTA score
Comparing percent change in pigmentation as per VESTA score with and without OMP.
Measured: 4 months
Percent change in the surface area of the depigmented patch using point counting technique
Comparing percent change in the surface area of the depigmented patch following NCES using point counting technique with and without OMP
Measured: 4 months
Secondary outcomes (4)
Comparing physician global assessment between two groups
Comparing physician global assessment after 4 months of treatment with NCES with and without OMP.
Measured: 4 months
Assessing tolerability and safety of oral mini-pulse
Assessing tolerability and safety of oral mini-pulse therapy along with NCES by assessing rate of infection and delayed healing.
Measured: 4 months
Assessing change in visual analogue scale
Assessing patient satisfaction with and without OMP using change in visual analogue scale.
Measured: 4 months
Compare VESTA percentage change in different body sites and age groups
Assessing response to NCES in different sites of body and different age groups and the duration needed for pigmentation to occur.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lobna Gamal Alieldin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472816
- Sponsor's protocol ID
- MS-290-2025
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available from the corresponding author upon justified request
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Adding Mini-oral Pulse Steroid Therapy in Preventing Peri-lesional Halo Post Non-cultured Epidermal Cell Suspension (NCES) in Cases With Stable Segmental and Non-acral Vitiligo: An Interventional Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07472816
- Acronym / sponsor ID
- MS-290-2025
- Conditions
- Vitiligo
- Keywords
- non-cultured epidermal cell suspension, Vitiligo, Segmental, non-acral, Mini-oral pulse steroid, peri-lesional halo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 16 Mar 2026 (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.
The goal of this clinical trial is to learn if adding mini-oral pulse steroid therapy improves the results of non-cultured epidermal cell suspension (NCES) surgery in patients with stable vitiligo. It will also evaluate the safety of this treatment approach. The main questions it aims to answer are:
- Does adding mini-oral pulse steroid therapy reduce the development of a perilesional halo after NCES surgery?
- Does the addition of steroids improve the degree of repigmentation and overall treatment outcomes in vitiligo lesions?
Researchers will compare NCES surgery with mini-oral pulse steroids to NCES surgery alone to determine whether the steroid therapy improves surgical outcomes.
Participants will:
- Undergo NCES vitiligo surgery for stable segmental or non-acral vitiligo lesions.
- Be randomly assigned to receive either surgery alone or surgery plus low-dose oral mini-pulse dexamethasone therapy.
- Attend follow-up visits and clinical assessments for approximately 4 months.
- Receive excimer laser sessions twice weekly after healing and have standardized photographs and scoring assessments to evaluate repigmentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-cultured epidermal cell suspension surgery with Mini-Oral Pulse Steroid Therapy | Active comparator | Procedure: Non-cultured epidermal cell suspension (NCES) surgery, Drug: Oral mini pulse, Device: Excimer SessionsParticipants will receive low-dose oral mini-pulse dexamethasone (5 mg/week given on two consecutive days) for 4 weeks before and 4 weeks after undergoing non-cultured epidermal cell suspension (NCES) surgery for stable vitiligo lesions. After healing, participants will receive excimer laser sessions twice weekly and will be followed for 4 months to assess repigmentation, development of perilesional halo, and treatment safety. |
| Non-cultured epidermal cell suspension Surgery Alone | Other | Procedure: Non-cultured epidermal cell suspension (NCES) surgery, Device: Excimer SessionsParticipants will undergo non-cultured epidermal cell suspension (NCES) surgery for stable vitiligo lesions without oral mini-pulse steroid therapy. After healing, participants will receive excimer laser sessions twice weekly and will be followed for 4 months to evaluate repigmentation outcomes and development of perilesional halo. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with segmental vitiligo lesions that are not responsive to conventional treatment.
- Patients with non-Acral vitiligo lesions that are not responsive to conventional treatment and on sites known to be responsive to surgery, like the face and trunk.
- Stability for ≥ 1 year.
- Age ≥12 years.
- Lack of systemic and topical treatment for at least 3 months prior inclusion in the study.
Key exclusion criteria (8 listed)
- Acral vitiligo.
- Segmental vitiligo lesions that are responsive to conventional treatment.
- Non acral vitiligo lesions on sites that are knowingly not responsive to surgery, like knees and elbows.
- Active vitiligo; new lesions, expansion of old lesions, confetti like lesions, ill-defined edges, hypochromia, depigmentation of previously pigmented areas or koebnerization in < 1 year.
- Age < 12 years.
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 |
|---|---|---|
| Non-cultured epidermal cell suspension (NCES) surgeryUnder aseptic precautions and local anesthesia, a Thiersch graft with a donor-to-recipient ratio of 1:3 will be harvested from the donor site (usually upper thigh/ buttocks). The skin graft will be transferred to trypsin-EDTA solution and incubated at 37 °C for 20-30 minutes to separate epidermis from the dermis, and then washed with lactated Ringer. The tissue will be teased gently with sterile forceps to release epidermal cells from the trypsin-digested graft. The white dermis will be removed, and the suspension will be centrifuged at 1000g for 5-10 minutes, and the supernatant will be discarded. | Procedure or surgery | Non-cultured epidermal cell suspension Surgery Alone, Non-cultured epidermal cell suspension surgery with Mini-Oral Pulse Steroid Therapy |
| Oral mini pulseOral mini-pulse steroids (low-dose dexamethasone: 5mg/week on 2 successive days per week) for 4 weeks before NCES and for 4 weeks afterward. | Drug | Non-cultured epidermal cell suspension surgery with Mini-Oral Pulse Steroid Therapy |
| Excimer SessionsPatients will start Excimer sessions 2 times per week for 4 months after complete healing. | Device | Non-cultured epidermal cell suspension Surgery Alone, Non-cultured epidermal cell suspension surgery with Mini-Oral Pulse Steroid Therapy |
Primary outcome
Incidence of perilesional halo
Time frame: 4 months
• Comparing the incidence of perilesional halo after 4 months of treatment with NCES with and without OMP.
Percent change in VESTA score
Time frame: 4 months
Comparing percent change in pigmentation as per VESTA score with and without OMP.
Percent change in the surface area of the depigmented patch using point counting technique
Time frame: 4 months
Comparing percent change in the surface area of the depigmented patch following NCES using point counting technique with and without OMP
4 secondary outcomes
Comparing physician global assessment between two groups
Time frame: 4 months
Assessing tolerability and safety of oral mini-pulse
Time frame: 4 months
Assessing change in visual analogue scale
Time frame: 4 months
Compare VESTA percentage change in different body sites and age groups
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Yes. Data will be available from the corresponding author upon justified request
Related trials for Vitiligo
RecruitingPhase 2
A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
Non-Segmental Vitiligo (NSV)
Active, not recruitingPhase 1
A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental Vitiligo
Vitiligo
Active, not recruitingPhase 3
A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2
Stable Nonsegmental Vitiligo, Active Nonsegmental Vitiligo
RecruitingPhase 2
A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo
Non-segmental Vitiligo
RecruitingPhase 1
A Trial to Test the Safety and Efficacy of TEV-53408 in Participants With Vitiligo
Vitiligo
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.
Dermatology out patient clinic, Faculty of Medicine, Cairo University
Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Non-cultured epidermal cell suspension (NCES) surgery, Oral mini pulse and Excimer Sessions 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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 16 Mar 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of perilesional halo (time frame: 4 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 16 Mar 2026.