The Value of Adding Mini-oral Pulse Steroid Therapy in Preventing Peri-lesional Halo Post Non-cul… (NCT07472816) | Clinical Trial Compass
Not Yet RecruitingPhase 4
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.
Egypt60 participantsStarted 2026-03-15
Plain-language 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. 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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* 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.
Exclusion criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of perilesional halo
Timeframe: 4 months
2
Percent change in VESTA score
Timeframe: 4 months
3
Percent change in the surface area of the depigmented patch using point counting technique