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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-cultured epidermal cell suspension (NCES) surgery, Oral mini pulse, Excimer Sessions.
- Who it may be relevant to
- Registry conditions: Vitiligo. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Procedure Non-cultured epidermal cell suspension (NCES) 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 - Drug Oral mini pulse
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. - Device Excimer Sessions
Patients will start Excimer sessions 2 times per week for 4 months after complete healing.
Primary outcome measures
- Incidence of perilesional halo [Time frame: 4 months]
- Percent change in VESTA score [Time frame: 4 months]
- Percent change in the surface area of the depigmented patch using point counting technique [Time frame: 4 months]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Dermatology out patient clinic, Faculty of Medicine, Cairo University — Cairo
Identifiers
NCT: NCT07472816 · MS-290-2025