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.
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.
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.
Parallel
Non-cultured epidermal cell suspension (NCES) surgery
Procedure/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.
Oral mini pulse
DrugOral 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 Sessions
DevicePatients will start Excimer sessions 2 times per week for 4 months after complete healing.
Incidence of perilesional halo
• Comparing the incidence of perilesional halo after 4 months of treatment with NCES with and without OMP.
Percent change in VESTA score
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
Comparing percent change in the surface area of the depigmented patch following NCES using point counting technique with and without OMP
Comparing physician global assessment between two groups
Comparing physician global assessment after 4 months of treatment with NCES with and without OMP.
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.
Assessing change in visual analogue scale
Assessing patient satisfaction with and without OMP using change in visual analogue scale.
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.
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