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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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-pulse steroids (low-dose dexamethasone: 5mg/week on 2 successive days per week) for 4 weeks before NCES and for 4 weeks afterward.
Patients will start Excimer sessions 2 times per week for 4 months after complete healing.
Dermatology out patient clinic, Faculty of Medicine, Cairo University
Cairo, Egypt
Incidence of perilesional halo
• Comparing the incidence of perilesional halo after 4 months of treatment with NCES with and without OMP.
Time frame: 4 months
Percent change in VESTA score
Comparing percent change in pigmentation as per VESTA score with and without OMP.
Time frame: 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
Time frame: 4 months
Comparing physician global assessment between two groups
Comparing physician global assessment after 4 months of treatment with NCES with and without OMP.
Time frame: 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.
Time frame: 4 months
Assessing change in visual analogue scale
Assessing patient satisfaction with and without OMP using change in visual analogue scale.
Time frame: 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.
Time frame: 4 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.