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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.
Sponsor: Cairo University
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.
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.
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-03-15
Completion Date
2026-07-01
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
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, and the suspension will be centrifuged at 1000g for 5-10 minutes, and the supernatant will be discarded.
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.
Excimer Sessions
Patients will start Excimer sessions 2 times per week for 4 months after complete healing.
Locations (1)
Dermatology out patient clinic, Faculty of Medicine, Cairo University
Cairo, Egypt