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.

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Procedure: Non-cultured epidermal cell suspension (NCES) surgery; Drug: Oral mini pulse; Device: Excimer Sessions

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Dermatology out patient clinic, Faculty of Medicine, Cairo University
    • Contact: Lobna Alieldin, Lecturer of Dermatology; Phone Number: +201002279968; Email: Lobnaalieldin@cu.edu.eg
    • Principal Investigator: Samia Esmat, Professor of Dermatology
    • Sub-Investigator: Rania Mogawer, Associate professor of Dermato
    • Sub-Investigator: Lobna Alieldin, Lecturer of Dermatology
    • Sub-Investigator: Shrouq El-Essawy, Resident of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-cultured epidermal cell suspension surgery with Mini-Oral Pulse Steroid Therapy; Participants will receive low-dose oral mini-pulse dexamethasone (5 mg/week given on two consecutive days) for 4 weeks before and 4 weeks after undergoing non-cultured epidermal cell suspension (NCES) surgery for stable vitiligo lesions. After healing, participants will receive excimer laser sessions twice weekly and will be followed for 4 months to assess repigmentation, development of perilesional halo, and treatment safety.	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, and the suspension will be centrifuged at 1000g for 5-10 minutes, and the supernatant will be discarded.; 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.
Other: Non-cultured epidermal cell suspension Surgery Alone; Participants will undergo non-cultured epidermal cell suspension (NCES) surgery for stable vitiligo lesions without oral mini-pulse steroid therapy. After healing, participants will receive excimer laser sessions twice weekly and will be followed for 4 months to evaluate repigmentation outcomes and development of perilesional halo.	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, and the suspension will be centrifuged at 1000g for 5-10 minutes, and the supernatant will be discarded.; Device: Excimer Sessions; Patients will start Excimer sessions 2 times per week for 4 months after complete healing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of perilesional halo	• Comparing the incidence of perilesional halo after 4 months of treatment with NCES with and without OMP.	4 months
Percent change in VESTA score	Comparing percent change in pigmentation as per VESTA score with and without OMP.	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	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing physician global assessment between two groups	Comparing physician global assessment after 4 months of treatment with NCES with and without OMP.	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.	4 months
Assessing change in visual analogue scale	Assessing patient satisfaction with and without OMP using change in visual analogue scale.	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.	4 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Vitiligo; non-cultured epidermal cell suspension; Segmental; non-acral; Mini-oral pulse steroid; peri-lesional halo
• Additional Relevant MeSH Terms: Skin Diseases; Hypopigmentation; Pigmentation Disorders; Skin and Connective Tissue Diseases; Vitiligo; Surgical Procedures, Operative
• Other Study ID Numbers: MS-290-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available from the corresponding author upon justified request
• IPD Sharing Time Frame: 3 months up to 12 months after publication.
• IPD Sharing Access Criteria: Researches who provide a methodologically sound proposal to access data to achieve aims in the approved proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No