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.

NCT07472816 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: MS-290-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitiligo

Keywords

non-cultured epidermal cell suspension; Vitiligo; Segmental; non-acral; Mini-oral pulse steroid; peri-lesional halo

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Comparing physician global assessment between two groups

  4 months

• Assessing tolerability and safety of oral mini-pulse

  4 months

• Assessing change in visual analogue scale

  4 months

• Compare VESTA percentage change in different body sites and age groups

  4 months

Study Arms (2)

Non-cultured epidermal cell suspension surgery with Mini-Oral Pulse Steroid Therapy

ACTIVE COMPARATOR

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; Drug: Oral mini pulse; Device: Excimer Sessions

Non-cultured epidermal cell suspension Surgery Alone

OTHER

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; Device: Excimer Sessions

Interventions

Non-cultured epidermal cell suspension (NCES) surgery PROCEDURE

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.

Non-cultured epidermal cell suspension Surgery Alone; Non-cultured epidermal cell suspension surgery with Mini-Oral Pulse Steroid Therapy

Oral mini pulse DRUG

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.

Non-cultured epidermal cell suspension surgery with Mini-Oral Pulse Steroid Therapy

Excimer Sessions DEVICE

Patients will start Excimer sessions 2 times per week for 4 months after complete healing.

Non-cultured epidermal cell suspension Surgery Alone; Non-cultured epidermal cell suspension surgery with Mini-Oral Pulse Steroid Therapy

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Dermatology out patient clinic, Faculty of Medicine, Cairo University

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 16, 2026
• Study Start: March 15, 2026
• Primary Completion: June 15, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 months up to 12 months after publication.
• Access Criteria: Researches who provide a methodologically sound proposal to access data to achieve aims in the approved proposal.

Locations

EG (1)