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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.

NCT07472816 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-15
Primary Completion
2026-06-15
Completion
2026-07-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07472816 on ClinicalTrials.gov