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NCT Number: NCT07472816

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 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.

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Key information

Conditions

Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dermatology out patient clinic, Faculty of Medicine, Cairo University

Cairo, 11562, Egypt

Location contact

Lobna Alieldin, Lecturer of Dermatology

CONTACT

[email protected]

+201002279968

Lobna Alieldin, Lecturer of Dermatology

SUB_INVESTIGATOR

Rania Mogawer, Associate professor of Dermato

SUB_INVESTIGATOR

Samia Esmat, Professor of Dermatology

PRINCIPAL_INVESTIGATOR

Shrouq El-Essawy, Resident of Dermatology

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Excimer Sessions

Device

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

Primary outcomes

  1. Incidence of perilesional halo

    Time frame: 4 months

    • Comparing the incidence of perilesional halo after 4 months of treatment with NCES with and without OMP.

  2. Percent change in VESTA score

    Time frame: 4 months

    Comparing percent change in pigmentation as per VESTA score with and without OMP.

  3. Percent change in the surface area of the depigmented patch using point counting technique

    Time frame: 4 months

    Comparing percent change in the surface area of the depigmented patch following NCES using point counting technique with and without OMP

Secondary outcomes

  1. Comparing physician global assessment between two groups

    Time frame: 4 months

    Comparing physician global assessment after 4 months of treatment with NCES with and without OMP.

  2. Assessing tolerability and safety of oral mini-pulse

    Time frame: 4 months

    Assessing tolerability and safety of oral mini-pulse therapy along with NCES by assessing rate of infection and delayed healing.

  3. Assessing change in visual analogue scale

    Time frame: 4 months

    Assessing patient satisfaction with and without OMP using change in visual analogue scale.

  4. Compare VESTA percentage change in different body sites and age groups

    Time frame: 4 months

    Assessing response to NCES in different sites of body and different age groups and the duration needed for pigmentation to occur.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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