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.

Официальное название

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.

Обзор

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.

Вмешательства

• Процедура 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
• Препарат 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.
• Устройство Excimer Sessions
  Patients will start Excimer sessions 2 times per week for 4 months after complete healing.

Первичные конечные точки

• Incidence of perilesional halo [Срок оценки: 4 months]
• Percent change in VESTA score [Срок оценки: 4 months]
• Percent change in the surface area of the depigmented patch using point counting technique [Срок оценки: 4 months]

Вторичные конечные точки (4)

• Comparing physician global assessment between two groups [Срок оценки: 4 months]
• Assessing tolerability and safety of oral mini-pulse [Срок оценки: 4 months]
• Assessing change in visual analogue scale [Срок оценки: 4 months]
• Compare VESTA percentage change in different body sites and age groups [Срок оценки: 4 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Dermatology out patient clinic, Faculty of Medicine, Cairo University — Cairo

Идентификаторы

NCT: NCT07472816 · MS-290-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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