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Набор скоро начнётся NCT06877455

Topical Methotrexate with Fractional CO2 Laser in Treatment of Non Segmental Vitiligo

Без фазы С лечением Vitiligo

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Fractional CO2 laser assisted PDT.
Кому может быть актуально
Состояния в реестре: Vitiligo. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Efficacy of Topical Methotrexate with Fractional CO2 Laser Versus Topical Methotrexate Alone in Treatment of Non Segmental Vitiligo

Обзор

This prospective, within subject clinical trial aims to evaluate the efficacy of combining fractional CO2 laser with topical methotrexate versus topical methotrexate alone in treating non-segmental vitiligo. Patients with comparable lesions on both sides of their body will receive both treatments randomly assigned to each side. The study assesses repigmentation, safety, patient satisfaction, and quality of life over six months.

Подробное описание

The study is a prospective, within subject, self-controlled, randomized clinical trial conducted at the Department of Dermatology, Assiut University. Participants are patients aged 18-65 with stable non-segmental vitiligo, having comparable lesions on both sides of their body. They must not have received corticosteroid or phototherapy treatments in the last three months and must provide informed consent. Exclusion criteria include other skin diseases, pregnancy, severe organ dysfunction, compromised immune function, and skin type 1 with phototherapy allergy.

Intervention and Follow-Up One side of each participant's body will receive fractional CO2 laser combined with methotrexate 1% gel, while the other side will receive topical methotrexate alone, with treatments randomized to avoid bias. The laser therapy consists of four sessions at three-week intervals using specific parameters. Participants will be followed up for six months, with assessments at baseline, during treatment, and post-treatment.

Outcome Measures The primary outcome is the percentage of repigmentation, assessed through standardized digital photographs evaluated by blinded dermatologists. Secondary outcomes include safety evaluation, patient satisfaction, the pattern of repigmentation, the Vitiligo Area Scoring Index (VASI) score, and quality of life measured using a validated questionnaire.

Methods for Evaluation Photographs will be taken under Wood's lamp examination at baseline, before each treatment session, and two months after the final treatment. The efficacy will be evaluated by comparing pre- and post-treatment photographs. Safety and patient satisfaction will be assessed throughout the study period. The study aims to provide evidence on the effectiveness of combining fractional CO2 laser with topical methotrexate for vitiligo treatment.

Вмешательства

  • Процедура Fractional CO2 laser assisted PDT
    One side of the body will receive fractional CO2 laser combined with methotrexate 1% gel , while the other side will receive topical methotrexate alone (or vice versa, randomized to avoid bias) for 3 months. Laser therapy will be performed as 4 sessions of 3 weeks interval using fractional ablative CO2 10,600 nm laser device (Daeshin Enterprise Co., Ltd. Model: Multixel, Seoul, Korea). A single pass will be performed at the following parameters: pulse energy 42-45 mJ, density of 100 spots/cm2 d

Первичные конечные точки

  • percentage of repigmentation [Срок оценки: 6months]

Критерии участия

Критерии включения

  • Participants are patients aged 18-65 with stable non-segmental vitiligo, having comparable lesions on both sides of their body. They must not have received corticosteroid or phototherapy treatments in the last three months and must provide informed consent.

Критерии исключения

  • Exclusion criteria include other skin diseases, pregnancy, severe organ dysfunction, compro

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Abdelmaksoud A, Dave DD, Lotti T, Vestita M. Topical methotrexate 1% gel for treatment of vitiligo: A case report and review of the literature. Dermatol Ther. 2019 Sep;32(5):e13013. doi: 10.1111/dth.13013. Epub 2019 Jul 16. PMID 31265164

Идентификаторы

NCT: NCT06877455 · fractional laser for vitiligo

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗