Меню
Идёт набор NCT07437560

Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo

Фаза II С лечением NonSegmental Vitiligo Nonsegmental Vitiligo (Stable)

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: Melanotan II (MT-II), Placebo, Narrowband UV-B (NB-UVB) phototherapy.
Кому может быть актуально
Состояния в реестре: NonSegmental Vitiligo, Nonsegmental Vitiligo (Stable). Базовые параметры: 18 лет — 65 лет · 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Melanotan II (Synthetic Cyclic Melanocortin Receptor Agonist) as an Adjunct to Narrowband UV-B Phototherapy in Adults With Stable Nonsegmental Vitiligo

Обзор

This example interventional study record describes a randomized Phase 2 clinical trial evaluating investigational Melanotan II (MT-II) as an adjunct to standard NB-UVB phototherapy for repigmentation in adults with stable nonsegmental vitiligo.

Подробное описание

Vitiligo is characterized by acquired depigmented macules and patches due to the loss of functional melanocytes. Narrowband UV-B (NB-UVB) phototherapy is a common treatment that can promote repigmentation, but responses may be incomplete and can take months. Melanotan II (MT-II) is a synthetic cyclic melanocortin receptor agonist with activity at melanocortin receptors involved in melanogenesis (pigment production). This example trial evaluates the safety and preliminary efficacy of adding investigational MT-II to standardized NB-UVB phototherapy compared with placebo plus NB-UVB in adults with stable nonsegmental vitiligo. Participants are randomized 1:1 and treated for 24 weeks, with standardized digital photography, clinician-rated scoring, and objective colorimetry performed at prespecified visits. Safety monitoring includes adverse event collection, vital signs, and focused skin examinations (including monitoring of nevi). A follow-up visit occurs 4 weeks after the final dose to assess ongoing safety.

Вмешательства

  • Препарат Melanotan II (MT-II)
    administered per protocol
  • Препарат Placebo
    matched, administered per protocol.
  • Процедура Narrowband UV-B (NB-UVB) phototherapy
    standardized schedule per site protocol

Первичные конечные точки

  • Change from baseline in Vitiligo Area Scoring Index (VASI) total score [Срок оценки: 24 Weeks]
Вторичные конечные точки (1)
  • Proportion of participants achieving [Срок оценки: 24 Weeks]

Критерии участия

Критерии включения

  • Adults aged 18-65 years able to provide informed consent.
  • Clinical diagnosis of nonsegmental vitiligo with stable disease (no new lesions and no lesion expansion) for >=6 months prior to screening.
  • Total body surface area involvement between 3% and 20% (inclusive), with at least two measurable target lesions suitable for standardized photography and colorimetry.
  • Willingness to undergo NB-UVB phototherapy per protocol and to avoid non-study vitiligo treatments during the study.
  • For participants of childbearing potential: agreement to use effective contraception during the study and for a protocol-specified period after the last dose.

Критерии исключения

  • Segmental vitiligo as the predominant type, or rapidly progressive disease within the past 6 months.
  • Use of systemic immunosuppressive therapy, systemic corticosteroids, or JAK inhibitors within 8 weeks prior to screening (time windows may vary by drug/class).
  • Use of topical calcineurin inhibitors or topical corticosteroids on target lesions within 2 weeks prior to baseline.
  • Prior treatment with afamelanotide or melanotan (including Melanotan II) within 6 months prior to baseline.
  • History of melanoma, dysplastic nevus syndrome, or other high-risk skin cancer history requiring close surveillance, as judged by the investigator.
  • Clinically significant uncontrolled hypertension, cardiovascular disease, or any condition that, in the investigator's judgment, increases risk with melanocortin agonist exposure.
  • Pregnant or breastfeeding.
  • Known hypersensitivity to study product components.
  • Participation in another interventional clinical trial within 30 days prior to screening.

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Peking University Shenzhen Hospital — Шэньчжэнь

Идентификаторы

NCT: NCT07437560 · DERM-MTII-201

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗