Меню
Идёт набор NCT07202156

Ultrasound-Enhanced Delivery of Compound TXA Solution in Melasma

Без фазы С лечением Melasma (Facial Melasma)

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: 10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² in10min, 10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² 10min.
Кому может быть актуально
Состояния в реестре: Melasma (Facial Melasma). Базовые параметры: 20 лет — 55 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

Clinical Trial on the Efficacy and Safety of Ultrasound-Enhanced Delivery of Compound Tranexamic Acid Solution in the Treatment of Melasma

Обзор

Melasma is a localized, acquired hyperpigmentary skin disorder characterized by well-defined, light to dark brown patches. Based on clinical practice and extensive literature reports, tranexamic acid and reduced Glutathione (GSH) are both applied in the treatment of melasma, but their water-soluble nature presents challenges for transdermal absorption. Our preliminary basic and clinical research has demonstrated that ultrasound-assisted delivery significantly enhances the absorption of tranexamic acid and other water-soluble components. Its effect on the skin barrier is temporary and reversible. This study aims to evaluate the efficacy and safety of a compound solution (10% tranexamic acid, 2% GSH) delivered via ultrasound for melasma treatment through a split-face controlled trial.

Вмешательства

  • Устройство 10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² in10min
    5w/cm² Ultrasound-assisted topical application of 10% tranexamic acid and 2% reduced glutathione for 10 mins
  • Другое 10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² 10min
    topical application of 10% tranexamic acid and 2% reduced glutathione for 10 mins

Первичные конечные точки

  • percentage reduction in hemi-MASI [Срок оценки: From enrollment to the end of treatment at 8 weeks, and 4&12 weeks after the final intervention]
Вторичные конечные точки (4)
  • Patient self-assessment [Срок оценки: week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention]
  • Clinical Efficacy [Срок оценки: week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention]
  • VISIA Digital Skin Analysis [Срок оценки: From enrollment to the end of treatment at 8 weeks, and 4&12 weeks after the final intervention]
  • Melasma Quality of Life Scale (MELASQOL) Score [Срок оценки: The enrollment, week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention]

Критерии участия

Критерии включения

-(1) Male or female participants aged 20 to 55 years (inclusive); (2) Subjects clinically diagnosed with melasma and confirmed by the investigator to meet the trial requirements; (3) Subjects willing to comply with follow-up observations and able to provide portrait rights for documentation purposes; (4) Understanding and willingness to participate in the clinical trial, and voluntarily signing a written informed consent form.

Критерии исключения

  • (1) Females who are pregnant, lactating, or planning to become pregnant during the trial period; (2) Subjects with known allergen to tranexamic acid or any excipient in the investigational product; (3) History of thrombosis or other thrombotic tendencies (e.g., hypertension, hyperlipidemia), or inability to discontinue oral contraceptives, estrogen, or prothrombin complex concentrates during the trial; (4) History of visual or ocular abnormalities (e.g. impaired vision, visual field defects, or fundus hemorrhage/edema) caused by abnormal retinal intravascular coagulation; (5) Patients with skin inflammation who have used topical steroid preparations for more than one month; (6) Presence of skin abnormalities at the trial site, such as nevi, ulcers, or erosions; (7) Any acute or chronic medical history (past or present) that may interfere with the validity or safety assessment of the trial; (8) Clinically significant abnormal laboratory test results prior to the trial; (9) Participation in any other clinical trial within 30 days prior to screening; (10) Any other condition deemed by the investigator to be unsuitable for participation in the study.

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

Китай · 1 центр
  • The first Affiliated hospital with Nanjing medical university — Нанкин

Идентификаторы

NCT: NCT07202156 · SR-820

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗