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Набор скоро начнётся NCT06891924

A Clinical Study on Pre-operative Intervention With Products During Aesthetic Medicine

Без фазы С лечением Skin Aging Skin Condition Skin Manifestations

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: 14-day daily pre-operative application of the formulations containing MLYAAT-1002® before Fotona4D treatment, 14-day daily pre-operative application of the formulations without MLYAAT-1002® before Fotona4D treatment.
Кому может быть актуально
Состояния в реестре: Skin Aging, Skin Condition, Skin Manifestations. Базовые параметры: 35 лет — 60 лет · Женщины.
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

Clinical Study on Pre-operative Intervention With Products to Mitigate Skin Discomfort During Aesthetic Medicine

Обзор

This clinical trial aims to evaluate whether a 14-day pre-operative application of the test product (containing MLYAAT-1002®, a proprietary anti-aging complex) can mitigate skin discomfort during Fotona 4D laser therapy (Frac3 and Piano modes) by comparing clinical evaluation, skin attributes measurement and subject self-assessment.

Вмешательства

  • Комбинированный продукт 14-day daily pre-operative application of the formulations containing MLYAAT-1002® before Fotona4D treatment
    All enrolled subjects will complete a 14-day washout period followed by a 14-day run-in phase prior to Fotona 4D® laser treatment. During the initial washout phase, participants will exclusively use basic skincare products: sunscreen, cleansing foam, and moisturizing emulsion. Then the subjects will apply the formulations containing MLYAAT-1002® of the active comparator to randomly assigned split-face (the treatment side) for the subsequent 14-day period. Following completion of the product appl
  • Комбинированный продукт 14-day daily pre-operative application of the formulations without MLYAAT-1002® before Fotona4D treatment
    All enrolled subjects will complete a 14-day washout period followed by a 14-day run-in phase prior to Fotona 4D® laser treatment. During the initial washout phase, participants will exclusively use basic skincare products: sunscreen, cleansing foam, and moisturizing emulsion. Then the subjects will apply the formulations without MLYAAT-1002® of the placebo comparator to randomly assigned split-face (the control side) for the subsequent 14-day period. Following completion of the product applicat

Первичные конечные точки

  • changes in the percentage of area in the red zone of facial skin [Срок оценки: Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)]
  • Self-assessment of the facial state questionnaire [Срок оценки: Baseline (before Fotona 4D treatment), Timm (immediately after Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)]
Вторичные конечные точки (2)
  • changes in transepidermal water loss (TEWL) of facial skin [Срок оценки: D-14(14 days before Fotona 4D treatment), Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)]
  • changes in skin stratum corneum water content [Срок оценки: D-14(14 days before Fotona 4D treatment), Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)]

Критерии участия

Критерии включения

  • health females aged 35-60;
  • subjects with rough dark, loose fine lines;
  • no history of cosmetic allergies;
  • subjects are willing to use the test serum on split-face for 28 days;
  • subjects are willing to suffer the Fotona 4D treatment (Frac3 and Piano modes) on the face;
  • subjects are willing to use the basic skincare products for 28 days, and acceptable for split-face use of the test products or the control product for 14 days;
  • written informed consent and portrait right consent were obtained from all participants before study entry.

Критерии исключения

  • anyone who is pregnant, nursing an infant, or planning a pregnancy during the study;
  • subjects with known allergies or sensitivities to the ingredients in any of the study products;
  • any symptoms of facial flushing, erythema, papules, desquamation, or edema as evaluated by a physician prior to initial screening or Fotona4D Pro treatment;
  • unhealed skin lesions;
  • participated in any other clinical trial within one month;
  • received facial skin treatments including but not limited to lasers, chemical peels, and dermal fillers within one month;
  • taken/injected anti-allergy medication in the past one month;
  • participants in other clinical trials at the same time;
  • any subjects that the investigator considers ineligible.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06891924 · Botanee-252003

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗