Objective Evaluation of Intradermal MSC-Derived Exosome Therapy on Facial Skin Quality
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: Mesenchymal Stem Cell-Derived Exosome.
- Кому может быть актуально
- Состояния в реестре: Skin Aging, Facial Aging, Skin Quality. 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
- 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
Objective Analysis of the Effects of Intradermally Administered Mesenchymal Stem Cell-Derived Suspended Exosome Therapy on Facial Skin Quality Using a Standardized Imaging System
Обзор
This study aims to evaluate the potential effects of mesenchymal stem cell-derived suspended exosome therapy on facial skin quality using objective imaging analysis. Forty adult participants will receive intradermal exosome applications in three treatment sessions performed at one-month intervals. Facial skin analysis will be conducted using the VISIA imaging system before each treatment session and six months after the final treatment. The study will examine changes in multiple facial skin characteristics including wrinkles, pigmentation, skin texture, pores, UV spots, red areas, brown spots, and porphyrins to determine whether exosome therapy may improve overall facial skin quality.
Подробное описание
This single-center prospective interventional clinical study is designed to objectively evaluate changes in facial skin characteristics following intradermal administration of mesenchymal stem cell-derived suspended exosome preparation. Forty adult participants will be enrolled. Each participant will receive three intradermal treatment sessions administered at one-month intervals. Facial skin analysis will be performed using the VISIA digital imaging system at baseline, prior to each treatment session, and six months after the final treatment session.
The VISIA system performs standardized digital analysis of facial skin by quantifying several dermatologic parameters, including wrinkles, skin texture irregularities, pore size, ultraviolet (UV) spots, red areas, brown spots, and porphyrins. The system evaluates these parameters using three complementary quantitative measurement methods. Feature count represents the total number of detected skin features within each parameter category. Absolute score reflects the size, intensity, and total affected area of each detected feature, providing a quantitative measure of severity. Percentile ranking compares each participant's measurements with a reference population matched for age and skin type, allowing evaluation of the relative position of the participant's skin condition within the reference database.
Changes in VISIA-derived measurements between baseline and follow-up assessments will be analyzed to determine the potential effects of intradermal exosome therapy on facial skin quality. The primary outcome measure will focus on changes in composite VISIA absolute scores between baseline and the final follow-up assessment. Secondary analyses will evaluate changes in individual VISIA parameters including wrinkles, pigmentation-related features, skin texture, pore size, UV spots, red areas, brown spots, and porphyrins.
Вмешательства
- Биопрепарат Mesenchymal Stem Cell-Derived Exosome
Intradermal administration of mesenchymal stem cell-derived suspended exosome preparation (5 cc per session) applied to the facial skin in three treatment sessions performed at one-month intervals.
Первичные конечные точки
- Change in composite VISIA absolute score [Срок оценки: Baseline to 6 months after the final treatment session]
Вторичные конечные точки (12)
- Change in VISIA wrinkle feature count [Срок оценки: Baseline to 6 months after the final treatment session]
- Change in VISIA wrinkle absolute score [Срок оценки: Baseline to 6 months after the final treatment session]
- Change in VISIA wrinkle percentile ranking [Срок оценки: Baseline to 6 months after the final treatment session]
- Change in VISIA skin texture feature count [Срок оценки: Baseline to 6 months after the final treatment session]
- Change in VISIA skin texture absolute score [Срок оценки: Baseline to 6 months after the final treatment session]
- Change in VISIA skin texture percentile ranking [Срок оценки: Baseline to 6 months after the final treatment session]
- Change in VISIA pore feature count [Срок оценки: Baseline to 6 months after the final treatment session]
- Change in VISIA pore absolute score [Срок оценки: Baseline to 6 months after the final treatment session]
- Change in VISIA pore percentile ranking [Срок оценки: Baseline to 6 months after the final treatment session]
- Change in VISIA UV spot feature count [Срок оценки: Baseline to 6 months after the final treatment session]
- Change in VISIA UV spot absolute score [Срок оценки: Baseline to 6 months after the final treatment session]
- Change in VISIA UV spot percentile ranking [Срок оценки: Baseline to 6 months after the final treatment session]
Критерии участия
Критерии включения
- • Adults aged 18 to 65 years
- Individuals presenting facial skin aging signs
- Willingness to undergo three intradermal treatment sessions
- Ability to comply with study visits and follow-up assessments
- Ability to understand the study procedures and provide written informed consent
Критерии исключения
- Pregnancy or breastfeeding
- Active skin infection, inflammatory skin disease, or open wounds in the treatment area
- History of allergic reactions to injectable dermatologic treatments
- Use of systemic or topical retinoids within the past 6 months
- Receipt of facial cosmetic procedures (laser treatment, fillers, botulinum toxin, PRP, or similar treatments) within the past 6 months
- Presence of autoimmune disease or immunosuppressive conditions
- Active malignancy or ongoing cancer treatment
- Participation in another clinical study within the past 3 months
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07466953 · MSCEXO2026MA