Objective Analysis of the Effects of Intradermally Administered Mesenchymal Stem Cell-Derived Suspended Exosome Therapy on Facial Skin Quality Using a Standardized Imaging System
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Change in composite VISIA absolute score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• 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
排除标准
- •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
研究组 & 干预措施
Exosome Treatment
Participants will receive intradermal administration of mesenchymal stem cell-derived suspended exosome preparation 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.
干预措施: Mesenchymal Stem Cell-Derived Exosome (Biological)
结局指标
主要结局
Change in composite VISIA absolute score
时间窗: Baseline to 6 months after the final treatment session
Absolute scores will be obtained for each VISIA skin parameter, including wrinkles, skin texture irregularities, pore size, ultraviolet (UV) spots, red areas, brown spots, and porphyrins. The VISIA system calculates absolute scores based on the size, intensity, and total affected area of the detected features within each parameter. A composite score will be generated by calculating the mean of the absolute scores across all evaluated parameters. Changes in the composite VISIA absolute score between baseline and the six-month follow-up after the final treatment session will be analyzed to assess overall changes in facial skin quality.
次要结局
- Change in VISIA wrinkle feature count(Baseline to 6 months after the final treatment session)
- Change in VISIA wrinkle absolute score(Baseline to 6 months after the final treatment session)
- Change in VISIA wrinkle percentile ranking(Baseline to 6 months after the final treatment session)
- Change in VISIA skin texture feature count(Baseline to 6 months after the final treatment session)
- Change in VISIA skin texture absolute score(Baseline to 6 months after the final treatment session)
- Change in VISIA skin texture percentile ranking(Baseline to 6 months after the final treatment session)
- Change in VISIA pore feature count(Baseline to 6 months after the final treatment session)
- Change in VISIA pore absolute score(Baseline to 6 months after the final treatment session)
- Change in VISIA pore percentile ranking(Baseline to 6 months after the final treatment session)
- Change in VISIA UV spot feature count(Baseline to 6 months after the final treatment session)
- Change in VISIA UV spot absolute score(Baseline to 6 months after the final treatment session)
- Change in VISIA UV spot percentile ranking(Baseline to 6 months after the final treatment session)
- Change in VISIA brown spot feature count(Baseline to 6 months after the final treatment session)
- Change in VISIA brown spot absolute score(Baseline to 6 months after the final treatment session)
- Change in VISIA brown spot percentile ranking(Baseline to 6 months after the final treatment session)
- Change in VISIA red area feature count(Baseline to 6 months after the final treatment session)
- Change in VISIA red area absolute score(Baseline to 6 months after the final treatment session)
- Change in VISIA red area percentile ranking(Baseline to 6 months after the final treatment session)
- Change in VISIA porphyrin feature count(Baseline to 6 months after the final treatment session)
- Change in VISIA porphyrin absolute score(Baseline to 6 months after the final treatment session)
- Change in VISIA porphyrin percentile ranking(Baseline to 6 months after the final treatment session)
- Change in VISIA spot feature count(Baseline to 6 months after the final treatment session)
- Change in VISIA spot absolute score(Baseline to 6 months after the final treatment session)
- Change in VISIA spot percentile ranking(Baseline to 6 months after the final treatment session)
- Change in VISIA wrinkle measurements(Baseline to 6 months after the final treatment session)
- Change in VISIA skin texture measurements(Baseline to 6 months after the final treatment session)
- Change in VISIA pore measurements(Baseline to 6 months after the final treatment session)
- Change in VISIA UV spot measurements(Baseline to 6 months after the final treatment session)
- Change in VISIA brown spot measurements(Baseline to 6 months after the final treatment session)
- Change in VISIA porphyrin measurements(Baseline to 6 months after the final treatment session)
- Change in VISIA spot measurements(Baseline to 6 months after the final treatment session)
- Change in VISIA red area measurements(Baseline to 6 months after the final treatment session)
研究者
Mert Ersan
Assistant Professor
Yeditepe University Hospital