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This study aims to evaluate the potential effects of mesenchymal stem cell-derived suspended exosome therapy on facial skin quality using objective imaging analysis. Thirty 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.
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. Thirty 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exosome Treatment | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal Stem Cell-Derived Exosome | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in composite VISIA absolute score | 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. | Baseline to 6 months after the final treatment session |
| Measure | Description | Time Frame |
|---|---|---|
| Change in VISIA wrinkle measurements | Evaluation of changes in VISIA wrinkle measurements including feature count, absolute score, and percentile ranking between baseline and the final follow-up assessment. | Baseline to 6 months after the final treatment session |
| Change in VISIA skin texture measurements |
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Inclusion Criteria:
• Adults aged 18 to 65 years
Exclusion Criteria:
Pregnancy or breastfeeding
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hilal aybüke yıldız, MD | Contact | +905389675576 | aybuke.yildiz@yeditepe.edu.tr | |
| mert ersan, associate professor | Contact | +905544565025 | mert.ersan@yeditepe.edu.tr |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39231070 | Background | Wyles SP, Proffer SL, Farris P, Randall L, Hillestad ML, Lupo MP, Behfar A. Effect of Topical Human Platelet Extract (HPE) for Facial Skin Rejuvenation: A Histological Study of Collagen and Elastin. J Drugs Dermatol. 2024 Sep 1;23(9):735-740. doi: 10.36849/JDD.8162. | |
| 35689936 | Background | Proffer SL, Paradise CR, DeGrazia E, Halaas Y, Durairaj KK, Somenek M, Sivly A, Boon AJ, Behfar A, Wyles SP. Efficacy and Tolerability of Topical Platelet Exosomes for Skin Rejuvenation: Six-Week Results. Aesthet Surg J. 2022 Sep 14;42(10):1185-1193. doi: 10.1093/asj/sjac149. |
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Individual participant data will not be publicly shared. Study findings will be reported in aggregated form in scientific publications while maintaining participant confidentiality.
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All participants will receive intradermal mesenchymal stem cell-derived suspended exosome treatment in three sessions administered at one-month intervals. Facial skin analysis will be performed using the VISIA imaging system before each treatment session and six months after the final treatment.
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Assessment of changes in VISIA skin texture measurements including feature count, absolute score, and percentile ranking. |
| Baseline to 6 months after the final treatment session |
| Change in VISIA pore measurements | Evaluation of changes in VISIA pore measurements including feature count, absolute score, and percentile ranking. | Baseline to 6 months after the final treatment session |
| Change in VISIA UV spot measurements | Assessment of changes in ultraviolet (UV) spot measurements obtained from VISIA imaging analysis including feature count, absolute score, and percentile ranking. | Baseline to 6 months after the final treatment session |
| Change in VISIA brown spot measurements | Assessment of changes in VISIA brown spot measurements including feature count, absolute score, and percentile ranking. | Baseline to 6 months after the final treatment session |
| Change in VISIA porphyrin measurements | Evaluation of changes in VISIA porphyrin measurements including feature count, absolute score, and percentile ranking. | Baseline to 6 months after the final treatment session |
| Change in VISIA spot measurements | Assessment of changes in VISIA spot measurements including feature count, absolute score, and percentile ranking. | Baseline to 6 months after the final treatment session |
| Change in VISIA red area measurements | Evaluation of changes in VISIA red area measurements including feature count, absolute score, and percentile ranking. | Baseline to 6 months after the final treatment session |