Facial Aging, Skin Aging, Skin Quality
Conditions
Keywords
Exosome Therapy, Mesenchymal Stem Cell Exosomes, Facial Rejuvenation, Skin Imaging, VISIA Skin Analysis, Skin Aging Treatment, Regenerative Dermatology
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALMesenchymal 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.
Sponsors
Mert Ersan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* • 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in composite VISIA absolute score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in VISIA wrinkle feature count | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA wrinkle feature count between baseline and the final follow-up assessment. |
| Change in VISIA wrinkle absolute score | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA wrinkle absolute score between baseline and the final follow-up assessment. |
| Change in VISIA wrinkle percentile ranking | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA wrinkle percentile ranking between baseline and the final follow-up assessment. |
| Change in VISIA skin texture feature count | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA skin texture feature count between baseline and the final follow-up assessment. |
| Change in VISIA skin texture absolute score | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA skin texture absolute score between baseline and the final follow-up assessment. |
| Change in VISIA skin texture percentile ranking | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA skin texture percentile ranking between baseline and the final follow-up assessment. |
| Change in VISIA pore feature count | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA pore feature count between baseline and the final follow-up assessment. |
| Change in VISIA pore absolute score | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA pore absolute score between baseline and the final follow-up assessment. |
| Change in VISIA pore percentile ranking | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA pore percentile ranking between baseline and the final follow-up assessment. |
| Change in VISIA UV spot feature count | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA ultraviolet (UV) spot feature count between baseline and the final follow-up assessment. |
| Change in VISIA UV spot absolute score | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA ultraviolet (UV) spot absolute score between baseline and the final follow-up assessment. |
| Change in VISIA UV spot percentile ranking | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA ultraviolet (UV) spot percentile ranking between baseline and the final follow-up assessment. |
| Change in VISIA brown spot feature count | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA brown spot feature count between baseline and the final follow-up assessment. |
| Change in VISIA brown spot absolute score | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA brown spot absolute score between baseline and the final follow-up assessment. |
| Change in VISIA brown spot percentile ranking | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA brown spot percentile ranking between baseline and the final follow-up assessment. |
| Change in VISIA red area feature count | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA red area feature count between baseline and the final follow-up assessment. |
| Change in VISIA red area absolute score | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA red area absolute score between baseline and the final follow-up assessment. |
| Change in VISIA red area percentile ranking | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA red area percentile ranking between baseline and the final follow-up assessment. |
| Change in VISIA porphyrin feature count | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA porphyrin feature count between baseline and the final follow-up assessment. |
| Change in VISIA porphyrin absolute score | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA porphyrin absolute score between baseline and the final follow-up assessment. |
| Change in VISIA porphyrin percentile ranking | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA porphyrin percentile ranking between baseline and the final follow-up assessment. |
| Change in VISIA spot feature count | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA spot feature count between baseline and the final follow-up assessment. |
| Change in VISIA spot absolute score | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA spot absolute score between baseline and the final follow-up assessment. |
| Change in VISIA spot percentile ranking | Baseline to 6 months after the final treatment session | Evaluation of changes in VISIA spot percentile ranking between baseline and the final follow-up assessment. |
Contacts
CONTACThilal aybüke yıldız, MD
CONTACTmert ersan, associate professor
Outcome results
None listed