Objective Evaluation of Intradermal MSC-Derived Exosome Therapy on Facial Skin Quality
August 4, 2026 updated by: Mert Ersan
Objective Analysis of the Effects of Intradermally Administered Mesenchymal Stem Cell-Derived Suspended Exosome Therapy on Facial Skin Quality Using a Standardized Imaging System
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: hilal aybüke yıldız, MD
- Phone Number: +905389675576
- Email: aybuke.yildiz@yeditepe.edu.tr
Study Contact Backup
- Name: mert ersan, associate professor
- Phone Number: +905544565025
- Email: mert.ersan@yeditepe.edu.tr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in composite VISIA absolute score
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in VISIA wrinkle feature count
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA wrinkle absolute score
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA wrinkle percentile ranking
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA skin texture feature count
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA skin texture absolute score
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA skin texture percentile ranking
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA pore feature count
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA pore absolute score
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA pore percentile ranking
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA UV spot feature count
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA UV spot absolute score
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA UV spot percentile ranking
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA brown spot feature count
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA brown spot absolute score
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA brown spot percentile ranking
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA red area feature count
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA red area absolute score
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA red area percentile ranking
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA porphyrin feature count
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA porphyrin absolute score
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA porphyrin percentile ranking
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA spot feature count
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA spot absolute score
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
|
Change in VISIA spot percentile ranking
Time Frame: 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.
|
Baseline to 6 months after the final treatment session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 10, 2026
Primary Completion (Estimated)
November 28, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
March 8, 2026
First Submitted That Met QC Criteria
March 8, 2026
First Posted (Actual)
March 12, 2026
Study Record Updates
Last Update Posted (Actual)
August 7, 2026
Last Update Submitted That Met QC Criteria
August 4, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MSCEXO2026MA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be publicly shared.
Study findings will be reported in aggregated form in scientific publications while maintaining participant confidentiality.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.