Skin AgingPhase 3NCT07466953
Objective Evaluation of Intradermal MSC-Derived Exosome Therapy on Facial Skin Quality
A Phase 3 study testing Mesenchymal Stem Cell-Derived Exosome in people with Skin Aging and Facial Aging, run by Mert Ersan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Aging, Facial Aging, Skin Quality
- What is being tested?
- Mesenchymal Stem Cell-Derived Exosome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2026to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Skin Aging, Facial Aging, Skin Quality
- Being tested
- Mesenchymal Stem Cell-Derived Exosome
- Keywords
- Exosome Therapy, Mesenchymal Stem Cell Exosomes, Facial Rejuvenation, Skin Imaging, VISIA Skin Analysis, Skin Aging Treatment, Regenerative Dermatology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem Cell-Derived ExosomeBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Mesenchymal Stem Cell-Derived Exosome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months after the final treatment session
Secondary outcomes (24)
Change in VISIA wrinkle feature count
Evaluation of changes in VISIA wrinkle feature count between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA wrinkle absolute score
Evaluation of changes in VISIA wrinkle absolute score between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA wrinkle percentile ranking
Evaluation of changes in VISIA wrinkle percentile ranking between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA skin texture feature count
Evaluation of changes in VISIA skin texture feature count between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA skin texture absolute score
Evaluation of changes in VISIA skin texture absolute score between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA skin texture percentile ranking
Evaluation of changes in VISIA skin texture percentile ranking between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA pore feature count
Evaluation of changes in VISIA pore feature count between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA pore absolute score
Evaluation of changes in VISIA pore absolute score between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA pore percentile ranking
Evaluation of changes in VISIA pore percentile ranking between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA UV spot feature count
Evaluation of changes in VISIA ultraviolet (UV) spot feature count between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA UV spot absolute score
Evaluation of changes in VISIA ultraviolet (UV) spot absolute score between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA UV spot percentile ranking
Evaluation of changes in VISIA ultraviolet (UV) spot percentile ranking between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA brown spot feature count
Evaluation of changes in VISIA brown spot feature count between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA brown spot absolute score
Evaluation of changes in VISIA brown spot absolute score between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA brown spot percentile ranking
Evaluation of changes in VISIA brown spot percentile ranking between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA red area feature count
Evaluation of changes in VISIA red area feature count between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA red area absolute score
Evaluation of changes in VISIA red area absolute score between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA red area percentile ranking
Evaluation of changes in VISIA red area percentile ranking between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA porphyrin feature count
Evaluation of changes in VISIA porphyrin feature count between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA porphyrin absolute score
Evaluation of changes in VISIA porphyrin absolute score between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA porphyrin percentile ranking
Evaluation of changes in VISIA porphyrin percentile ranking between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA spot feature count
Evaluation of changes in VISIA spot feature count between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA spot absolute score
Evaluation of changes in VISIA spot absolute score between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Change in VISIA spot percentile ranking
Evaluation of changes in VISIA spot percentile ranking between baseline and the final follow-up assessment.
Measured: Baseline to 6 months after the final treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start10 Jul 2026 (estimated)
- Primary completion28 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mert Ersan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mert Ersan, Yeditepe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466953
- Sponsor's protocol ID
- MSCEXO2026MA
- Status last verified
- Aug 2026
- First submitted
- 8 Mar 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared. Study findings will be reported in aggregated form in scientific publications while maintaining participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Analysis of the Effects of Intradermally Administered Mesenchymal Stem Cell-Derived Suspended Exosome Therapy on Facial Skin Quality Using a Standardized Imaging System
- ClinicalTrials.gov ID
- NCT07466953
- Acronym / sponsor ID
- MSCEXO2026MA
- Conditions
- Skin Aging, Facial Aging, Skin Quality
- Keywords
- Exosome Therapy, Mesenchymal Stem Cell Exosomes, Facial Rejuvenation, Skin Imaging, VISIA Skin Analysis, Skin Aging Treatment, Regenerative Dermatology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mert ErsanUniversity, hospital or other
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 28 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exosome Treatment | Experimental | Biological: Mesenchymal Stem Cell-Derived ExosomeParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Adults aged 18 to 65 years
Key exclusion criteria (8 listed)
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal Stem Cell-Derived ExosomeIntradermal 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. | Biological | Exosome Treatment |
Primary outcome
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.
24 secondary outcomes
Change in VISIA wrinkle feature count
Time frame: 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
Change in VISIA wrinkle percentile ranking
Time frame: 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
Change in VISIA skin texture absolute score
Time frame: 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
Change in VISIA pore feature count
Time frame: 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
Change in VISIA pore percentile ranking
Time frame: 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
Change in VISIA UV spot absolute score
Time frame: 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
Change in VISIA brown spot feature count
Time frame: 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
Change in VISIA brown spot percentile ranking
Time frame: 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
Change in VISIA red area absolute score
Time frame: 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
Change in VISIA porphyrin feature count
Time frame: 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
Change in VISIA porphyrin percentile ranking
Time frame: 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
Change in VISIA spot absolute score
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared. Study findings will be reported in aggregated form in scientific publications while maintaining participant confidentiality.
Related trials for Skin Aging
RecruitingObservational study
Improved Facial Skin Quality and Quality of Life After VYC-12L Treatment in Breast Cancer Survivors
Quality of Life, Breast Neoplasms
Active, not recruiting
Integrated Actionable Aging Assessment for Cancer Patients Pilot
Breast Cancer, Hodgkin Lymphoma
Not yet recruitingObservational study
Clinical Research on Deep-Plane Rejuran S Injection for Improvement in the Apperance of Periorbital Hollowing Using a Cannula Technique
Periorbital Hollowing, Skin Aging
Not yet recruitingObservational study
Clinical Evaluation of Dual-Plane Technique PN-Based Treatment for Horizontal Neck Lines Using DNA Fragment Opmizing Technology Polynucleotide (DOT PN)
Skin Aging, Horizontal Neck Lines
Recruiting
Ultraformer MPT Combined With Fractional CO2 Versus Fractional CO2 Alone for Facial Rejuvenation
Skin Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mesenchymal Stem Cell-Derived Exosome in people with Skin Aging and Facial Aging, run by Mert Ersan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact hilal aybüke yıldız, MD (+905389675576, aybuke.yildiz@yeditepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in composite VISIA absolute score (time frame: Baseline to 6 months after the final treatment session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.