Objective Evaluation of Intradermal MSC-Derived Exosome Therapy on Facial Skin Quality
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMert Ersan
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
• 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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Mesenchymal Stem Cell-Derived Exosome
Biological/VaccineIntradermal 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Exosome TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to 6 months after the final treatment sessionSecondary outcomes
1
Change in VISIA wrinkle feature count
Evaluation of changes in VISIA wrinkle feature count between baseline and the final follow-up assessment.
Time frame
Baseline to 6 months after the final treatment session2
Change in VISIA wrinkle absolute score
Evaluation of changes in VISIA wrinkle absolute score between baseline and the final follow-up assessment.
Time frame
Baseline to 6 months after the final treatment session3
Change in VISIA wrinkle percentile ranking
Evaluation of changes in VISIA wrinkle percentile ranking between baseline and the final follow-up assessment.
Time frame
Baseline to 6 months after the final treatment session4
Change in VISIA skin texture feature count
Evaluation of changes in VISIA skin texture feature count between baseline and the final follow-up assessment.
Time frame
Baseline to 6 months after the final treatment sessionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Mert Ersan
Lead sponsor
Yeditepe University Hospital
Sponsor institution
Source ClinicalTrials.gov
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