Objective Evaluation of Intradermal MSC-Derived Exosome Therapy on Facial Skin Quality

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.

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.

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