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

March 8, 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. Thirty 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. Thirty 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)

30

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

Study Contact Backup

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.
Biological: Mesenchymal 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.

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 measurements
Time Frame: Baseline to 6 months after the final treatment session
Evaluation of changes in VISIA wrinkle measurements including feature count, absolute score, and percentile ranking between baseline and the final follow-up assessment.
Baseline to 6 months after the final treatment session
Change in VISIA skin texture measurements
Time Frame: Baseline to 6 months after the final treatment session
Assessment of changes in VISIA skin texture measurements including feature count, absolute score, and percentile ranking.
Baseline to 6 months after the final treatment session
Change in VISIA pore measurements
Time Frame: Baseline to 6 months after the final treatment session
Evaluation of changes in VISIA pore measurements including feature count, absolute score, and percentile ranking.
Baseline to 6 months after the final treatment session
Change in VISIA UV spot measurements
Time Frame: Baseline to 6 months after the final treatment session
Assessment of changes in ultraviolet (UV) spot measurements obtained from VISIA imaging analysis including feature count, absolute score, and percentile ranking.
Baseline to 6 months after the final treatment session
Change in VISIA brown spot measurements
Time Frame: Baseline to 6 months after the final treatment session
Assessment of changes in VISIA brown spot measurements including feature count, absolute score, and percentile ranking.
Baseline to 6 months after the final treatment session
Change in VISIA porphyrin measurements
Time Frame: Baseline to 6 months after the final treatment session
Evaluation of changes in VISIA porphyrin measurements including feature count, absolute score, and percentile ranking.
Baseline to 6 months after the final treatment session
Change in VISIA spot measurements
Time Frame: Baseline to 6 months after the final treatment session
Assessment of changes in VISIA spot measurements including feature count, absolute score, and percentile ranking.
Baseline to 6 months after the final treatment session
Change in VISIA red area measurements
Time Frame: Baseline to 6 months after the final treatment session
Evaluation of changes in VISIA red area measurements including feature count, absolute score, and percentile ranking.
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

Mert Ersan

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

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)

April 1, 2026

Primary Completion (Estimated)

December 1, 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)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 8, 2026

Last Verified

March 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.

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