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

NCT07466953 | Not Yet Recruiting Phase 3

• 1 other identifier: MSCEXO2026MA
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

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

Outcome Measures

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.

  Baseline to 6 months after the final treatment session

Secondary Outcomes (8)

• Change in VISIA wrinkle measurements

  Baseline to 6 months after the final treatment session

• Change in VISIA skin texture measurements

  Baseline to 6 months after the final treatment session

• Change in VISIA pore measurements

  Baseline to 6 months after the final treatment session

• Change in VISIA UV spot measurements

  Baseline to 6 months after the final treatment session

• Change in VISIA brown spot measurements

  Baseline to 6 months after the final treatment session

Study Arms (1)

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.

Biological: Mesenchymal Stem Cell-Derived Exosome

Interventions

Mesenchymal Stem Cell-Derived Exosome BIOLOGICAL

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.

Exosome Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mert Ersan: lead

Related Publications (2)

• 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.

  PMID: 39231070 BACKGROUND

• 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.

  PMID: 35689936 BACKGROUND

Central Study Contacts

hilal aybüke yıldız, MD

CONTACT

+905389675576; aybuke.yildiz@yeditepe.edu.tr

mert ersan, associate professor

CONTACT

+905544565025; mert.ersan@yeditepe.edu.tr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share