Enhancing Skin Rejuvenation A Single-Blind, Randomized Control Study on the Combined Efficacy of Aerolase 1064 nm YAG Laser and Exosomes Derived From Umbilical Cord Mesenchymal Stem Cells

1. Brief Summary This study evaluates the combined efficacy of the Aerolase 1064-nm Nd:YAG laser and umbilical cord-derived mesenchymal stem cell (UC-MSC) exosomes for skin rejuvenation. The investigation uses a single-blind, randomized, split-face design to compare laser alone versus laser plus topical exosomes. Participants undergo facial analysis, laser treatment, and structured follow-up assessments to measure changes in skin redness, wrinkles, spots, tone, and overall skin quality.
2. Detailed Description Detailed Description The study is conducted in Wichita, Kansas, a city of approximately 400,000 residents. Women constitute roughly 50% of the population, with an estimated one-third between ages 45-70. The percentage needed for this study represents less than 1% of the target demographic. Recruitment begins after IRB approval, with approximately 20 hours per week devoted to screening, enrolling, treating, and evaluating participants.

All study procedures occur at a single clinical site. The Principal Investigator (PI) is responsible for all recruitment, study activities, laser treatments, data entry, and follow-up coordination. The PI has over 30 years of nursing experience, including extensive clinical practice in women's health and mental health. Two additional nurse practitioners are available for consultation in case of medical concerns.

Participants are provided with study-related materials, including a consent form, PRO-X exosome information, a study protocol handout, and sunscreen. Eligible participants undergo baseline 3D HALO facial analysis and the initial Aerolase laser treatment. Participants draw a randomized ticket indicating "L" or "R," determining which facial side receives exosome application. The PI remains blinded to the allocation throughout the study.

Follow-up visits occur on Days 30, 45, and 60, with automated reminders sent via the clinic scheduling platform. Participants may contact the study site at any time with questions or concerns.

• Number of Subjects Twenty female participants are recruited from the Wichita metropolitan area. A minimum of ten participants is considered acceptable for study viability. All study visits occur at a single site.
• Recruitment Methods Recruitment uses flyers, social media posts, the clinic's website, Google business page, and professional networking meetings. Interested individuals contact the study site through phone, email, text message, or online scheduling. Eligibility screening includes verification of age and availability for the full study period.
• Study Duration Total participation time ranges from 60-80 days. Follow-up windows allow for minor scheduling adjustments. Total enrollment is expected to take 3-4 weeks, with full study completion-including data analysis-estimated at 180 days.
• Procedures Involved