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

  1. Standardized skin evaluation questionnaire on Days 1, 30, 45, and 60.
  2. HALO 3D facial imaging on Days 1, 30, 45, and 60.
  3. Aerolase 1064-nm Nd:YAG laser treatment to the full face at each visit.
  4. Randomized assignment of exosome application to either the left or right facial side.
  5. Twice-daily exosome application at home on the assigned side.
  6. Daily sunscreen use on the full face for the duration of the study. The study design is a single-blind, randomized, controlled, interventional trial evaluating changes in key skin parameters, including moisture, laxity, wrinkles, pigmentation, texture, tone, radiance, and pore size.

HALO Analyzer devices automatically calibrate before each session, ensuring consistency in measurement. Identical photographic conditions are maintained across all time points.

Laser treatments follow Aerolase manufacturer guidelines tailored to Fitzpatrick skin type. The PI is trained in all device operations, ensuring standardization across sessions.

14) Data Management Objective data are collected through the HALO Analyzer and stored under de-identified subject numbers. Paired t-tests are used to compare pre- and post-treatment values for each facial side. The paired design accounts for within-subject variability.

Data verification includes cross-checking HALO outputs with participant self-assessments. Photographic documentation is reviewed immediately after capture to ensure clarity.

14.2 Confidentiality and Data Security All participant data-including photographs and self-assessments-are stored on a password-protected computer in a locked office. De-identified numeric codes replace participant names after enrollment. Only the PI and designated blinded nurse practitioner raters have access to study data.

Data will be securely retained for three years.

• Protecting Privacy of Subjects Participants are assigned a unique study number upon enrollment. All study forms, HALO images, and assessments are stored under this number. Only the PI has access to identifying information required for scheduling or follow-up communication. Nurse practitioner raters evaluate photos labeled with de-identified numbers only.
• Future Use of Data De-identified data will be maintained for three years and may be used for scientific publication or future research analyses as stated in the consent. No identifiable information will be released.
• Ensuring Safety of Subjects Risks are minimal and may include transient redness or irritation from the laser or topical products.
• Withdrawal of Subjects Participants may withdraw at any time for scheduling or personal reasons. Withdrawal reasons will be documented when possible. Data from participants who withdraw prior to completing the study will not be included in the final analysis.

Inclusion Criteria:

• Females between the ages of 45-70

Exclusion Criteria:

• Women who are pregnant

Female at birth

Individual participant data (IPD) from this study will not be shared. The dataset includes small-sample photographic images and FACE-Q responses that cannot be fully de-identified without compromising participant privacy. In addition, the study was not designed with external data sharing as a planned component.

Participants were aware of the side of the intervention, but the investigator performing outcome assessments and data analysis was masked, meaning the subjects applied the exosomes to the side of the face that was randomly assigned by drawing a ticket with a de-idenifying number and L or R-the side the exosomes were to be applied.