Enhancing Skin Rejuvenation Using Laser and Exosomes

NCT07281690 | Completed Phase 3 FDA Drug

• 1 other identifier: 25-08-089-2058
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Laser Therapy; Exosomes

Outcome Measures

Primary Outcomes (1)

• Title: Mean Change in Nurse-Photographic Rating Scores Between Exosome-Treated and Control Sides

  Primary Outcome Measure 1 Description: This outcome measures the difference between the exosome-treated and control sides using independent evaluations by three nurse practitioners. Ratings are scored on a 1-3 scale (1 = left side better, 2 = right side better, 3 = no difference). Time Frame: Day 60 Scoring Interpretation: Higher values indicate greater improvement on the exosome-treated side.

  60 days

Secondary Outcomes (1)

• Title: Mean Change in HALO Image Pro 3D Analyzer Scores (Redness, Wrinkles, Pigmentation, Tone)

  60 days

Other Outcomes (1)

• Title: Mean Change in FACE-Q Appearance Appraisal Scores Between Exosome-Treated and Control Sides

  60 days

Study Arms (1)

Experimental (Split-Faced Design)

EXPERIMENTAL

All participants received a 1064-nm Nd:YAG laser treatment to the entire face. Exosomes (UC-MSC-derived topical serum) were applied only to the randomly assigned side of the face. The opposite side received laser only.

Device: 1064-nm Nd:YAG Laser Treatment; Biological: Topical Umbilical Cord-Derived Exosomes (UC-MSC Exosomes)

Interventions

Topical Umbilical Cord-Derived Exosomes (UC-MSC Exosomes) BIOLOGICAL

Description: Topical application of a laboratory-processed umbilical cord lining mesenchymal stem-cell-derived exosome serum. Applied twice daily to the randomly assigned half of the face for 60 days following each laser session. Other Name: Exosome serum; UC-MSC exosome solution.

Experimental (Split-Faced Design)

1064-nm Nd:YAG Laser Treatment DEVICE

A non-ablative 1064-nm Nd:YAG laser (Aerolase Neo Elite) delivered to the entire face at each treatment visit.

Experimental (Split-Faced Design)

Eligibility Criteria

• Age: 45 Years - 70 Years
• Gender Eligibility Details: Female at birth
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females between the ages of 45-70

You may not qualify if:

• Women who are pregnant

Sponsors & Collaborators

• Laser Beamer Skincare: lead

Study Sites (1)

LaserBeamerSkincare

Wichita, Kansas, 67212, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects receive lasering on their entire face and apply exosomes to a randomly assigned side of one side of their face. 3 laser sessions and 60 days of exosomes applied daily.

Study Record Dates

• First Submitted: October 27, 2025
• First Posted: December 15, 2025
• Study Start: March 1, 2025
• Primary Completion: July 17, 2025
• Study Completion: July 17, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-10

Locations

US (1)