Efficacy and Safety Evaluation of Microfocused Ultrasound Combined With 1550 nm Non-Ablative Fractional Laser for Facial Rejuvenation

This study adopted the research method of a single-center case-control study. According to the inclusion and exclusion criteria, 25 patients with facial photoaging were included. After the treatment, various skin indicators of the patients were evaluated and followed up. Both the researchers and the subjects were in an open state. The researchers measured and evaluated various indicators of the patients' skin. Patients diagnosed with facial photoaging underwent VISIA photography, digital camera photography, non-invasive skin testing, dermoscopy testing and high-frequency skin ultrasound testing after enrollment. On the day of enrollment, micro-focused ultrasound (using treatment heads S1.5, S2, N3, N4.5, P1.5, P2.0, P3.0, and P4.5) was performed on both sides of the face once. One side of the face was randomly selected as the experimental side, and a 1550 nm non-ablative fractional laser treatment was performed immediately after the micro-focused ultrasound treatment once. For the second treatment, micro-focused ultrasound (using S1.5, S2, P1.5, and P2.0 treatment heads) was performed on both sides once. The experimental side was treated with 1550 nm non-ablative fractional laser once immediately after the micro-focused ultrasound treatment. The research period was May, including a treatment period of 2 months. Follow-up was conducted every two weeks for a total of 10 times, all of which were on-site visits. The grace period during the visit is ±3 days.

NCT Number	NCT07107308
Lead Sponsor	Second Affiliated Hospital of Xi'an Jiaotong University
Conditions	Photo-aged Skin
Enrollment	25 participants
Start Date	2024-11-01
Primary Completion	2025-08-30 (estimated)
Study Completion	2025-08-30 (estimated)
Updated on ClinicalTrials.gov	2025-08-06