Efficacy and Safety Evaluation of Microfocused Ultrasound Combined With 1550 nm Non-Ablative Fractional Laser for Facial Rejuvenation: A Randomized, Self-Controlled Clinical Study

This study intends to perform micro-focused ultrasound combined with 1550nm non-ablative fractional laser treatment on patients with facial photoaging, and evaluate its efficacy and safety for facial photoaging. It aims to observe whether the efficacy of micro-focused ultrasound combined with 1550nm non-ablative fractional laser for facial photoaging is superior to that of micro-focused ultrasound treatment alone.

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. The assessment and follow-up of various skin indicators of the patients were conducted before and after the treatment. Both the researchers and the subjects were in an open state. The researchers measured and evaluated various indicators of the patients' skin.

1. Preparatory work: Twenty-five volunteers with photoaging of the skin who met the inclusion criteria were recruited. After the first diagnosis, the informed consent form was signed. The basic information of the patients (age, gender, skin type, nature of work, sun exposure time, expression habits, etc.) was recorded. Digital photos of the front, 45-degree left and right sides, and 90-degree left and right sides were taken manually. The pictures were collected using the VISIA skin detector. The thickness of the dermis at the nasolabial sulcus was measured by skin ultrasound, and dermoscopy was performed. Non-invasive skin physiological indices were measured: skin elasticity, TEWL, EI, MI, and L*a*b* values (the average value was calculated by taking three points from different parts). Meanwhile, the patients underwent self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) scores.
2. Treatment process: Micro-focused ultrasound (using treatment heads S1.5, S2, N3, N4.5, P1.5, P2.0, P3.0, and P4.5) was performed once on both sides of the face. One side of the face was randomly selected as the experimental side. Immediately after the micro-focused ultrasound treatment, a 1550 nm non-ablative fractional laser (with a dot spacing of 0.75-1.25mm) was performed. Energy: 10-20 MJ. Repeat the treatment twice. The endpoint reaction is mild erythema and edema at the treatment site. Treat once. The second treatment was conducted 6 weeks after the first treatment. Micro-focused ultrasound treatment (using S1.5, S2, P1.5, and P2 treatment heads) was performed on both sides once. On the experimental side, 1550 nm non-ablative fractional laser (with a dot spacing of 0.75-1.25mm and an energy of 10-20mj) was performed immediately after micro-focused ultrasound treatment. The treatment was repeated twice. The endpoint response was mild erythema and edema at the treatment site (treated once). A total of 2 treatments were conducted. Use the moisturizing mask continuously for three days after each treatment. After the first diagnosis and the end of follow-up, the patients underwent Self-Rating Anxiety Scale (SAS) and Zong's Self-Rating Depression Scale (SDS) scores. The daily basic care products used by all patients were facial cleanser + simple moisturizer + sunscreen.
3. Follow-up: Follow-up was conducted before each treatment, 2 weeks after the end of the first treatment, 4 weeks after the end of the first treatment, and 2 weeks, 4 weeks, 6 weeks, and 12 weeks after the end of all treatments. During the follow-up, VISIA photography, digital camera photography, dermoscopy detection, high-frequency ultrasound detection of the skin and non-invasive skin detection were performed: skin elasticity, EI, MI, L*a*b* value, TEWL value. Self-rating Anxiety Scale (SAS) and Zong's Self-Rating Depression Scale (SDS) scores were conducted at the end of the first diagnosis and all follow-ups.

Record any adverse events during the trial, any laser and drug adverse reactions, the reasons for withdrawal from the trial, and any clinically significant abnormalities from baseline to the end of follow-up for safety evaluation.