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

Condition(s) studied

Investigational drug(s) / intervention(s)

Microfocused Ultrasound: Before treatment, clean the treatment area, mark the treatment zone, and evenly apply a layer of ultrasound coupling agent about the thickness of a coin on the treatment area. The patient's face was treated with S1.5, S2, N3, N4.5, P1.5, P2.0, P3.0 and P4.5 treatment heads respectively. After the treatment, the face was cleaned and a medical mask was applied for 15 minutes. After the treatment, attention was paid to moisturizing and sun protection.

Erbium-Doped Fiber Laser: Doctors and patients wear corresponding protective glasses. Apply cold gel to the treatment area on the patient's face and select certain treatment parameters based on the patient's skin lesion condition and skin type. After the treatment, clean your face. Decide whether to apply ice based on the severity of the skin lesion reaction. If ice application is necessary, the regular ice application time is 15 to 30 minutes, and apply a medical mask for 15 minutes. After the treatment, pay attention to moisturizing and sun protection.

Study summary

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.

Eligibility

Primary outcome measure(s)

• GAIS(Global Aesthetic Improvement Scale) Score — week 0、4、8、12、16
  Minimum 0 points, maximum 4 points. The higher the score, the better the therapeutic effect.

Trial sites (1)

More Second Affiliated Hospital of Xi'an Jiaotong University trials in China