Safety study of transcutaneous focused ultrasound for non-invasive skin tightening in Asians

Abstract

BACKGROUND: The objective of this study is to determine the safety of a novel focused ultrasound device (Ulthera System1) in the treatment of facial skin laxity in Asians. STUDY: The patients received one to two full-face treatments with the transcutaneous focused ultrasound device. Three transducers (7.5 MHz, 3.0mmdepth; 7.5 MHz, 4.5mmdepth; 4.0 MHz, 4.5mm depth) were used to deliver a single pass of microthermal areas of coagulation without any topical anaesthetics. Standardized photos were taken with the Canfield Visia CR system1 and all patients were clinically assessed for adverse effects up to 6 months post treatment. Subjective assessments were also evaluated with patient questionnaires. RESULTS: 49 Chinese patients (skin type III–IV, mean age 53.3) completed a total of 67 treatment sessions. Focal bruising and numbness were present in 13.42% and 1.49% of treatment sessions respectively at 7 days post-treatment. Two cases of mild post-inflammatory hyperpigmentation over the forehead were noted at one month post-treatment, both of which responded to topical bleaching agent. One patient experienced focal fasciculation over the lower eyelid at one month post-treatment, clinically consistent with hemifacial spasm, which was unlikely to be device-related. The treatments were well-tolerated with an average pain score of up to 6.88 out of 10. CONCLUSION: Transcutaneous high intensity focused ultrasound appears to be safe and well-tolerated for non-invasive facial skin tightening in Asians. Adverse events are mild and transient. No serious permanent or delayed side-effects were noted up to 6 months post treatment.