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

Abstract Background and Objectives Transcutaneous intense focused ultrasound has emerged as a novel technology for non‐invasive skin tightening. The objective of this study was to evaluate the safety profile of a transcutaneous focused ultrasound device for the treatment of facial skin laxity in Asians. Materials and Methods The patients received one to three full‐face treatments with the transcutaneous focused ultrasound device. Three transducers (7.0 MHz, 3.0 mm focal depth; 7.0 MHz, 4.5 mm focal depth; 4.0 MHz, 4.5 mm focal depth) were used to deliver a single pass of microthermal coagulation zones without any topical anesthetics. Standardized photos were taken at baseline and at each follow‐up with the Canfield Visia CR system® and were assessed by two independent physicians. Adverse effects were assessed up to 6 months post treatment. Subjective assessments in terms of pain and tolerability were also evaluated with patient questionnaires. Results Forty nine Chinese patients (skin types III–IV, mean age 53.3) completed a total of 68 treatment sessions. Transient erythema and edema were seen in the majority of patients. Focal bruising was present in up to 25% of treatment sessions. Two cases of post‐inflammatory hyperpigmentation were seen on the forehead at 1‐month post‐treatment. One patient experienced focal twitching over the lower eyelid at 1‐month follow‐up, which was clinically consistent with hemifacial spasm and was unrelated to the ultrasound device. The degree of pain during treatment was recorded as severe in 54.4% of treatment sessions. Conclusions Transcutaneous intense focused ultrasound appeared to be safe for non‐invasive facial skin tightening in Asians. Adverse events were mild and transient. Pain control during treatment should be optimized. No serious permanent or delayed side effects were noted up to 6 months post treatment. Lasers Surg. Med. 43:366–375, 2011. © 2011 Wiley‐Liss, Inc.