Safety Study of Transcutaneous Focused Ultrasound for Non-Invasive Skin Tightening in Asians

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 (R) 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. (C) 2011 Wiley-Liss, Inc.