Safety and efficacy of UltraShape Contour I treatments to improve the appearance of body contours: multiple treatments in shorter intervals.

摘要

BACKGROUND: The UltraShape Contour I System (CE 0344; UltraShape Ltd., Yoqneam, Israel) is a noninvasive fat reduction and body contouring system currently approved for use outside the United States that utilizes focused ultrasound to selectively disrupt adipocytes. OBJECTIVE: To evaluate the clinical safety and efficacy of the Contour I system when the intervals between treatments are shortened. METHODS: Twenty-five healthy Caucasian women were selected from the patient population at two clinics in Paris, France, and received three 30- to 90-minute Contour I treatments in the abdominal region at two-week intervals. Safety parameters evaluated included adverse events, local skin reaction, and pain. Efficacy parameters evaluated included treatment area circumference, body weight, and comparison of before and after photos. Untreated thigh areas served as an internal control. Subjects were followed for 84 days after the last treatment (day 112). RESULTS: No adverse events occurred. The majority of subjects (n = 23; approximately 90%) reported no pain. Mean midline circumference (2 cm below midline) was reduced by 2.47 cm (P < .001) on day 14 after the first Contour I treatment, 3.51 cm (P < .001) on day 56, and 3.58 cm (P < .001) on day 112. Peak midline circumference reduction was 3.12 cm on day 112. Most patients (n = 14; 63%) reported a positive change in body contour. Mean thigh circumference (the control area) was unchanged; the relative change between treated and untreated areas of the abdomen was significantly different at all time points. Circumference and weight reduction were significantly correlated (r = 0.42-0.71) at all time points; mean weight decrease was not statistically significant. Circumference reduction on day 112 positively correlated with patients' subjective satisfaction scores. CONCLUSIONS: Our data showed that successive Contour I treatments at two-week intervals were safe and tolerable and also significantly reduced treatment area circumference.