A prospective multicenter pilot study of the safety and efficacy of microfocused ultrasound with visualization for improving lines and wrinkles of the décolleté.

Abstract

A previous pilot study demonstrated microfocused ultrasound with visualization (MFU-V) to lift and tighten the décolleté produced significant and durable aesthetic improvements. To further evaluate the safety and effectiveness of MFU-V for improving lines and wrinkles of the décolleté in a larger patient population. Healthy women with moderate-to-severe décolleté skin lines and wrinkles were enrolled. After obtaining digital images, MFU-V was administered using 3 transducers emitting ultrasound at frequencies of 4 MHz and a focal depth of 4.5 mm, 7 MHz/3.0 mm, and 10 MHz/1.5 mm. During the procedure, 280 lines of discrete thermal coagulative points 25 mm long and 2 to 3 mm apart were applied to the treatment area. Additional imaging for masked assessments and live assessments were completed at 90 and 180 days. Among the evaluable subjects, 77 (66.4%) demonstrated aesthetic improvement at 180 days based on blinded assessments. Approximately, 75% and 65% of treated subjects demonstrated some degree of improvement at 90 and 180 days, respectively, and most were satisfied with treatment outcomes. Adverse events were generally mild. A single MFU-V treatment provided significant aesthetic improvement for moderate-to-severe décolleté lines and wrinkles for at least the 180-day duration of the study.