Efficacy and safety of high‐intensity, high‐frequency, non‐focused ultrasound parallel beams for facial skin laxity

Abstract Background Ultrasound energy has been used for dermal rejuvenation to treat fine lines, wrinkles and to lift lax skin. High intensity ultrasound waves induce thermal injury in the dermis, stimulating neocollagenesis and neoelastinogenesis. Objective To assess the efficacy, utility, and safety of a novel ultrasound device that uses high‐intensity, high‐frequency, non‐focused ultrasound parallel beams to lift lax facial skin in the eyebrow, submental, and neck areas. Materials and Methods Fifteen subjects aged 40–69 years were enrolled in a prospective clinical trial. Two treatment sessions were performed with the high‐intensity non‐focused ultrasound parallel beam device followed by 3‐ and 6‐month follow‐up visits. Treatment results were assessed by study investigators, evaluating baseline and posttreatment photographs by applying physician global aesthetic improvement scale. Pain was evaluated immediately after each treatment using 0–10 visual analog scale. Any adverse event that occurred during the study period was documented and examined. Results Fifteen subjects with a mean age of 55 ± 2 years completed the study. Photographs that were taken at baseline and follow‐up visits were compared and examined. An improvement pattern was detected in all treated areas in both follow‐up visits and persisted stably throughout the study. The mean pain score was 5.6 according to the visual analog scale. Conclusion The novel ultrasound device that uses high‐intensity, high‐frequency, non‐focused ultrasound parallel beam was shown to improve safely and efficiently facial lax skin resulting in eyebrow, submental, and neck skin lift while experiencing tolerable pain.