Efficacy and Safety of High-Intensity, High-Frequency, Parallel Ultrasound Beams for Fine Lines and Wrinkles.

Background Ultrasound energy has been used for cutaneous rejuvenation, including treatment of fine lines and wrinkles. Ultrasound waves of high intensity can induce thermal injury in the dermis, which causes tissue coagulation and remodeling. Objective To examine the safety and utility of a novel ultrasound device that uses high-intensity, high-frequency, parallel ultrasound beams to improve fine lines and wrinkles of the face and neck. Materials and methods A prospective, multicenter, clinical study investigated the utility of this novel ultrasound device to improve fine lines and wrinkles. Sixty subjects were enrolled for single treatment to the face and neck. Results Fifty-eight subjects completed the study. The mean age was 58 years, and 87.9% were women. Fitzpatrick skin Types I to VI were represented. Assessments compared 12-week follow-up with baseline. Two blinded reviewers agreed in identifying pretreatment and post-treatment photographs for 78% of subjects. There was significant improvement of 1 to 3 Fitzpatrick Wrinkle and Elastosis Scale units in 86% of subjects. For investigator global improvement scores, 88% of subjects had improvement. Overall, 72% of subjects noted improvement, and the majority were satisfied. There were no device-related adverse events. Conclusion Treatment with a novel ultrasound device that uses high-intensity, high-frequency, parallel ultrasound beams safely improved the clinical appearance of fine lines and wrinkles of the face and neck.