Abstract
Introduction: Public interest in noninvasive, aesthetic treatments for the rejuvenation of appearance continues to grow. The following prospective, open-label, nonrandomized trial was conducted to evaluate the safety and efficacy of micro-focused ultrasound with visualization (MFU-V) for achieving lift and tightening of lax skin above the knee. Materials and methods: Healthy adult women (N = 30) with mild- to moderate bilateral skin laxity above the knees were enrolled. MFU-V was applied to a grid of eight 25 mm2 squares above each knee. MFU-V was first applied using a 4 MHz, 4.5 mm transducer followed by a 7 MHz, 3.0 mm transducer. Approximately 480 treatment lines applied to each knee. The primary efficacy endpoint was lifting and tightening of lax skin above the knee as determined by the principle investigator using the Physician Global Aesthetic Improvement Scale (PGAIS). Results: Among 28 evaluable subjects, 24 subjects (86%) showed improved lifting and tightening of knee skin laxity at 90- and 180-day follow-up visits. Three subjects showed no change and the appearance of one subject worsened. There were no adverse events or evidence of skin injury. Conclusion: Similar to its safety and efficacy for tightening facial skin and reducing wrinkles, MFU-V is an effective, noninvasive method for reducing skin laxity and improving the appearance of skin above the knee. ClinicalTrials.gov Identifier: NCT01708434.
Acknowledgements
The author acknowledges the editorial assistance of Dr. Carl Hornfeldt during the preparation of this manuscript. Funding for this study was provided by Ulthera, Inc., Mesa, AZ.
Declaration of interest: The authors report no declarations of interest. The authors alone are responsible for the content and writing of the paper.