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 mm(2) 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 320 treatment lines applied to each knee [corrected]. 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.
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 mm(2) 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 320 treatment lines applied to each knee [corrected]. 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.
Authors: Sabrina Fabi; Tatjana Pavicic; André Braz; Jeremy B Green; Kyle Seo; Jani Aj van Loghem Journal: Clin Cosmet Investig Dermatol Date: 2017-10-30