A Split Face Study to Determine the Significance of Adding Increased Energy and Treatment Levels at the Marionette Folds

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Abstract
Microfocused ultrasound with visualization (MFU-V) has become a safe and effective means to tighten skin and subdermal structures by optimizing the amount of joule energy and treatment tissue planes for improved customization for the individual patient. To date, there have been an absence of split treatments to verify algorithms. The aims of this institutional review board-approved investigation and clinical experience were to clarify the safety and efficacy of current treatment guidelines. This split-face investigation quantified tissue displacement at the marionette folds after single treatments of 2 different treatment densities or number of lines and 2 vs 3 planes of treatment with matched-orientation photography, elasticity measurements, subjective assessments by patient (SGAIS), and blinded-investigator global investigation (IGIAS) analyses at baseline, 180 days post treatment (D180), and 360 days post treatment (D360). Clinical studies, utilizing these algorithms to treat regional areas of the forehead, periorbitum, face, neck, and décolleté, were analyzed by (IGIAS) assessment, pain scoring, and incidence of complications and side effects at D180 and D360. Post hoc analyses at D180 and D360 in pilot studies 1 and 2 demonstrated greater tissue displacements, elasticity measurement, and pain scores, supported by SGAIS and IGAIS assessment with the use of higher amounts of joule energy and treatment planes than those used on the contralateral reference marionette folds at D180 and D360. Pain scores after use of each transducer or at the end of the procedure showed variability at different regional areas with more discomfort noted with treatments at the deepest and most superficial tissue planes. There were no major adverse reactions and minimal short-termed side effects in the entire study. Optimization, customization, and safety were observed with the use of current MFU-V algorithms as clarified by the findings in this investigation. Further investigations with multiple sessions will be required to advance this unique noninvasive technology for tissue lifting.

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