Background: A novel device using micro-focused ultrasound with high-resolution ultrasound visualization (MFU-V) produces non-invasive lifting and tightening of lax skin on the face and neck when treatment is delivered at a single focal depth (Ulthera® System; Ulthera, Inc., Mesa, AZ). OBJECTIVE: The following study was performed to test the hypothesis that customized application of MFU-V at two focal depths will produce clinical results that are superior to treatment at a single focal depth. METHODS AND MATERIALS: Adult subjects (N=71) with skin laxity in the lower face and neck were enrolled; 64 met all entrance criteria and received treatment. On the basis of physical and anatomical characteristics, patients were assigned in nonrandomized fashion to one of three treatment groups to undergo treatment on the submental, submandibular, lower neck, and platysmal areas with MFU-V at single or dual depths. RESULTS: Among evaluable subjects (N=64), investigator-assessment and subject-self-assessment demonstrated improved aesthetic changes at 60, 90, and 180 days after treatment. Overall, subjects that received MFU-V at two focal depths to the entire treatment area achieved slightly greater aesthetic improvement than subjects receiving MFU-V at single focal depths. There were no unexpected adverse events. CONCLUSION: Applying treatment with MFU-V at two focal depths may provide improved aesthetic results in some subjects. D
|Number of pages
|Journal of Drugs in Dermatology
|Published - May 2016
Bibliographical noteFunding Information:
This study was sponsored by Ulthera, Inc., Mesa, AZ. The authors acknowledge the editorial assistance of Dr. Carl Hornfeldt, Apothekon, Inc., during the preparation of this manuscript.
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