Evaluation of Micro-Focused Ultrasound for Lifting and Tightening Neck Laxity

May 2016 | Volume 15 | Issue 5 | Original Article | 607 | Copyright © May 2016


Leslie Baumann MDa and Brian Zelickson MDb

aBaumann Cosmetic & Research Institute, Inc., Miami Beach, FL
bZel Skin and Laser Specialist, Edina, MN

Abstract
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.

J Drugs Dermatol. 2016;15(5):607-614.

INTRODUCTION

A novel device integrates micro-focused ultrasound with high-resolution ultrasound visualization (MFU-V) to cause sub-dermal collagen denaturation and subsequent de novo collagen synthesis and remodeling.1,2 When applied to areas of lax skin, the result is significant skin lifting and tightening.3-7 MFU-V has been demonstrated to be safe and effective in numerous clinical trials as a noninvasive aesthetic treatment, and it is FDA-cleared to non-invasively lift tissues of the eyebrow, neck, and submentum (Ulthera® System; Ulthera, Inc., Mesa, AZ).8
Despite the similarities in age-related changes in the skin and connective tissue, the clinical presentation of each patient is unique, and MFU-V treatment must be customized for each patient. The MVU-V device uses six transducers that emit ultrasound energy at a range of frequencies and at multiple focal depths.8 Each ultrasound transducer can also provide tissue imaging to a depth of 8 mm. The MFU-V device utilizes a computer-driven platform that enables the clinician to visualize the proposed treatment with ultrasound-imaging transducers and develop a treatment plan prior to applying micro-focused ultrasound energy.
Using these transducers, micro-focused ultrasound is delivered in a series of lines at discrete tissue depths, including the variable depths of the superficial muscular aponeurotic system. Thermal coagulation points are formed when ultrasound energy is focused to a point less than 1 mm3 in size below the skin surface. At such points, 95% of the delivered ultrasound energy is converted to heat, thereby raising the local temperature to ~65°C. At this temperature, denaturation and contraction of collagen and stimulation of neocollagenesis occurs while the superficial layer of skin and other intervening tissues remain unaffected.2 Each line of treatment consists of a row of thermal coagulation points at a single focal depth. These treatment lines are typically spaced 2-3 mm apart.
MFU-V has proven to be effective for lifting and tightening lax skin on the face and neck when focused ultrasound is delivered at a single focal depth.3-6 The present nonrandomized, prospective study was performed to determine whether the customized application of MFU-V at two focal depths can produce improved clinical results compared to treatment at a single focal depth.

METHODS

Study Subjects

The study enrolled 71 healthy men and women that were 30 to 65 years of age and expressed interest in MFU-V for lifting and tightening of the face and neck. Subjects were required to have
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