Microfocused Ultrasound With Visualization for Skin Tightening and Lifting: My Experience and a Review of the Literature Sabrina G. Fabi, MD*†

The author has indicated no significant interest with commercial supporters.

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n an effort to meet patient demands of no downtime skin-tightening procedures, many nonablative skin resurfacing treatments have emerged (e.g., monopolar, bipolar, tripolar radiofrequency) to induce collagen shrinkage and remodeling while preserving the epidermis. Therapeutic ultrasound uses high-energy levels of >5 W/cm2 that can be tightly focused to penetrate deeper in the subcutaneous tissue and form precise thermal coagulation points (TCPs), which denature collagen fibers and stimulate neocollagenesis, leading to tightening and lifting of the skin. This ability to focus energy and completely bypass the epidermis and papillary dermis allows higher temperatures to be reached at the focal point (60–70°C), which optimizes collagen production,1,2 while avoiding the undesirable postprocedural effects observed with epidermal disrupting laser procedures. Microfocused ultrasound’s (MFU) ability to confine heat to small focal regions (approximately 1 mm3) with a combination of precision and depth gives it several potential advantages over other energy-based treatment modalities offered in the clinical setting. Having personally performed over 700 treatments with MFU both clinically and in 3 clinical trials, the technology has rounded out the authors armamentarium of tools used to rejuvenate the face and body in a more 3-dimensional manner. The microfocused ultrasound with visualization (MFU-V) system (Ulthera; Ulthera Inc., Mesa, AZ) has

the ability to deliver focused ultrasound energy at preselected depths of 4.5, 3, and 1.5 mm using different transducers, while providing real-time imaging to ensure accurate energy delivery to the intended tissue plane. In 2009, it received Food and Drug Administration (FDA) clearance for a noninvasive brow lift3 and subsequently to lift lax submental and neck skin. In the author’s personal experience, MFU-V is an ideal treatment in a number of anatomic regions,4 as different facial and nonfacial areas have a wide range of thicknesses, allowing one to target both cutaneous layers in the skin, such as the reticular dermis, and fibromuscular layers, such as the submuscular aponeurotic system on the face and superficial fibromuscular tissue encasing muscles on the body.4–8 Treatment with MFU-V creates small focal TCPs in the skin and fibromuscular planes, causing thermally induced contraction of tissue, initiating a “wound-healing” response to stimulate the formation of new tissue and collagen remodeling, resulting in both skin tightening and a clinically visible and quantifiable lift.3,4,7–9

Clinical Studies Numerous studies have been reported the safety and effectiveness of MFU-V for tightening and lifting lax facial, neck, chest, arm, elbow, medial thigh, knee, buttock, and abdominal skin (Figures 1 and 2).3–8,10 In the initial clinical trial assessing the ability of MFU to

*Goldman, Butterwick, Fitzpatrick, Groff & Fabi, Cosmetic Laser Dermatology, San Diego, California; †Department of Dermatology, Division of Medicine, University of California, San Diego, California

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© 2014 by the American Society for Dermatologic Surgery, Inc. Published by Lippincott Williams & Wilkins ISSN: 1076-0512 Dermatol Surg 2014;40:S164–S167 DOI: 10.1097/DSS.0000000000000233

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Figure 1. A 69-year-old woman, 1 treatment with MFU-V using the 4.5- and 3-mm depth transducers to the full face and upper neck for a total 420 lines, 12 months later (with no other cosmetic procedures performed in the interim).

tighten and lift the brow, 36 subjects were medicated with topical anesthetic and had MFU-V applied to the full face and neck using 3 transducers: 4 MHz, 4.5-mm focal depth; 7 MHz, 4.5-mm focal depth; and 7 MHz, 3.0-mm focal depth.6 Among the 35 evaluable subjects, 30 (86%) were judged by blinded assessors to show clinically significant brow lift, with a mean elevation in eyebrow height of 1.7 mm (p = .00001) at 90 days after treatment.3 To confirm that skin tightening and lifting seen clinically could be attributed to an increase in collagen, Suh and colleagues performed a single MFU-V treatment on 22 Korean

patients and obtained facial skin biopsies (n = 11) before and 2 months after treatment. Histology showed greater dermal collagen with thickening of the dermis and straightening of elastic fibers in the reticular dermis after treatment.11 This correlated with improvement reported by both investigator and subjects in nasolabial fold and jawline appearance. To evaluate MFU-V for tightening and lifting lax facial and neck skin, as well as to determine patient satisfaction in paying patients, and what factors (i.e., age, smoking, skin type, ethnicity, alcohol intake, stress

Figure 2. A 49-year-old woman, 1 treatment with MFU-V using both the 4.5- and 3-mm depth transducers on each buttock for a total of 720 lines, 6 months later.

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MFU-V FOR SKIN TIGHTENING AND LIFTING

study evaluating lifting and tightening of the neck alone, dual-depth treatment of the lower neck with the 4 MHz (4.5-mm focal depth) and 7 MHz (3.0-mm focal depth) transducers (n = 31) showed a trend toward greater aesthetic improvement than singledepth treatment with the 7 MHz (3.0-mm focal depth) transducer (n = 24), as measured by Physician Global Aesthetic Improvement Scale (PGAIS) and Subject Global Aesthetic Improvement Scale (SGAIS) at Days 90 and 180.13

Figure 3. Diagram depicting facial and nonfacial areas that have been treated with MFU-V.

level, illness, and quality of sleep) make patients more or less likely to respond to treatment, a retrospective evaluation was performed in our clinic on 48 patients, median age of 58.5 years (range, 31–85 years), who received a single full face and upper neck MFU-V treatment using the manufacturer’s recommended protocol in 2011 that called for 370 to 420 treatment lines.12 Based on the blinded reviewer assessments, the majority of subjects (67%) demonstrated improvement in appearance 180 days after treatment, with more than 80% of subjects indicating that they noticed improvement in face and neck characteristics at both 90 and 180 days after treatment. No difference was seen between likelihood to respond to treatment and age (those 60 years or younger vs those older than 60 years), Fitzpatrick skin type, alcohol intake, major illness, and sun avoidance. In a 2-site

When MFU-V was evaluated at our practice for its efficacy and safety in lifting, tightening, and reducing wrinkles of the décolletage (n = 24), a statistically significant improvement in chest wrinkles (p < .0001), breast lift (p < .0001), SGAIS, and PGAIS was seen at Days 90 and 180.7 These results were corroborated in a multicenter trial of 125 subjects, and an application for an FDA indication for the improvement of chest wrinkles has been filed.14 Similarly, when MFU-V was evaluated to lift and tighten lax elbow skin (n = 20), preliminary results at Day 90 showed 87.5% improved by SGAIS (p < .0001) and 93.8% improved by PGAIS (p < .0001), with similar findings seen at Day 180.8 Results on lifting and tightening the buttocks have also been favorable, with interim study results showing 87.5% improved by SGAIS (p < .0001) and 93.8% improved by PGAIS (p < .0001) at Day 180. In a study by Alster and Tanzi,4 GAIS scores revealed significant improvement in arms, thighs, and knees 3 and 6 days after treatment, with the upper arms and knees demonstrating more skin lifting and

Figure 4. A 39-year-old woman demonstrating striated erythematous edematous plaques after 1 treatment with MFU-V using both the 4.5- and 3-mm depth transducers for a total of 240 lines, 2 weeks later, after applying a Class 1 topical steroid daily with massage for 1 week.

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tightening than the thighs. Areas receiving dual-plane treatment had slightly better clinical scores than those receiving single-plane treatments in all 3 sites.

Safety Microfocused ultrasound with visualization is a relatively safe procedure, with no long-term side effects published to date. In the author’s experience, commonly reported adverse events with MFU-V in both facial and nonfacial areas depicted in Figure 3 include transient erythema (lasting less than 24 hours), mild edema (lasting 2–4 weeks), dysesthesias (lasting 2–4 weeks), and occasional bruising (

Microfocused ultrasound with visualization for skin tightening and lifting: my experience and a review of the literature.

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