peer-review | Skin tightening

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Micro-Focused

Ultrasound

Skin Tightening Sabrina Guillen Fabi evaluates the use of a micro-focused ultrasound with visualization device for non-invasive skin tightening of the face, neck, hands, and other anatomical areas COVER STORY

Sabrina Guillen Fabi, MD, Goldman, Butterwick, Fitzpatrick, Groff and Fabi Dermatology Cosmetic Laser San Diego, CA

email: [email protected]

Keywords Micro-focused ultrasound, skin lifting, skin tightening, superficial musculoaponeurotic system, collagen, face, neck

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ABSTRACT The only available FDA-cleared microfocused ultrasound with visualization (MFU-V) device is currently indicated as a non-invasive aesthetic treatment to lift the eyebrow, lax submental, and neck tissue and is the only non-invasive treatment specifically cleared by the US FDA for improving lines and wrinkles of the décolleté. An integral part of the device is a transducer which ensures proper coupling to the skin, confirms appropriate treatment depth, and avoids non-target tissue. The available frequency/focal depth transducers include a 4 MHz/4.5 mm, 7 MHz/4.5 mm, 7 MHz/3.0 mm, 10 MHz/1.5 mm and

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a 7  MHz/3.0  mm narrow focal depth transducer. Each transducer delivers a beam of high-intensity focused ultrasound to the selected focal depth where tissue is heated to >60°C at the thermal injury zone where collagen in the superficial musculoaponeurotic system undergoes thermal coagulation and subsequent contraction and remodeling. Techniques for achieving skin lift and tightening with MFU-V are continuously undergoing change and recent refinements include treatment with two transducers with different focal depths to treat the same area, the addition of vertical vectoring and increasing the number of treatment lines. Independent investigators have expanded

ltrasound, similar to audible sound, is an oscillating pressure wave; however, it has a frequency beyond the limit of the human hearing1. Since ultrasound will return as an echo when directed at solid objects, diagnostic ultrasound or sonography has been used in human medicine for many years. The properties of ultrasound also enable it to be focused like a beam of light with a high degree of precision. At frequencies of 1–7 MHz, ultrasound can be very tightly focused2. If directed toward body tissue and the power of the ultrasound source is sufficiently high, the temperature will increase to more than 60 °C within the focal zone, causing tissue proteins to coagulate. This is referred to as high-intensity focused ultrasound (HIFU). An important aspect of HIFU is that although the damaging focal point is located several millimeters below the surface of the skin, tissue above and below the focal point remain unaffected1. HIFU has become an important tool for treating serious medical conditions such as tumors3. More recently, the development of

the off-label use of MFU-V to include the upper arms, elbows, thighs, knees, and buttocks. MFU-V is very well tolerated with most patients reporting mild or moderate treatment discomfort. MFU-V is safe across all Fitzpatrick skin types. Treatmentrelated adverse events are generally mild or moderate in severity, transient in duration and most often consist of local erythema, edema and bruising. No serious adverse events or events of a systemic nature have ever been reported. Ideal patients have mild to moderate skin laxity and mild lipoptosis while those with extensive skin laxity, heavy lipoptosis with jowling, or marked platysmal banding are less likely to achieve aesthetic benefit.

micro-focused ultrasound (MFU) enables targeting the facial superficial musculoaponeurotic system4.

Preclinical studies

Superficial musculoaponeurotic system The superficial musculoaponeurotic system (SMAS) is a subcutaneous, fan-shaped structure that covers the face5 and connects the facial muscles with the dermis6. It has been described as a composite fibro-fatty layer made up of elastic fibers in close relationship to collagen fibers interspersed with fat cells7. Superiorly, it is attached to the internal aspect of the frontalis muscle, and inferiorly it is continuous with the platysma muscle5. Anteriorly, it is contiguous with the platysma muscle and also part of the orbicularis oculi muscles. Within the nasolabial fold region, it is connected to the levator labium superius oris, orbicularis oris, depressor anguli oris, and risorius muscles. Posteriorly, its attachments include the perichondrium of the tragal cartilage and the sternocleidomastoid muscle on the mastoid. The most common SMAS architecture (Type 1) is a meshwork of fibrous septa which envelops fat cells6.

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If directed toward body tissue and the power of the ultrasound source is sufficiently high, the temperature will increase to more than 60 °C within the focal zone, causing tissue proteins to coagulate.

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The interconnecting fibrous network is anchored to the periosteum or connected to the facial muscles. Type 1 SMAS morphology is found in the forehead, parotid, zygomatic, and infraorbital areas and also in the lateral part of the nasolabial fold and is more susceptible to the effects of ageing6. The second architectural model (Type 2) is a meshwork of intermingled collagen and elastic fibers and muscle fibers found in the upper and lower lip6.

Effects of microfocused ultrasound on the superficial musculoaponeurotic system

Micro-focused ultrasound with visualization system Currently, only one non-invasive aesthetic treatment using MFU-V has been cleared by the US FDA (Ulthera System; Ulthera, Inc., Mesa, AZ). The device is currently indicated for use as a non-invasive dermatological aesthetic treatment to lift the eyebrow, lax submental and neck tissue and is the only noninvasive treatment specifically cleared by the FDA for improving lines and wrinkles of the décolleté14. An integral part of the device is the Ulthera DeepSee transducer which permits ultrasound visualization of target tissues up to 8 mm below the surface of the skin. The visualization transducer ensures proper coupling of the transducer to the skin, confirms appropriate treatment depth, and avoids non-target tissue, such as bone. The available frequency/focal depth transducers include a 4 Mhz/4.5 mm, 7 Mhz/4.5 mm, 7 Mhz/3.0 mm, 10 Mhz/1.5 mm, and a 7 Mhz/3.0 mm narrow focal depth transducer. each transducer delivers a beam of hIFU to the selected focal depth where tissue is heated to >60°C at the 1–1.5 mm3 thermal injury zone and collagen undergoes thermal coagulation.

Thermal injury is known to cause collagen to contract; however, prior to the introduction of hIFU to cosmetic dermatology, this effect was limited to the application of superficial heat such as lasers8,9. Preclinical studies involving the use of hIFU to treat the SMAS were initially performed using ex vivo porcine tissues10 and human cadaver facial tissue11,12. By manipulating the ultrasound frequency, focal depth, power output, and duration of exposure, the Application of MFU-V temperature within the dermis could be briefly raised to The choice of which transducer to use depends on the 60 °C resulting in a discrete and reproducible zone of anatomical area being treated. For example, areas with thermal coagulation. These small (0.5 Joules as focal lines applied to a treatment area depends on the size of areas of denatured collagen. These thermal injury zones the area and chosen protocol. Treatment guidelines were produced in the expected linear pattern and were including transducer selection and suggested treatment consistent in size and depth from zone to zone. Increasing patterns over different areas of the face are provided by source power did not increase the depth of the epicenter the manufacturer16. of the thermal injury zone.

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| Precautions The most worrisome potential complication is motor nerve paresis. The areas at the greatest risk for injury are the temporal branch of the trigeminal nerve and the marginal mandibular nerve, where the depth of the nerve becomes relatively superficial15. Among the 39 MFU-V-treated patients in one recent report there was high incidence of transient buccal (N=1), marginal mandibular (N=1), and frontal branch nerve paralysis (N=1)17. These effects can be prevented by avoiding treatment directly over the mandible or facial nerves. Because there are no commercially available eye shields known to protect the eye from ultrasound energy, treatment should not be done inside the orbital rim15. The thyroid gland should be marked before treatment to avoid inadvertently exposing the area to ultrasound energy.

Contraindications Contraindications to the use of the MFU-V system include the presence of open wounds or lesions, severe or cystic acne, the presence of active implants (such as pacemakers and Other defibrillators) or metallic implants in studies have also the planned treatment area, and pregnancy. Relative demonstrated the contraindications include illnesses, beneficial effects conditions or medications that may of treating the face impair wound healing.

and neck with Clinical studies single-depth Efficacy of MFU-V for lifting MFU-V. lax skin on the face and neck Single-depth treatment Techniques for achieving skin lift and tightening with MFU-V are continuously undergoing change and refinement. The first published clinical MFU-V trial was a blinded, prospective cohort study18. Three MFU-V transducers with a frequency/focal depth of 4 MHz/4.5 mm, 7 MHz/4.5 mm, and 7 MHz/3.0 mm were applied as a single treatment to the forehead, temples, cheeks, submental region, and side of the neck. The choice of transducer was based on skin thickness. Among the subjects evaluable at 90 days post-treatment (N=35), 86% were judged by blinded clinician evaluators to show clinically significant brow lift (p=0.00001) with a mean maximum brow elevation of 1.9 mm. Other studies have also demonstrated the beneficial effects of treating the face and neck with single-depth MFU-V. Among subjects treated with 7.5 MHz/3.0 mm and 4.4 MHz/4.5 mm transducers (N=22), all showed nasolabial fold and jaw line improvement19. Dual depth MFU-V treatment A refinement to treatment with MFU-V is the use of two transducers with different focal depths to treat the same area. One study compared improvements to the neck following single- and dual-depth MFU-V treatment20. Among subjects receiving a single (3 mm) depth treatment on the neck (N=34), blinded assessment

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| skin tightening | peer-review indicated 74.2%, 78.1%, and 42% of subjects were improved at 60, 90, and 180 days, respectively. Among subjects receiving dual depth (3 mm and 4.5 mm) treatment, 53.3%, 79.3%, and 93.1% were improved at 60, 90, and 180 days, respectively. The effect of dual depth MFU-V treatment was also assessed on facial areas including the temples, cheeks, submental region, and neck using 4 MHz/4.5 mm and 7 MHz/3.0 mm transducers21. After 90 days, blinded clinician evaluators judged 8 of 10 evaluable subjects (80%) as showing clinical improvement. Specifically, two were significantly improved, four were moderately improved, and two were mildly improved. Based on subject self-assessment, 90% of subjects were improved. The largest clinical study of the effectiveness of MFU-V for rejuvenating the lower face was a prospective non‑randomized clinical trial (N=103)22. Threedimensional images obtained at baseline and 3 months post-treatment were assessed qualitatively by three blinded reviewers and quantitatively using threedimensional computer software. Among the evaluable subjects (N=93), qualitative improvement in skin laxity was observed in 58.1% of patients and quantitative noted overall improvement in skin laxity in 63.6% of subjects. No change was detected in 54.5% of subjects with BMI >30 kg/ m2 vs. 12.2% of subjects with BMI ≤30 kg/m2. At day 90, 65.6% of subjects perceived improvement in the skin laxity of the lower half of their face and neck. The effect of dual-depth MFU-V is also very durable. Following a single dualdepth treatment of the face and upper-neck treatment using 4 MHz/4.5 mm and 7  MHz/3.0 mm transducers, the proportion of subjects showing any level of improvement based on investigator assessment at 90 days (N=16) and 180 days (N=45) was 81.3% and 77.7%, respectively. The proportion of subjects that believed they demonstrated improvement in appearance was 75% and 77.8% at 90 days and 180 days, respectively23. Dual-depth treatment with vectoring A recent study evaluated the use of dual depth MFU-V for lifting and tightening facial and neck skin with the addition of vertical vectoring and by increasing the number of treatment lines24. In one group of subjects (N=107), dual-depth MFU-V was administered as follows: ■■ 7 MHz/3.0 mm and 7 MHz/4.5 mm (15 lines, 423 J each) to each lateral brow and crow’s feet ■■ 7 MHz/3.0 mm and 4 MHz/4.5 mm (15 lines, 461.2 J each) to each malar bag ■■ 7 MHz/3.0 mm and 4 MHz/4.5 mm (60 lines, 1845 J each) to each half of the face ■■ 7 MHz/3.0 mm and 4 MHz/4.5 mm (75 lines, 2306 J each) to the entire neck.

The fibromuscular layer and dermal treatment lines above the superolateral brow were treated in vertical directions but administered horizontally within crow’s feet sites. The fibromuscular and dermal treatment lines within the malar bag site were placed in a superomedial direction. Fibromuscular treatment lines in the face and neck were positioned in a horizontal direction, and dermal treatment lines were placed superolaterally. In another group (N=55), subjects received twice as many MFU-V treatment lines and therefore twice the total energy as the first group except the malar bag area which remained unchanged: ■■ 7 MHz/3.0 mm and 7 MHz/ 4.5 mm (30 lines, 847 J) to each lateral brow and crow’s feet ■■ 7 MHz/3.0 mm and 4 MHz/4.5 mm (15 lines, 461.2 J) to each malar bag ■■ 7 MHz/3.0 mm and 4 MHz/4.5 mm (120 lines, 3690 J) to each half of the face ■■ 7 MHz/3.0 mm and 4 MHz/4.5 mm (150 lines, 4612 J each) to the entire neck. Three months after treatment, two blinded evaluators determined 51.4% of patients in the first group (fewer lines, lower energy) were responders (mild: 47.2%, moderate: 52.8%) increasing to 70.3% (mild: 31.1%, moderate: 68.9%) at 6 months. In contrast, 71.2% of patients in the second group (more lines, higher energy) were responders at 3 months (mild: 34.0%, moderate: 47.6%, significant: 18.4%) increasing to 80.2% (mild: 10.4%, moderate: 63.4%, significant: 26.2%) at 6 months.

Efficacy of MFU-V for lifting lax skin on the periorbitum MFU-V has also been used for noninvasive eyelid rejuvenation. In one study, subjects with infraorbital laxity (N=15) received one treatment with a single depth of MFU-V applied to the periorbital area using a 7.0 MHz/3.0 mm transducer25. After 6 months, blinded evaluator assessment indicated 13.33% were much improved, 73.33% were improved and 13.33% were unchanged. Treated subjects rated themselves as much improved (20.0%) and improved (80.0%). The effects of a single treatment using dual levels of MFU-V applied to the periorbital area were also assessed in subjects with mild-to-moderate crepey skin outside the orbital rims and mild-to-moderate skin ptosis (N=19)4. MFU-V was applied using 7 MHz/3.0 mm and 19 MHz/1.5 mm transducers across the upper lid-brow complex, lateral canthal area, and below the lower lid margin. To prevent intraocular injury, dual depth treatment was limited to tissue over the orbital portion of the orbicularis muscle and bone. After 6 months, the single dual-depth treatment of MFU-V resulted in a mean brow elevation 1.7 mm. This compares favorably with treatment using radiofrequency which raised brow

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| 90, 100% were improved by subject assessment and 96% were improved by physician assessment. At day 180, 95.2% of subjects were either satisfied (52%) or very satisfied (43%) with the results they achieved.

Efficacy of MFU on other anatomical areas Although not cleared for these uses, MFU-V has also been used to non-invasively lift and tighten lax skin in other anatomical areas including the upper arms4,28, elbows29, thighs4,28, knees4,28,30, and buttocks4,31. Similar to areas of the face, neck, and décolleté, single- and dual-plane treatment of these areas with MFU-V also resulted in significant improvements in global assessment scores that in some cases continued to improve between 3 and 6 months following treatment28 and persisted for 6 to 18 months4,29–31.

Safety

Face and neck

height a mean of 1.30–1.49 mm26. Based on global investigator and subject assessments, improvements in wrinkled and crepey skin were observed as early as 6 weeks becoming more appreciable between 3 and 6 months. These improvements were maintained from 6 to 18 months.

Efficacy of MFU-V on the décolletage The beneficial effect of MFU-V for treating the décolleté area was initially assessed in a pilot study with five women using 7 MHz/3.0 mm and 10 MHz/1.5 mm transducers4. Improvements in wrinkled and crepey skin was observed as early as 6 weeks with maximum smoothing and tightening occurring between 3 to 6 months and lasting from 6 to 18 months. To assess its efficacy on the décolleté in a larger population, 120 lines of MFU-V was first administered using the 4 MHz/4.5 mm transducer followed by 120 lines using the 7 MHz/3.0 mm transducer (dual depth)27. Rhytids improved over time, with 46% and 62% of subjects showing a 1- to 2-point improvement at days 90 and 180, respectively, based on a 5-point numeric rating system. Mean (SD) mid-clavicular to nipple distance significantly decreased from 20.9 (1.57) cm at baseline to 19.8 (1.50) cm and 19.5 (1.59) cm, at days 90 and 180, respectively. At day

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In all published studies, MFU-V has been reported to be very well tolerated. Most patients receive oral nonsteroidal anti-inflammatory or opiate medication prior to treatment and occasionally with topical lidocaine13,23. Based on an 11-point (0–10) numeric rating system where 0 denotes no pain and 10 denotes worst imaginable pain, mean pain severity scores during treatment of the face and neck are typically 3 to 418,21,24 and occasionally as high as 718,21. One study reported mean pain scores for the cheek, Treatment-related submental, and submandibular adverse events are generally regions of 225.68, 6.09, and 6.53, . Treatment-related mild or moderate in severity, respectively discomfort ceases immediately transient in duration, and most when the procedure has ended. often consist of local Discontinuation of treatment due erythema, edema and to pain or discomfort is rare. MFU-V appears to be safe across all skin bruising. types. Its safety has been demonstrated in Korean subjects with Fitzpatrick skin type III–VI19 and subjects in India with skin types III-VI32. Treatment-related adverse events are generally mild or moderate in severity, transient in duration, and most often consist of local erythema13,18,19,21,24,33, edema17-19,21,24,25,33 and bruising17,24,25,33. Other uncommon adverse events have included dysesthesia (N=7)19,24, elevated white linear striations or wheals (N=8)18,19,22, post-inflammatory hyperpigmentation (N=2)33, skin papule (N=1)23, and perioral numbness with partial paralysis (N=1)34. In one report, the occurrence of striations was believed to be caused by improper coupling of the transducer with the skin19. In one report, such striations lead to scar formation17. No serious adverse events or events of a systemic nature have ever been reported.

Décolleté When used to treat the décolleté area, mean treatmentrelated pain scores ranged from approximately 5 to 627. The most common adverse events were mild and transient tenderness (47.4%), bruising (23.2%) pruritis

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| skin tightening | peer-review (16.8%) and edema (4.2%)27. One event of bruising was of moderate severity and resolved in 20 days.

Other areas Although some subjects experienced transient adverse events including erythema and skin tenderness28, most subjects treated on the upper arms, elbows, thighs, knees, and buttocks experienced no treatment-related adverse events29–31.

Discussion

Patient selection

heated to >60°C at the thermal injury zone where collagen in the superficial musculoaponeurotic system undergoes thermal coagulation. Techniques for achieving skin lift and tightening with MFU-V are continuously undergoing change and refinement and off-label use has grown to include treatment of the upper arms, elbows, thighs, knees, and buttocks. Most clinical studies do not have follow-up beyond 180 days, but in the author’s experience meaningful results have been seen in patients for up to 3 years after a single treatment. MFU-V very well tolerated with most patients reporting mild or moderate treatment discomfort. Treatmentrelated adverse events are generally mild or moderate in severity, transient in duration and most often consist of local erythema, edema and bruising. No serious adverse events or events of a systemic nature have ever been reported.

The ideal patient has mild to moderate skin laxity and mild lipoptosis35. Since the effects of MFU-V are caused by a wound healing response, younger subjects generally have better clinical outcomes than older subjects35. Similarly, Since the effects of MFU-V subjects with extensive sun are caused by a wound healing damaged skin are less likely to Declaration of interest Sabrina achieve effects as good as G. Fabi received no funding for the response, younger subjects those with healthy skin. Clinical preparation of this manuscript. generally have better outcomes may also not be as clinical outcomes than good for obese subjects (BMI Declaration of financial 2 22 older subjects. >30 kg/m ) . There is little relationships Sabrina G. Fabi serves as an investigator, evidence of an association between improvement and age, alcohol intake or major consultant, and speaker for Ultherapy. She also has served illness23. To ensure patient satisfaction, it is also important on the advisory board and has been a consultant for to choose patients with realistic expectations of Valeant and Merz. She serves as a trainer and speaker for Allergan and Lumenis. treatment outcomes.

Conclusion An FDA-cleared MFU-V device is currently indicated for use as a non-invasive dermatological aesthetic treatment to lift the eyebrow, lax submental and neck tissue, and to improve lines and wrinkles of the décolleté. A series of four transducers deliver high-intensity focused ultrasound to the selected focal depth where tissue is

Acknowledgements The author acknowledges the editorial assistance of Dr. Carl Hornfeldt during the preparation of this manuscript.

Key points Micro-focused ultrasound with visualization (MFU-V) is the only non-invasive treatment cleared by the FDA to lift the eyebrow, lax submental and neck tissue, and improve lines and wrinkles of the décolleté The device is also capable of ultrasound imaging of the treatment area to confirm appropriate treatment depth and avoid non-target tissues The aesthetic improvements can persist for up to 18 months, demonstrating the durable nature of MFU-V treatment Younger subjects with mild to moderate skin laxity and mild lipoptosis generally have better clinical outcomes than older subjects while obese subjects or those with extensive sun damaged skin are less likely to achieve benefit Common adverse events include local mild and transient paresthesias, erythema, and edema. MFU-V is safe to use on all Fitzpatrick skin types

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live farm pig. Dermatol Surg 1999; 25:851-6 9. Ross EV, Naseef GS, McKinlay JR, et al. Comparison of carbon dioxide laser, erbium:YAG laser, dermabrasion, and dermatome: a study of thermal damage, wound contraction, and wound healing in a live pig model: implications for skin resurfacing. J Am Acad Dermatol 2000; 42:92-105 10. White WM, Makin IR, Slayton MH, Barthe PG, Gliklich R. Selective transcutaneous delivery of energy to porcine soft tissues using Intense Ultrasound (IUS). Lasers Surg Med 2008; 40:67-75 11. White WM, Makin IR, Barthe PG, Slayton MH, Gliklich RE. Selective creation of thermal injury zones in the superficial musculoaponeurotic system using intense ultrasound therapy: a new target for noninvasive facial rejuvenation. Arch Facial Plast Surg 2007; 9:22-9 12. Laubach HJ, Makin IR, Barthe PG, Slayton MH, Manstein D. Intense focused ultrasound: evaluation of a new treatment modality for precise microcoagulation within the skin. Dermatol Surg 2008; 34:727-34 13. Gliklich RE, White WM, Slayton MH, Barthe PG, Makin IR. Clinical pilot study of intense ultrasound therapy to deep dermal facial skin and subcutaneous tissues. Arch Facial Plast Surg 2007; 9:88-95 14. ULTHERA® Operation & Maintenance

Manual. Ulthera, Inc., Mesa, AZ. 15. MacGregor JL, Tanzi EL. Microfocused ultrasound for skin tightening. Semin Cutan Med Surg 2013; 32:18-25 16. Ultherapy® Treatment Guideline (5.0 PLUS). Ulthera, Inc., Mesa, AZ 17. Sabet-Peyman EJ, Woodward JA. Complications using intense ultrasound therapy to treat deep dermal facial skin and subcutaneous tissues. Dermatol Surg 2014; 40: 1108-12 18. Alam M, White LE, Martin N, Witherspoon J, Yoo S, West DP. Ultrasound tightening of facial and neck skin: a rater-blinded prospective cohort study. J Am Acad Dermatol 2010; 62:262-9 19. Suh DH, Shin MK, Lee SJ, et al. Intense focused ultrasound tightening in Asian skin: clinical and pathologic results. Dermatol Surg 2011; 37:1595-602 20. Baumann L, Zelickson B. Evaluation of micro-focused ultrasound for lifting and tightening neck. Derm Surg In press 21. Lee HS, Jang WS, Cha YJ, et al. Multiple pass ultrasound tightening of skin laxity of the lower face and neck. Dermatol Surg 2012; 38:20-7 22. Oni G, Hoxworth R, Teotia S, Brown S, Kenkel JM. Evaluation of a microfocused ultrasound system for improving skin laxity and tightening in the lower face. Aesthet Surg J 2014; Jul 2:[Epub ahead of print]. 23. Fabi SG, Goldman MP. Retrospective

evaluation of micro-focused ultrasound for lifting and tightening the face and neck. Dermatol Surg 2014; 40:569-75 24. Sasaki GH, Tevez A. Clinical efficacy and safety of focused-image ultrasonography: a 2-year experience. Aesthet Surg J 2012; 32:601-12 25. Suh DH, Oh YJ, Lee SJ, et al. A intense-focused ultrasound tightening for the treatment of infraorbital laxity. J Cosmet Laser Ther 2012; 14:290-5 26. Fitzpatrick R, Geronemus R, Goldberg D, Kaminer M, Kilmer S, Ruiz-Esparza J. Multicenter study of noninvasive radiofrequency for periorbital tissue tightening. Lasers Surg Med 2003; 33:232-42 27. Fabi SG, Massaki A, Eimpunth S, Pogoda J, Goldman MP. Evaluation of microfocused ultrasound with visualization for lifting, tightening, and wrinkle reduction of the décolletage. J Am Acad Dermatol 2013; 69:965-71 28. Alster TS, Tanzi EL. Noninvasive lifting of arm, thigh, and knee skin with transcutaneous intense focused ultrasound. Dermatol Surg 2012; 38:754-9 29. Rohksar C, Schneblen W. A prospective, single-center study of the efficacy and safety of micro-focused ultrasound with visualization for the non-invasive treatment of skin wrinkles and laxity above the elbow. Lasers Surg Med 2013; 45:1-93 30. Gold MH. A prospective, single-center

study of the efficacy and safety of micro-focused ultrasound with visualization for the non-invasive treatment of skin wrinkles and laxity above the knee. Presented: Annual meeting of the American Society for Dermatologic Surgery, Atlanta, GA; October 11-14, 2012 31. Goldberg D, Bard S, Payaongayong L. Micro-focused ultrasound for lifting, tightening, skin laxity of the buttocks. Lasers Surg Med 2013; 45:1-93 32. Nooreyezdan SS, Makin IRS. Aesthetic intense focused ultrasound (IFUS): clinical perspective on Fitzpatrick skin types III-IV. In: Sardana K, Garg VK, eds. Lasers in Dermatologic Practice. 1 ed. London: Jaypee Brothers Medical Publishers, Ltd; 2014:319-35 33. Chan NP, Shek SY, Yu CS, Ho SG, Yeung CK, Chan HH. Safety study of transcutaneous focused ultrasound for non-invasive skin tightening in Asians. Lasers Surg Med 2011; 43:366-75 34. Jeong KH, Suh DH, Shin MK, Lee SJ. Neurologic complication associated with intense focused ultrasound. J Cosmet Laser Ther 2013;Nov 18 [Epub ahead of print] 35. Brobst RW, Ferguson M, Perkins SW. Ulthera: initial and six month results. Facial Plast Surg Clin North Am 2012; 20:163-76

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