Safety and Efficacy of Microfocused Ultrasound in Tightening of Lax Elbow Skin Cameron Rokhsar, MD,* Wendy Schnebelen, BA, Alexandre West, BA,† and Carl Hornfeldt‡

BACKGROUND With the increased popularity of minimally invasive cosmetic treatments, this study evaluates the efficacy and safety of microfocused ultrasound with visualization (MFU-V) for tightening lax skin above the elbow. METHODS Subjects were treated bilaterally above the elbows with MFU-V using transducers with different focal depths. Photographs were taken before treatment and at 90- and 180-day follow-ups. Masked observer ratings and physician and subject global aesthetic improvement scales (PGAIS and SGAIS) were completed at follow-ups. Safety, based on adverse event (AE) incidence, was assessed. RESULTS Masked blinded assessment was completed at 90 days; 56% showed aesthetic improvement. Overall improvement in SGAIS was 83% and 81% at 90 and 180 days, respectively. The overall improvement in PGAIS was 94% at both 90 and 180 days. Patient satisfaction questionnaires showed that 83% noticed improvements in elbow characteristics at 90 days, with 81% still indicating improvement at 180 days. No serious AEs or treatment-related AEs were reported. CONCLUSION This pilot study suggests that MFU-V is a safe and promising nonsurgical option for the treatment of skin laxity above the elbow. Based on the positive results of this study, a larger trial is warranted together with testing different treatment densities to optimize this noninvasive approach. The authors have indicated no significant interest with commercial supporters.

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none of these technologies have been used to reduce the appearance of lax or sagging skin above the elbow.

Several noninvasive devices have been developed to tighten the skin on the upper arm including microfocused ultrasound with visualization (MFU-V)9 and radiofrequency,10,11 low-level laser therapy,12 and a combination of bipolar radiofrequency, infrared energy, vacuum, and mechanical massage13; however,

A device that emits microfocused ultrasound (MFU) has been developed for nonablative skin lifting and tightening.14 By targeting highly focused ultrasound energy in discrete areas within dermal and subdermal tissues, MFU causes discrete thermal coagulation points while sparing adjacent nontarget tissues.15,16 Within these small (1 mm3) areas of thermal tissue coagulation, the denatured collagen shrinks, de novo collagenesis is stimulated, and new viscoelastic collagen forms, resulting in the lifting and tightening of lax skin.17 This MFU device is also capable of high-resolution ultrasound imaging (MFU-V), which enables visualization of tissue planes to a depth of 8 mm and allows the user to see

here is an increasingly growing demand for less invasive methods for improving body appearance including the arms. Currently, liposuction is used for removing unwanted adipose tissue from upper arms,1–3 and brachioplasty is used for removing excess loose skin from the upper arms after substantial weight loss.4–6 These methods are used either alone or in combination.7,8 Both are invasive approaches, which require downtime.

*Assistant Professor of Dermatology, Mount Sinai Hospital System, New York, New York; †New York Cosmetic, Skin and Laser Surgery Center, New York, New York; ‡Saint Paul, Minnesota Supported by Ulthera. Editorial assistance was provided by Carl Hornfeldt who was compensated by Ulthera. © 2015 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved. ISSN: 1076-0512 Dermatol Surg 2015;41:821–826 DOI: 10.1097/DSS.0000000000000390

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ULTRASOUND IN TIGHTENING OF LAX ELBOW SKIN

where the MFU energy will be applied. Ultrasound imaging also ensures that there is acoustic coupling between the skin and transducer before applying MFU.

TABLE 1. Demographic Characteristics of Enrolled Subjects N (%)

Numerous studies have demonstrated the safety and effectiveness of MFU-V as a noninvasive aesthetic treatment to lift eyebrows and lax facial tissue.18–23 Recent studies have also demonstrated the effectiveness of MFU-V for noninvasive lifting of skin on the arms, thighs, and knees.9,24 The goal of this prospective open-label clinical trial was to evaluate the safety and effectiveness of MVU-V for lifting, tightening, and improving the aesthetic appearance of lax skin in the area above the elbow. Methods Subjects This study enrolled healthy women who were 21 to 65 years of age and who expressed interest in undergoing treatment for mild to moderate elbow skin laxity. Each enrolled subject agreed to comply with all protocol requirements for the duration of the study. Women of childbearing potential were required to provide a negative urine pregnancy test and agreed to use an acceptable method of birth control during the study. Lactating women were not enrolled. Reasons for exclusion from the study included any illness, condition, or drug therapy that might affect wound healing; excessive skin laxity or subcutaneous fat around the elbows; significant scarring, open wounds, or the presence of a metal implant in the areas to be treated; body mass index $30 kg/m2; a history of chronic drug or alcohol abuse; previous skin-tightening procedures in the proposed treatment area during the past year; or current enrollment in another study involving the use of an investigational device or drug.

Female gender, N (%) Mean age (min–max), years Mean body mass index (min–max), kg/m2

20 (100) 54 (35–65) 23.2 (17.8–29.2)

Race, N (%) Caucasian Asian

19 (95) 1 (5)

Fitzpatrick skin types, N (%) II

19 (95)

III

1 (5)

4.5 mm transducer, followed by a 7 MHz transducer having a focal depth of 3.0 mm. Four patients were inadvertently treated with the 7 MHz, 4.5 mm and 4 MHz, 4.5 mm transducers and did not receive treatment at the 3.0 mm depth. Each transducer was used to deliver 20 lines per square (120 lines of MFU to each treatment area) or 240 lines per elbow. The maximum length of each treatment line was 25 mm, and the lines were spaced 2 to 3 mm apart. Oral pretreatment medications were administered at the discretion of the physician and the patient and were administered at least 30 minutes before the treatment. Photographs were taken immediately before and after treatment and again at 90 and 180 days using a Nikon 2-dimensional digital imaging system and standard lighting conditions. These images were used to assess treatment efficacy at 90 and 180 days after treatment and safety immediately after treatment. Safety was also assessed at 90 and 180 days. Primary Efficacy Measures The primary outcome measure was the overall lifting and tightening of the elbow skin. This was determined

Procedures During Visit 1, a grid consisting of six 2.5 cm2 areas was applied to the back of the arm directly above the point of the elbow. Before MFU treatment, ultrasound imaging was performed on the treatment area to ensure that there was proper acoustic coupling of the transducer with the skin surface. The area was then treated using a 4.4 MHz transducer with a 4.5 mm depth or a 7 MHz,

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TABLE 2. Blinded Assessments of Aesthetic Improvement N (%) Treated subjects

16 (100)

Improved

9 (56)

Incorrect

3 (19)

No change

4 (25)

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ROKHSAR ET AL

Figure 1. (A–C) Representative results 90 days after treatment using a 7 MHz transducer with a focal depth of 3.0 mm followed by a 4.4 MHz, 4.5 mm or 7 MHz, 4.5 mm transducer. Each transducer was used to deliver 20 lines per square (120 lines of MFU to each treatment area) or 240 lines per elbow. The maximum length of each treatment line was 25 mm, and the lines were spaced 2 to 3 mm apart.

by 3 blinded reviewers who were qualified physicians. Each reviewer made qualitative comparisons of images of the treated elbows obtained at baseline and 90 days after treatment. If the reviewer perceived an improvement, they were asked to select the correct post-treatment photograph.

Secondary Efficacy Measures Secondary measures included Global Aesthetic Improvement Scale scores by the principal investigator (PGAIS) and treated subjects (SGAIS), which assessed overall aesthetic improvement at 90 and 180 days.

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ULTRASOUND IN TIGHTENING OF LAX ELBOW SKIN

Patient satisfaction was measured using a Patient Satisfaction Questionnaire at 90 and 180 days.

(Table 2), after being showed before and after pictures of the subjects’ elbows (Figure 1A–C).

Safety

Secondary Efficacy

A validated 11-point numerical rating scale was used to measure the mean level of discomfort reported by subjects during treatment, where 0 represented no pain and 10 represented worst imaginable pain.

Based on PGAIS scores, 94% of subjects achieved aesthetic improvement at both 90 and 180 days. The SGAIS scores showed that 83% and 81% of subjects noted improvement in elbow appearance at 90 days and 180 days, respectively (Table 3).

The investigator examined the treated area 30 to 60 minutes after treatment for evidence of acute reactions such as edema or erythema. Subjects were queried about adverse events (AEs) during the 90- and 180-day evaluations, and spontaneous AEs were recorded throughout the study period. Each subject was also queried about changes in concomitant medications, and the treatment site was visually examined.

Among the subjects completing the Patient Satisfaction Questionnaire at the 90-day follow-up visit, 83% indicated that they noticed improvement in elbow characteristics and 72% indicated that they were very satisfied or satisfied with the aesthetic results they achieved (Table 4). At the 180-day evaluation, 13 of the 16 evaluable subjects (81%) still indicated that they noticed improvement in elbow appearance.

Ethics The study was approved by a Commercial Institutional Review Board (Asentral, Inc. IRB, Newburyport, MA). Each subject provided informed consent and HIPAA authorization before participating in any study-related procedures and provided written consent for use of study-related photography.

Results

Safety There was no evidence of acute skin damage or any long-term sequelae such as scarring, burns, ulceration, or hypopigmentation or hyperpigmentation. There was one AE of hypertension, which was not treatment related. Oral premedications included ibuprofen 400 mg (n = 1) and 800 mg (n = 18) with or without lorazepam

Demographics Twenty female subjects, mean age 54 years (range, 35– 65 years) with a mean BMI of 23.2 kg/m2 (range, 17.8– 29.3 kg/m2), were enrolled and treated with MFU-V. Two failed to return for the 90-day evaluation, and 2 additional subjects did not return for the 180-day follow-up visit. The demographic characteristics of the enrolled subjects are provided in Table 1.

TABLE 3. Global Aesthetic Improvement Score Level of Improvement, N (%)

Day 90 (N = 18)

Day 180 (N = 16)

Very much improved

1 (6)

1 (6)

Much improved

7 (39)

6 (38)

Improved

9 (50)

8 (50)

No change

1 (6)

1 (6)

Physician

Worse

Primary Efficacy Eighteen subjects were available for the 90-day blinded assessment; however, 2 subjects were eliminated because of poor quality images caused by inconsistent lighting. Among the remaining 16 subjects, 9 (56%) were determined to show aesthetic improvements in the MFU-V–treated areas by masked assessment

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Any improvement Subject Very much improved Much improved Improved No change Worse Any improvement





17 (94)

15 (94)





5 (28)

5 (31)

10 (56)

8 (50)

3 (17)

3 (19)





15 (83)

13 (81)

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TABLE 4. Patient Satisfaction Satisfaction, N (%)

Very Satisfied

Satisfied

Dissatisfied

Very Dissatisfied

Day 90 (N = 18)

2 (11)

11 (61)

5 (28)



Day 180 (N = 16)



8 (50)

8 (50)



2 mg (n = 12). The mean pain score during treatment with the 4 MHz, 4.5 mm transducer was 5.7, and during treatment with the 7 MHz, 3.0 mm, transducer, the mean pain score was 5.0.

Discussion This is the first study to evaluate the safety and efficacy of MFU in the treatment of lax elbow skin. The MFU-V system is currently FDA cleared to noninvasively lift the eyebrow and lax tissue on the neck and the submental areas14; however, small pilot studies have previously demonstrated the effectiveness of MFU-V for improving the appearance of upper arms, knees, and thighs by tightening lax or sagging skin.9,24 Most of the MFU-V– treated patients in this study achieved improvement in skin laxity above the elbows, which corresponded with a high degree of patient satisfaction. Similar to previous studies on other body areas, the beneficial effects of MFU-V on lax elbow skin persisted for at least 180 days. Masked assessment results suggested more modest improvements than other outcome measures; however, masked assessments were difficult because of challenges with standardizing photography for this treatment area. There were no treatment-related AEs. Although the overall results of this study are positive, the assessment of the effectiveness of this treatment remains limited by certain factors. The most obvious limitation of this study is the sample size. As a pilot study enrolling only 20 patients, the power of this study is inherently low. It is difficult to estimate global success based off of the results in 20 participants. However, the positive results of this study encourage its repetition with a larger sample size. Another difficulty in conducting this study comes from the nature of the skin above the elbow. Estimation of skin tightening from nonsurgical procedures is always difficult, as the results will never be as dramatic as

surgery. This anatomic area has its own particular challenges. To begin with, the reason the skin above the elbows is especially lax compared with other areas of the body is the constant and repetitive motion of the elbow, which constantly stretching the skin in this area. Every time a person moves their lower arm, the skin above their elbow is pulled. It is this constant pulling that causes laxity. This is still true after having received treatment. Although the MFU is delivering its stimulus to tighten skin in the area, the continuous motion of elbows in everyday life serves to increase the laxity of the area. Most likely, the results of this study would have been more promising if not for the countering effects of the motion that is inherent to the area of the elbow. Nonetheless, that the results were favorable. Microfocused ultrasound appears to be a promising approach in treatment of lax skin around the elbows. The positive results in this study beg further investigation with larger sample sizes. In addition, higher treatment densities may produce more dramatic results. Conclusion The results of this study suggest that the MFU-V system can be used safely and effectively to noninvasively improve skin laxity of the elbows.

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6. Hurwitz DJ, Jerrod K. L-brachioplasty: an adaptable technique for moderate to severe excess skin and fat of the arms. Aesthet Surg J 2010; 30:620–9.

17. 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.

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Address correspondence and reprint requests to: Cameron Rokhsar, MD, New York Cosmetic, Skin and Laser Surgery Center, 328 East 75th Street, Suite A, New York, NY 10021, or e-mail: [email protected]

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Safety and Efficacy of Microfocused Ultrasound in Tightening of Lax Elbow Skin.

With the increased popularity of minimally invasive cosmetic treatments, this study evaluates the efficacy and safety of microfocused ultrasound with ...
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