Simultaneous Application of High-Intensity Focused Electromagnetic and Synchronized Radiofrequency for Fat Disruption: Histological and Electron Microscopy Porcine Model Study.

BACKGROUND: Radiofrequency (RF) and high-intensity focused electromagnetic (HIFEM) technologies are used for noninvasive body shaping as standalone modalities. OBJECTIVE: To examine the effects of novel synchronized RF and HIFEM on subcutaneous adipose tissue in a porcine animal model. MATERIALS AND METHODS: Seven large white pigs aged 6 months received 3 abdominal treatments of simultaneous application of synchronized RF and HIFEM (30 minutes, once per week). Punch biopsies of treated and control subcutaneous tissue were collected at the baseline, 4 days, 2 weeks, 1 month, and 2 months. Specimens were examined by light and scanning electron microscopy. Adipocyte volume was analyzed. Fat tissue temperature was measured in situ (fiber optic probes) and superficially (thermal imager). RESULTS: Fat layer was heated to temperatures of 42 to 45°C. Signs of fat apoptosis (shape alternations and pyknotic nuclei) appeared at day 4 and peaked between 2 weeks and 1 month. Adipocyte volume decreased significantly (p < .001) by 31.1% at 2 weeks, 1 month (-23.6%), and 2 months (-22.0%). Control samples showed healthy adipocytes. Scanning electron microscopy micrographs corroborated histology findings, showing flattened, volume-depleted and disrupted adipocytes. CONCLUSION: Synchronized RF with HIFEM procedure resulted in a significant and sustained fat reduction with no adverse events.

1060 nm Diode Hyperthermic Laser Lipolysis:The Latest in Non-Invasive Body Contouring.

Non-invasive body contouring is becoming increasingly popular in the United States. Using the 1060 nm diode laser to achieve hyperthermic temperatures within the adipose tissue with subsequent lipolysis is one of the most recent advancements in this field and is the first of its kind. This wavelength was carefully chosen to effectively target the unwanted adipocytes while sparing the overlying skin and adnexae. Appreciable results are achieved after a single treatment, and these results are comparable to other non-invasive technologies. The 25-minute procedure is well tolerated among patients, with no downtime required. This versatile system allows for treatment of multiple body sites, which can be customized for a particular patient's needs. Herein, we discuss in detail the mechanism of action, efficacy, and safety of 1060 nm diode hyperthermic laser lipolysis. Amongst the various body contouring modalities available today, the 1060 nm diode hyperthermic laser is a worthy addition providing a safe, quick, and effective non-invasive fat reduction option for patients. J Drugs Dermatol. 2017;16(1):48-52..

Subcutaneous adipose tissue response to a non-invasive hyperthermic treatment using a 1,060 nm laser.

BACKGROUND: We postulated that a hyperthermic treatment using a 1,060 nm laser can cause a controlled adipocyte injury resulting in non-invasive fat reduction. This three-part study identified treatment parameters for a safe and tolerable treatment, demonstrated short- and long-term tissue response, and assessed the potential of this treatment for non-invasive fat reduction. METHODS: In vivo temperature measurements were conducted prior to abdominoplasty via a thermal camera (for surface readings) and thermocouple needle (for subcutaneous readings). Short- and long-term tissue response was evaluated on the abdomen immediately post to 6 months post a 1,060 nm laser treatment. Laser dosage was varied to identify safe and effective parameters for fat reduction. Tissue biopsies for hematoxylin/eosin (H&E) staining were taken at weeks 1 and 2, as well as at 1, 2, 3, and 6 months (if applicable). Additionally, six subjects received a hyperthermic laser treatment to the flanks; four patients receiving laser treatment to one flank and cryolipolysis on the other, and two patients receiving laser treatment on one side with the other side as an untreated control. Efficacy measurements included ultrasound measurement of fat thickness at baseline, 2, 3, and 6 months; Magnetic Resonance Imaging (MRI) to calculate fat volume at baseline, 3 and 6 months; and blinded photograph evaluation at baseline, 1, 2, 3, and 6 months. RESULTS: In vivo temperature measurements demonstrated that the hyperthermic temperature target (42-47°C) can be achieved and maintained in subcutaneous adipose tissue via a 1,060 nm laser in conjunction with surface cooling. Short- and long-term tissue responses were evaluated by tissue histology up to 6 months following treatment. Histological changes included inflammation, followed by macrophage infiltration starting at approximately 2 weeks, with evacuation of cellular debris completed by approximately 6 months. Clinical results demonstrated average fat thickness reduction at 14%, 18%, and 18% at 2, 3, and 6 months, respectively. Average fat volume reduction measured by MRI at 3 and 6 months was 24% and 21%, respectively. Blinded photo evaluation showed improvement starting at 1-month post-treatment and was maintained at 6 months. Adverse events were rare and included mild tenderness that resolved by 1-week post-treatment. CONCLUSION: Parameters were identified that selectively injure and reduce adipocytes in subcutaneous tissue using a 1,060 nm externally applied laser. The treatment had an excellent safety profile and was well tolerated. The clinical study demonstrated that a 1,060 nm hyperthermic laser treatment for non-invasive fat reduction can be safe and effective. Lasers Surg. Med. 49:480-489, 2017. © 2016 Wiley Periodicals, Inc.

Low-level laser therapy (LLLT) does not reduce subcutaneous adipose tissue by local adipocyte injury but rather by modulation of systemic lipid metabolism.

Low-level laser (light) therapy (LLLT) has been applied recently to body contouring. However the mechanism of LLLT-induced reduction of subcutaneous adipose tissue thickness has not been elucidated and proposed hypotheses are highly controversial. Non-obese volunteers were subject to 650nm LLLT therapy. Each patient received 6 treatments 2-3 days apart to one side of the abdomen. The contralateral side was left untreated and served as control. Subjects' abdominal adipose tissue thickness was measured by ultrasound imaging at baseline and 2 weeks post-treatment. Our study is to the best of our knowledge, the largest split-abdomen study employing subcutaneous abdominal fat imaging. We could not show a statistically significant reduction of abdominal subcutaneous adipose tissue by LLLT therapy. Paradoxically when the measurements of the loss of fat thickness on treated side was corrected for change in thickness on non treated side, we have observed that in 8 out of 17 patients LLLT increased adipose tissue thickness. In two patients severe side effect occurred as a result of treatment: one patient developed ulceration within appendectomy scar, the other over the posterior superior iliac spine. The paradoxical net increase in subcutaneous fat thickness observed in some of our patients is a rationale against liquefactive and transitory pore models of LLLT-induced adipose tissue reduction. LLLT devices with laser diode panels applied directly on the skin are not as safe as devices with treatment panels separated from the patient's skin.

Male Body Contouring.

Men are increasingly turning to dermatologists and plastic surgeons to request procedures that correct or enhance physical features. With the advent of this emerging new patient population, alterations in preexisting aesthetic techniques, gender-specific uses of existing devices and overall approaches need to be revisited and adapted to obtain results that are suitable for the male patient. Recently, body contouring has become one of the most sought out procedures by men. Although the majority of clinical studies involving body contouring esthetics are performed with female patients, gains from such studies can be extrapolated to men. Body contouring can be broadly classified as non-invasive or invasive, depending on the modality used. Non-invasive contouring is most frequently performed with devices that target subcutaneous adipose with focused electrical or thermal energy, including low-level laser, cryolipolysis, ultrasonography, and radiofrequency. Invasive body contouring modalities useful for male body contouring include liposuction, pectoral and abdominal wall etching, jawline fillers, synthetic deoxycholic acid injections, and solid silicone implants. The purpose of this review is to bring attention to the unique aspects, strategies, and modalities used in aesthetic body contouring for the male patient.

Preliminary demonstration using localized skin temperature elevation as observed with thermal imaging as an indicator of fat-specific absorption during focused-field radiofrequency therapy.

BACKGROUND: This study incorporates concurrent thermal camera imaging as a means of both safely extending the length of each treatment session within skin surface temperature tolerances and to demonstrate not only the homogeneous nature of skin surface temperature heating but the distribution of that heating pattern as a reflection of localization of subcutaneous fat distribution. METHODS: Five subjects were selected because of a desire to reduce abdomen and flank fullness. Full treatment field thermal camera imaging was captured at 15 minute intervals, specifically at 15, 30, and 45 minutes into active treatment with the purpose of monitoring skin temperature and avoiding any patterns of skin temperature excess. RESULTS: Peak areas of heating corresponded anatomically to the patients' areas of greatest fat excess ie, visible "pinchable" fat. CONCLUSION: Preliminary observation of high-resolution thermal camera imaging used concurrently with focused field RF therapy show peak skin heating patterns overlying the areas of greatest fat excess.

Superficial heat reduction technique for a hybrid microwave-optical device.

Microwave applicator in the form of a circularly polarized microstrip patch antenna is proposed to provide localized deep heating in biological tissue, which causes blood vessels to dilate leading to changes in tissue oxygenation. These changes are monitored by an integrated optical system for studying thermoregulation in different parts of the human body. Using computer simulations, this paper compares circularly and linearly polarized antennas in terms of the efficiency of depositing electromagnetic (EM) energy and the heating patterns. The biological model composes of the skin, fat and muscle layers with appropriate dielectric and thermal properties. The results show that for the same specific absorption rate (SAR) in the muscle, the circularly polarized antenna results in a lower SAR in the skin-fat interface than the linearly polarized antenna. The thermal distribution is also presented based on the biological heat equation. The proposed circularly polarized antenna shows heat reduction in the superficial layers in comparison to the linearly polarized antenna.

Low-level laser therapy for fat layer reduction: a comprehensive review.

BACKGROUND AND OBJECTIVE: Low-level laser (light) therapy (LLLT) is a noninvasive, nonthermal approach to disorders requiring reduction of pain and inflammation and stimulation of healing and tissue regeneration. Within the last decade, LLLT started being investigated as an adjuvant to liposuction, for noninvasive body contouring, reduction of cellulite, and improvement of blood lipid profile. LLLT may also aid autologous fat transfer procedures by enhancing the viability of adipocytes. However the underlying mechanism of actions for such effects still seems to be unclear. It is important, therefore, to understand the potential efficacy and proposed mechanism of actions of this new procedure for fat reduction. MATERIALS AND METHODS: A review of the literature associated with applications of LLLT related to fat layer reduction was performed to evaluate the findings from pre-clinical and clinical studies with respect to the mechanism of action, efficacy, and safety. RESULTS: The studies as of today suggest that LLLT has a potential to be used in fat and cellulite reduction as well as in improvement of blood lipid profile without any significant side effects. One of the main proposed mechanism of actions is based upon production of transient pores in adipocytes, allowing lipids to leak out. Another is through activation of the complement cascade which could cause induction of adipocyte apoptosis and subsequent release of lipids. CONCLUSION: Although the present studies have demonstrated safety and efficacy of LLLT in fat layer reduction, studies demonstrating the efficacy of LLLT as a stand-alone procedure are still inadequate. Moreover, further studies are necessary to identify the mechanism of action.

Methods for the assessment of the efficacy of products and slimming treatments for cellulite according to the Italian Interdisciplinary Group for the standardization of efficacy tests on cosmetic products.

Cellulite is a very common skin alteration with a complex pathogenesis; different degrees of severity of cellulite can be observed in most part of people after puberty, and numerous cosmetic or more invasive treatments have been proposed, with variable efficacy. Since reproducible methods of evaluation of the effectiveness of cellulite treatments are lacking, the purpose of our group was to define and set general testing principles for evaluating the efficacy of slimming products and treatments/remodeling methods for cellulite, to achieve a delineation of reliable and reproducible research steps following a well-designed and scientifically valid methodology. After a careful review of literature and textbooks and according to personal experience, we defined assessment protocols based on clinical and instrumental tools. In order to make studies reliable, reproducible and safe, a protocol standardization is needed. The sponsor is responsible for assuring quality and information concerning the product under investigation; moreover, investigators should be experienced on cellulite evaluation and treatment, and, finally, the duration and modalities of application of the product should be specified. A treated VS non treated area comparison can be performed, to evaluate the severity of cellulite and the clinical outcomes of the treatment. Besides clinical evaluation, instrumental methods should always be implemented to provide objective data for treatment outcome.

A multicenter study for a single, three-step laser treatment for cellulite using a 1440-nm Nd:YAG laser, a novel side-firing fiber, and a temperature-sensing cannula.

BACKGROUND: Historically, treatments for cellulite have not been able to address all of its physiological components and require multiple sessions. OBJECTIVE: The authors evaluate the safety and efficacy of a single, subdermal procedure to treat the underlying structure of cellulite. METHODS: Fifty-seven patients underwent a 3-step cellulite treatment with a 1440-nm Nd:YAG laser with a side-firing fiber and temperature-sensing cannula. Efficacy was measured by the ability of blinded evaluators to distinguish baseline photos from those taken at 3 and 6 months posttreatment, as well as their rating of the results on a 5-point, 2-category ordinal photonumeric scale when comparing baseline photos to those taken at 2, 3, and 6 months posttreatment. Patient and physician satisfaction was assessed based on completion of a satisfaction survey at 2, 3, and 6 months posttreatment. Adverse events (AE) were recorded throughout the study. RESULTS: At 6 months posttreatment, blinded evaluators rated at least a 1-point improvement in the appearance of cellulite in 96% of treated sites. Blinded evaluators were also able to correctly identify baseline versus posttreatment photos in 95% of cases. At least 90% of patients and physicians reported satisfaction with the results of treatment throughout 6 months. AE were mild in intensity and transient to treatment. CONCLUSIONS: A single, 3-step, minimally invasive laser treatment using a 1440-nm Nd:YAG laser, side-firing fiber, and temperature-sensing cannula to treat the underlying structure of cellulite proved to be safe and maintained effectiveness at least 6 months posttreatment. LEVEL OF EVIDENCE: 2.

Cellulite - an overview of non-invasive therapy with energy-based systems.

Cellulite is one of the most common skin care concerns seen in modern dermatology. The presence of cellulite in the 21(st) century is now considered a major "problem" whose treatment options are varied and numerous, all with hopes of improving the appearance of cellulite and maintaining its response over a period of time. The purpose of this article is to review cellulite, its predisposing factors, its classification, and some of the more common devices now in use to treat the disorder.

Application of low-level laser therapy for noninvasive body contouring.

BACKGROUND: Low-level laser therapy (LLLT) is a noninvasive treatment for a wide-assortment of medical ailments. A recent application is for noninvasive body slimming. A Level 1 clinical study was completed and recorded a significant reduction in circumferential measurements across waist, hips, and thighs compared to placebo subjects. Questions remain unanswered to whether the result observed was based upon simple fluid redistribution. The purpose of this retrospective study was to evaluate the efficacy of LLLT for noninvasive body slimming and determine if the loss was attributable to fluid or fat relocation. METHODS: Data from 689 participants were obtained to evaluate the circumferential reduction demonstrated across the treatment site of the waist, hips, and thighs as well as nontreated systemic regions. Patient data were not pre-selected; all reports provided by clinics using LLLT for body contouring were used to evaluate the efficacy of this treatment. Participants received a total of six LLLT treatments across 2-weeks having baseline and post-procedure circumferential measurements recorded. Measurement sites included waist, hips, thighs, arms, knees, neck, and chest. RESULTS: The mean circumferential reduction reported for the waist, hips, and thighs 1 week after the treatment regimen was 3.27 in. (P < 0.0001). Furthermore, participants demonstrated an overall mean reduction of 5.17 in. across all measurement points 5.17 in. (P < 0.0001). Each anatomical region measured exhibited a significant circumferential reduction. CONCLUSION: These data reveal that the circumferential reduction exhibited following LLLT is not attributable to fluid or fat relocation as all measurement points, including nontreated regions, reported an inch loss.

Improvement in arm and post-partum abdominal and flank subcutaneous fat deposits and skin laxity using a bipolar radiofrequency, infrared, vacuum and mechanical massage device.

BACKGROUND AND OBJECTIVES: Skin laxity of the body is a growing cosmetic concern. Laxity can result from chronological or photoaging and changes in body dimensions during pregnancy or weight loss. The end result is loose, sagging skin, and localized fat deposits. Liposuction and abdominoplasty or brachioplasty are established approaches to these issues. Patient desire for alternatives to surgical correction has spawned the development of non-invasive body contouring devices. The combination of infrared light (IR), bipolar radiofrequency (RF), vacuum and mechanical massage (Velashape, Syneron Medical Ltd, Israel) has demonstrated efficacy in improving skin appearance and circumference of the thighs [Goldberg et al., Derm Surg 2008; 34:204-209; Fisher et al., Derm Surg 2005; 31:1237-1241; Arnoczky and Aksan, J Am Acad Orthop Surg 2000; 8:305-313; Alster and Tanzi, J Cosmetic Laser Therapy 2005; 7:81-85; Wanitphakdeedecha and Manuskiatti, J Cosmet Dermatol 2006; 5:284-288; Nootheti et al., Lasers Surg Med 2006; 38: 908-912], but only anecdotal evidence has supported its use on other anatomic locations. This study was designed to evaluate the efficacy and safety of Velashape on additional body sites and more rigorously examine the technology's impact on upper arm as well as abdominal and flank circumference. STUDY DESIGN AND METHODS: Subjects were 28-70 years old, skin types I-V. Nineteen subjects underwent 5 weekly treatments of the upper arms, and 10 subjects underwent 4 weekly treatments of the abdomen and flanks. Treatments were performed using Velashape. Circumference measurements, photographs, and subject weights were performed prior to treatment and at 1- and 3-month follow-ups. Subjects were asked to record their treatment satisfaction level. RESULTS: Change in arm circumference, at the 5th treatment was statistically significant with a mean loss of 0.625 cm. At 1- and 3-month follow-ups, mean loss was 0.71 and 0.597 cm respectively. Reduction of abdominal circumference at 3rd treatment was statistically significant with a 1.25 cm mean loss. At 1- and 3-month follow-ups, average loss was 1.43 and 1.82 cm respectively. CONCLUSIONS: This study demonstrates with statistical significance, sustainable reduction in circumference and improvement in appearance of arms and abdomen following treatment with Velashape.

Controlled volumetric heating of subcutaneous adipose tissue using a novel radiofrequency technology.

BACKGROUND AND OBJECTIVE: The objective of the present study was to demonstrate the feasibility of varying the size of the heating volume of subcutaneous adipose tissue using a novel radiofrequency (RF) technology that controls the delivered energy distribution on the skin surface. STUDY DESIGN/MATERIALS AND METHODS: Changes in the distribution of the electric potential at the skin surface due to frequency adjustment of a novel RF device were experimentally characterized on human skin at 500 kHz, 1, 2, 3, and 4 MHz. These measurements were used to model RF-induced electric fields and power absorption. Thermal measurements in ex vivo animal models were used to complement the initial mathematical modeling. RESULTS: At 500 kHz the electric potential on the skin surface was nearly constant across the RF applicator surface. At 4 MHz the electric potential dropped 30% from the center to the edge of the RF applicator. At the centerline of the RF applicator, modeling shows that within a 3 cm subcutaneous fat layer the absorbed power at the bottom layer was 40% less than that at the top for 500 kHz. The absorbed power decreased 80% for 4 MHz. Temperature measurements show uniform heating across a horizontal array of probes with 500 kHz. Temperatures were significantly higher at the center probes for 4 MHz. Cross-sectional radiometric temperature maps show a larger heated tissue cross-section using 500 kHz as opposed to 4 MHz. CONCLUSIONS: As the frequency increases (i) the electric potential at the skin surface decreases from the center to the edge of the RF applicator; (ii) the difference between the power absorbed at the top and bottom of the subcutaneous fat layer increases; (iii) the difference between the power absorbed at the center and the periphery of the exposed subcutaneous fat volume also increases; and, consequently, (iv) the size of the heated subcutaneous fat volume decreases. Such a device when used in humans may allow for differential delivery of heat to varying fat thicknesses and anatomic areas.

A study evaluating the safety and efficacy of the VelaSmooth system in the treatment of cellulite.

BACKGROUND: Most cellulite treatments are limited in their effectiveness. A combination of radiofrequency energy, infrared light and mechanical manipulation of the skin and fat merits further examination. OBJECTIVE: Subjects were treated with a device combining these energies to evaluate its safety and efficacy. METHODS: Sixteen subjects with cellulite were treated twice weekly for 6 weeks with the VelaSmooth system. One thigh was treated while the other served as a control. Treatment efficacy was measured through circumferential measurements of both thighs and by having the investigator and an independent evaluator grade visual improvement during follow-up visits. Five patients provided blood specimens for assessment of lipid and hormone levels and liver function. Two subjects provided three biopsies each in order to monitor the level of estrogen and progesterone receptors. RESULTS: The overall thigh circumference decreased in 71.87% of the treated legs. The mean decrease was 0.44 cm of the lower thigh and 0.53 cm of the upper thigh. There was significant visual improvement in cellulite and skin texture. At the final follow-up visit, 50% of subjects had greater than 25% improvement (good be very good). CONCLUSION: This study showed positive results. Future studies employing higher energy levels and additional treatments will likely augment the results of the present study.