Efficacy and Safety of the Micro-insulated Needle Radiofrequency Device for Reduction of Submental Fat.

BACKGROUND: Recently, it has been reported that a micro-insulated needle radiofrequency (RF) system is effective at achieving subcutaneous fat reduction; however, no study has yet applied this technique to reduce submental fat. OBJECTIVE: To evaluate the efficacy and safety of a fractional RF device with a micro-insulated needle to reduce submental fat. MATERIALS AND METHODS: In this prospective, single-blinded, pre-post comparative study, 24 adults with excess submental fat were treated once using a micro-insulated needle RF device. Outcomes included efficacy (submental fat rating by an independent investigator, fat volume quantified with a 3-dimensional camera, and patient satisfaction), assessed 1 and 2 months after the procedure, and safety (adverse events), assessed throughout the study. RESULTS: The patients' Physician-Assisted Submental Fat Rating Scale score significantly decreased after 1 month and further decreased after 2 months. The average volume of submental fat was significantly decreased after 2 months (20.44 ± 5.53 cc to 16.41 ± 4.58 cc, p < .001). Patient satisfaction was high. Transient and mild local skin reactions without long-term sequelae were observed in 4 patients. CONCLUSION: The micro-insulated needle RF device is beneficial for the reduction of submental fat and has tolerable safety profiles. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05517824.

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.

Safety and Efficacy of a Noninvasive 1,060-nm Diode Laser for Fat Reduction of the Flanks.

BACKGROUND: Preliminary reports indicate a hyperthermic diode laser treatment could be a safe and effective method for noninvasive fat reduction using the 1,060-nm wavelength. This wavelength penetrates the skin to heat subcutaneous adipocytes causing cellular disruption, leaving extracellular lipids, and cellular debris to be evacuated naturally by the body. OBJECTIVE: To evaluate the safety and effectiveness of this modality for noninvasive fat reduction of the flanks. MATERIALS AND METHODS: Forty-nine subjects received single laser treatment to 1 flank. Ultrasound images were taken at baseline, follow-up at 6 and 12 weeks after treatment. High-resolution photographs were taken at baseline and 12 weeks after treatment and then evaluated by independent reviewers. Adverse events recorded at all visits. Subjects completed a satisfaction questionnaire at the conclusion of the trial. RESULTS: Ultrasound images showed statistically significant (p < .001) average fat reduction of 2.6 ± 1.1 mm. Reviewers correctly ordered photographs 90.3% of the time. Ninety-six percentage of subjects rated that they were satisfied. Noted side effects were transient mild to moderate tenderness which subsided within 1 to 3 weeks; no serious adverse events were reported. CONCLUSION: The hyperthermic 1,060-nm diode laser treatment used in this study was safe and effective for noninvasive fat reduction of the flank.

Combined Hyperthermic 1060nm Diode Laser Lipolysis With Topical Skin Tightening Treatment: Case Series.

BACKGROUND: As body contouring procedures have become more popular, post-procedural skin laxity is a concern. Non-invasive body contouring technologies may effectively reduce body fat, but modestly affect skin tightening. OBJECTIVE: To assess the efficacy and safety of a topical skin tightening agent in combination with hyperthermic diode laser lipolysis. METHODS: Herein, we describe five patients in which a skin tightening concentrate of 5% yeast extract, 2% hydrolyzed rice protein content, and 2.5% tripeptide was used after 1500-2100 J/cm2 of hyperthermic 1060 nm diode laser. RESULTS: Overall, all patients had a subjective positive response and high satisfaction with the combined treatment results of improvement in skin laxity and fat reduction. In all five cases, patients demonstrated visible fat reduction and skin improvement on photographs taken between weeks 6-18 compared to baseline. Blinded investigators correctly predicted the order of the photographs based on treatment results. No adverse events were reported. CONCLUSION: This case series demonstrated that a combined topical skin tightening concentrate with a hyperthermic laser lipolysis device may achieve improved aesthetic outcomes without adverse events. J Drugs Dermatol. 2018;17(7):780-785.

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.

Efficacy of monopolar dielectric transmission radio frequency in panniculus adiposus and cellulite reduction.

INTRODUCTION: Despite high incidence rate of cellulite, there are few studies regarding its treatment. Most of them present non-validated evaluation tools. Radio frequency is a focused treatment very used in aesthetics to reduce it. OBJECTIVES: To know the efficacy of Monopolar Dielectric Radio frequency (MDR) treatment in dynamic applications to reduce cellulite, panniculus adiposus and gluteal and posterior thigh regions. METHODS: Experimental study consisting of inferior members of nine women. They received 10 sessions based on dynamic applications of MDR. Variables included the following: Cellulite Severity Scale (CSS), appearance of the cutaneous area, flaccidity and ultrasound measurement of the panniculus adiposus. RESULTS: The final CSS score of the leg treated reflects statistically significative differences (p = 0.023) when compared with control leg (p = 0.622). Significant reductions of body perimeters at the level of the great trochanter (p = 0.02), the gluteal region (p = 0.03) and the midpoint of the posterior thigh (p = 0.01) are found. The reduction of the panniculus adiposus measured using ultrasound techniques shows significant changes in the midpoint of the posterior thigh (p = 0.028) as well as in the gluteal region (p = 0.03). CONCLUSIONS: The dynamic application of MDR seems to be effective in order to reduce not only the thickness of panniculus adiposus but also gluteal and posterior thigh perimeters.

Acoustic wave therapy for cellulite, body shaping and fat reduction.

BACKGROUND: Cellulite is a common aesthetic condition that affects almost every woman. OBJECTIVE: To evaluate the efficacy of acoustic wave therapy (AWT) for cellulite and body shaping. METHODS: In this open-label, single-centre trial, 30 women presenting moderate or severe cellulite underwent 12 sessions of AWT on the gluteus and back of the thighs, over six weeks. The following assessments were performed at baseline, and up to 12 weeks after treatment: Cellulite Severity Scale (CSS), body circumference measurements, subcutaneous fat thickness by magnetic resonance imaging (MRI), quality of life related by Celluqol® and a satisfaction questionnaire. RESULTS: The treatment reduced cellulite severity from baseline up to 12 weeks after the last treatment session (subjects presenting severe cellulite: 60% to 38%). The mean CSS shifted from 11.1 to 9.5 (p < 0.001). Hips circumferences reduced from 99.7 and 103.2 cm to 96.2 and 100.3 cm (respectively, p < 0.001). The average thickness of the subcutaneous fat tissue also decreased (28.3 ± 6.5 mm to 26.7 ± 6.1mm; p < 0.001). The treatment also improved quality of life. More than 90% of the subjects would undergo the treatment again and 89% were satisfied with the results. No serious adverse events were reported. CONCLUSIONS: AWT is a safe treatment to improve cellulite appearance and reduce body circumferences.

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..

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.

Quantification of adipose volume reduction with a prospective study analyzing the application of external radiofrequency energy and high voltage ultrashort pulse duration electrical fields.

To date, there have been no objective measurements of subcutaneous volume loss following treatments with a noninvasive radiofrequency (RF)-based device. Twenty female patients were treated with a suction-coupled bipolar RF device using external RF energy combined with pulsed electromagnetic RF energy for subcutaneous fat reduction. Parameters followed included weight, Vectra measurements of abdominal circumference and torso volume, and high-definition ultrasound measurements of fat thickness. Measurements were taken before treatment and three times following treatment. Analysis of the measured parameters showed that mean circumference reduction of 2.30 cm was noted at three months post-treatment. Independent volumetric analysis showed a mean subcutaneous volume reduction of 428 cc three months following RF treatment. High-resolution ultrasound fat thickness was reduced by a mean of 39.6% three months following the final BodyFX treatment. Independent and paired-sample t-tests showed a p value of < 0.05. Repeated measures of analysis of covariance (ANCOVA) adjusted for differences in age, as well as height and weight (proxy for body mass index) to minimize individual differences and control for extraneous variables that may affect the pre- and post-treatment results were analyzed. No confounding variables were found. All analyses were conducted using IBM SPSS 21.0.

"Hands-Free" Noninvasive Body Contouring Devices: Review of Effectiveness and Patient Satisfaction.

The demand for body contouring is increasing rapidly and has generated the need for a variety of non-invasive body contouring devices. This review concentrates on three popular "hands-free" body contouring devices and analyzes their mechanism of action, as well as their evidence of safety and ef cacy. It also addresses some issues of usability from both the operators' and patients' point of view. J Drugs Dermatol. 2016;15(11):1402-1406..

Prospective Internally Controlled Blind Reviewed Clinical Evaluation of Cryolipolysis Combined With Multipolar Radiofrequency andVaripulseTechnology for Enhanced Subject Results in Circumferential Fat Reduction and Skin Laxity of the Flanks.

BACKGROUND: Increasing demand for non-invasive skin tightening and body contouring procedures has led to several technological in- novations in energy-based devices such as ultrasound, radiofrequency and cryolipolysis. An emerging trend in the eld is to evaluate whether combination therapies for skin laxity/body contouring using energy-based devices can deliver superior clinical results and patient satisfaction. As such, the objective of this prospective, internal-controlled, blind clinical study was to assess the safety and efficacy of cryolipolysis followed by multipolar radiofrequency with pulsed electromagnetic elds (PEMF) and adjustable pulsed suction for the treatment of skin laxity in the flanks. METHODS: Ten subjects with focal adiposities in the anks were enrolled in the study. All subjects received one session of cryolipolysis treatment and after randomization received two sessions of radiofrequency with PEMF (spaced two weeks apart), followed by another two sessions of radiofrequency with PEMF and adjustable pulsed suction (spaced two weeks apart). Clinical photography was used to monitor the subject's results at baseline, one week, three, and six months post treatment. Blinded reviewers and the treating inves- tigator assessed the clinical outcomes using the Global Aesthetic Improvement (GAI) scale. Side effects were recorded at every visit and patient satisfaction was noted at the one week, three and six-month follow-up using a 5-scale subject satisfaction assessment questionnaire. RESULTS: Analysis of the blinded investigator ratings demonstrated statistical significant enhanced skin laxity mean improvement of 1 grade on the GAI scale in subject treated with the combination treatment (cryolipolysis+RF/PEMF/suction) compared with the cryolipolysis treatment alone. The unblinded investigator GAI ratings also showed enhanced (20%) mean improvement of laxity in the combination treated subjects versus those receiving cryolipolysis alone. Over half of the participants reported satisfaction with both treatment results, but there was a 10% statistically significant higher satisfaction rating of the outcomes in the flank treated with the combination treatment. Procedures were well tolerated, side effects were transient and self-resolving and no unexpected adverse effects were reported for the duration of the study. CONCLUSION: The results of this study show that the combination of multipolar RF with PEMF/suction following cryolipolysis is a safe, effective, and painless approach to enhance skin tightening following fat reduction procedures in the flanks. J Drugs Dermatol. 2016;15(11):1354-1358..

Evaluation of the Safety and Efficacy of a Non-contact Radiofrequency Device for the Improvement in Contour and Circumferential Reduction of the Inner and Outer Thigh.

BACKGROUND AND OBJECTIVE: When evaluating self-image, research confirms that the main focus of dissatisfaction for the majority of women is the size and shape of their bodies, particularly their hips, waist and thighs. The appearance of a woman's thighs is often distanced from what she views as her ideal shape and size and is largely out of her control due to gender specific fat deposition. The issue of excessive subcutaneous fat deposits in the lateral thigh area is enhanced by the resistivity of local adipocytes to lipolysis. Subjects in this study underwent treatment of the bilateral inner and outer thighs using a non-contact field radiofrequency device (BTL Vanquish Flex Applicator, BTL Industries Inc., Boston, MA). The main objective of this study is to evaluate the safety and efficacy of the device for reducing the circumference of the inner and outer thighs as well as improving the overall contour of the treatment area. MATERIALS AND METHODS: A total of 30 female subjects age 32 to 59 (average 42.4) were enrolled in the study. After meeting the inclusion/ exclusion criteria each subject received 4 weekly 30-minute bilateral thigh treatments (1 hour total treatment time). As the primary outcomes, circumferential reduction was measured and clinical before and after photographs were taken for assessment. Safety of the device was assessed by means of reported adverse events. RESULTS: All 30 subjects completed the entire treatment series and 1 month follow-up visit. The average reduction measured on both thighs was 3.86 cm with statistical significance P< 0.05. There was no significant change in weight for any of the subjects. During the course of the study two adverse events occurred, but were deemed unrelated to the treatment. CONCLUSIONS: Based on the measurements obtained the device under investigation was considered safe and effective in terms of improved contour and circumferential reduction of inner and outer thighs.

Human Adipocyte Apoptosis Immediately Following High Frequency Focused Field Radio Frequency: Case Study.

BACKGROUND: A previously published study used a radio frequency (RF) focused field device (Vanquish, BTL Industries Ltd., Framingham, MA) to reduce porcine abdominal fat. The purpose of this case study was to reproduce the veterinary study on human subjects. The primary objective was measurement of apoptotic index before and after treatment with the RF device. As a second outcome demonstrating selective heating and safety, superficial skin temperature and temperature 1 and 2 cm into the subcutaneous tissue were measured. METHODS AND MEASUREMENTS: Two healthy female subjects underwent abdominal skin and fat biopsies at baseline and after one treatment with a similar focused field high frequency RF device capable of 200 watts for 45 minutes. Biopsies were performed 1 hour post-treatment and were analyzed using the TUNEL method. Infrared imaging of the skin surface temperature was measured in both subjects. Thermocouple measurements at 1 and 2 cm were performed during the treatment cycle on a single subject. RESULTS: Histologic apoptotic index (pre and 1 hour post) showed an average increase of 487% (6.5 to 31.7). Thermal imaging demonstrated an average surface temperature of 31.6C° pre-treatment and 39.2°C post-treatment. The 1 cm depth thermocouple showed an initial temperature of 40C° and reached a maximum of 45°C 15 minutes into the treatment. It remained stable at 45°C for the remaining 30 minutes treatment time. No adverse events were noted. CONCLUSION: RF treatment induces an increase in apoptotic index in adipocytes 1 hour post-RF treatment. This is accompanied by a peak temperature of 45°C in the fat layer. Skin surface temperatures remain substantially lower than fat temperatures.

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.

Cell and Tissue Damage after Skin Exposure to Ionizing Radiation: Short- and Long-Term Effects after a Single and Fractional Doses.

Ionizing radiation is often used to treat progressive neoplasms. However, the consequences of long-term radiation exposure to healthy skin tissue are poorly understood. We aimed to evaluate the short- and long-term radiation damage to healthy skin of the same irradiation given either as single or fractional doses. C57BL/J6 mice were randomly assigned to one of three groups: a control and two exposure groups (5 Gy ×2 or 10 Gy ×1). The inguinal area was irradiated (6-MeV beam) 1 week after depilation in the treatment groups. Skin samples were evaluated macroscopically and histologically for up to 6 months after the final exposure. After anagen hair follicle injury by irradiation, hair cycling resumed in both groups, but hair graying was observed in the 10 Gy ×1 group but not in the 5 Gy ×2 group, suggesting the dose of each fractional exposure is more relevant to melanocyte stem cell damage than the total dose. On the other hand, in the long term, the fractional double exposures induced more severe atrophy and capillary reduction in the dermis and subcutis, suggesting fractional exposure may cause more depletion of tissue stem cells and endothelial cells in the tissue. Thus, our results indicated that there were differences between the degrees of damage that occurred as a result of a single exposure compared with fractional exposures to ionizing radiation: the former induces more severe acute injury to the skin with irreversible depigmentation of hairs, while the latter induces long-term damage to the dermis and subcutis.

Efficacy and safety of continuous low-irradiance photodynamic therapy in the treatment of chest wall progression of breast cancer.

BACKGROUND: Photodynamic therapy (PDT) is a binary therapy using a drug and high-energy light source. PDT is approved for several premalignant and malignant conditions. Recent in-vitro and animal data suggest that enhanced tumor-specific cytotoxicity can be achieved with far less collateral damage to normal surrounding tissues if PDT is administered continuously at a lower dose rate for extended periods of time. Based on these promising preclinical data, we conducted a Phase I clinical trial of continuous low-irradiance photodynamic therapy (CLIPT) using 630 nm laser energy and intravenously administered porforin sodium as the photosensitizer. We determined the maximum tolerated dose (MTD) of CLIPT on skin and tumor response in subjects with cutaneous and subcutaneous metastatic nodules who had failed radiation and surgery. METHODS: Patients with cutaneous and/or subcutaneous metastatic nodules that had failed radiation and surgery were offered enrollment into the trial. The initial study design planned for sequential cohorts of six subjects to be treated at increasing laser intensity, starting at 100 J/cm(2) administered continuously over 24 h (10(-2) dose rate compared with standard PDT). Dose-limiting toxicity was defined as partial or full-thickness necrosis of the surrounding tumor-free, previously irradiated skin. The MTD was defined as the highest laser energy at which ≤33% of subjects experienced the dose-limiting toxicity. Subjects received intravenous porfirmer sodium 0.8 mg/kg 48 h before commencing CLIPT. Response rates and quality of life measures were assessed. RESULTS: Nine subjects were enrolled with chest wall progression of breast cancer following mastectomy. All had failed prior surgery and electron-beam radiation therapy. The initial two subjects were treated at 100 J/cm(2) and developed partial thickness skin necrosis. Dose reduction was therefore instituted, and the next cohort was treated at 50 J/cm(2). None of the subsequent seven subjects suffered partial or full thickness necrosis, thus establishing the MTD at 50 J/cm(2) over 24 h (0.5 mW irradiance). Six of the nine subjects (67%) had either a complete or partial clinical response. Of note, two subjects had significant regression of tumor nodules distant from the treatment field. Of the eight subjects whose terminal deoxynucleotidyl transferase dUTP nick end labeling assay results were available, 8 (100%) demonstrated histologic response to treatment as evidenced by either tumor apoptosis or regression. Quality of life measures were improved following treatment-particularly bleeding and pain from the tumor nodules. CONCLUSIONS: The MTD of CLIPT was established at 50 J/cm(2) administered continuously over 24 h. These preliminary data suggest CLIPT may be an effective, low-morbidity therapeutic modality in the treatment of cutaneous and subcutaneous metastases of breast cancer following mastectomy. Further evaluation in a larger cohort is warranted to better assess efficacy and optimize the intervention.

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.

A focused monopolar radiofrequency causes apoptosis: a porcine model.

BACKGROUND: The purpose of this study was to demonstrate the effect of monopolar, focused radiofrequency (RF) with embedded cooling on subcutaneous skin structures. Specifically, the study was to prove that the monopolar RF with cooling can selectively heat fat, causing disintegration of adipocytes and programmed cell death (apoptosis) of the subcutaneous fat cells. METHODS: A non-invasive monopolar RF device with cooling (Exilis Elite, BTL Industries, Framingham, MA) was used to reduce abdominal fat in a porcine model. The study was done on 3 Vietnamese pigs in a certified veterinary facility. The treatment was delivered to an area the size of 20 x 10cm. The treatment duration was 11 minutes, 30 seconds. Biopsy samples were taken before the first treatment, 1 hour post each treatment, as well as 8 and 20 hours post each treatment. Programmed cell death (apoptosis) was monitored using the TUNEL method. The temperature was measured on the skin surface by an infrared thermal imager and built-in IR thermometer, and by an internal probe inserted into various depths of the subcutaneous layer. The internal probe placement was monitored by diagnostic ultrasound examination. RESULTS: The temperature in the treated adipose tissue was higher compared to the skin surface temperature. The average temperature gradient observed was 3.1°C. Due to the temperature gradient the skin surface remained intact, while subcutaneous layers showed significant changes. The TUNEL method proved large-scale apoptosis of fat cells after each treatment. The apoptotic index increased from 7% before the first treatment to an average of 53.4%, 39.6%, 40.2%, and 44.7% respectively for each treatment. In the three-month follow up the apoptotic index dropped back to 11.7%. Histology, blood biochemistry and hematology samples showed mild to no signs of inflammation in the treated area. CONCLUSION: The study has shown that use of monopolar, focused radiofrequency can induce substantial apoptotic process in a porcine model. The data suggests that the monopolar, focused radiofrequency device can be used for reduction of fat and body shaping.

Effect of fibrous septa in radiofrequency heating of cutaneous and subcutaneous tissues: computational study.

BACKGROUND AND OBJECTIVES: Radiofrequency (RF) energy exposure is a popular non-invasive method for generating heat within cutaneous and subcutaneous tissues. Subcutaneous fat consists of fine collagen fibrous septa meshed with clusters of adipocytes having distinct structural, electrical and thermal properties that affect the distribution and deposition of RF energy. The objectives of this work are to (i) determine the electric and thermal effects of the fibrous septa in the RF heating; (ii) investigate the RF heating of individual fat lobules enclosed by fibrous septa; and, (iii) discuss the clinical implications. METHODS AND RESULTS: We used the finite element method to model the two-dimensional, time-dependent, electro-thermal response of a three-layer tissue (skin, subcutaneous fat, and muscle). We considered two different configurations of subcutaneous fat tissue: a homogenous layer of fat only and a honeycomb-like layer of fat with septa. Architecture of the fibrous septa was anatomically accurate, constructed from sagittal images from human micro-MRI. For a large electrode applied to the skin surface, results show that the absorbed electric power density is greater in some septa than in the surrounding fat lobules, favoring the flux of electric current density. Fibers aligned parallel to the electric field have higher electric flux and, consequently, absorb more power. Heat transfer from the septa occurs over time during and after RF energy delivery. There is a greater temperature rise in fat with fibrous septa. CONCLUSIONS: The presence of septa affects the local distribution of the static electric field, facilitates the flux of electric current and enhances the bulk electric power absorption of the subcutaneous fat layer. Fibrous septa aligned with the local electric field have higher absorbed power density than septa oriented perpendicular to the electric field. Individual fat lobules gain heat instantly by local power absorption and, eventually, by diffusion from the surrounding septa.