Use of a novel combined radiofrequency and ultrasound device for lipolysis,skin tightening and cellulite treatment

Introduction: Skin laxity and excessive subcutaneous fat are growing cosmetic concerns. The objective of this study is to evaluate the efficacy and safety of a novel radiofrequency and ultrasound workstation for lipolysis, circumference reduction, treatment of skin laxity and cellulite. Materials and methods: Two hundred seventy-five (235 women and 40 men) patients were enrolled into the study. Each patient received 3 treatment sessions, each session comprising Ultrasound and Radiofrequency treatments, at two-week intervals. Some received treatment for the abdomen, some for the thighs and some for both. Efficacy was assessed accordingly by measuring changes in abdominal circumference, thigh circumference and appearance of cellulite. Any adverse effect was noted. Result: Paired t-test between measurements at baseline and 4 weeks after 3rd session was significant amongst all the groups, showing that most patients showed improvement in abdominal and/or thigh circumferences. No significant adverse effects were noted during or after the treatment. Conclusion: A combination of alternating hot and cold module Ultrasound and Radiofrequency technologies is a safe and effective modality for lipolysis and to treat skin laxity and cellulite.     

Review of non-invasive body contouring devices for fat reduction,skin tightening and muscle definition

Non-invasive body contouring is a rapidly growing field in cosmetic dermatology. Non-invasive contouring devices improve the body's appearance through the removal of excess adipose tissue, particularly in areas in which fat persists despite optimal diet and exercise routine. The technology can also be used for skin tightening. This article reviews the five FDA-approved non-invasive body contouring modalities: cryolipolysis, laser, high-intensity focused electromagnetic field, radiofrequency and high-intensity focused ultrasound. These devices have emerged as a popular alternative to surgical body contouring due to their efficacy, favourable safety profile, minimal recovery time and reduced cost. Although they do not achieve the same results as liposuction, they are an attractive alternative for patients who do not want the risks or costs associated with surgery. When used appropriately and correctly, these devices have demonstrated excellent clinical efficacy and safety.     

A novel method for real-time skin impedance measurement during radiofrequency skin tightening treatments

The thermal effects of monopolar and bipolar radiofrequency (RF) have been proven to be beneficial in skin tightening. Nevertheless, these effects were frequently partial or unpredictable because of the uncontrolled nature of monopolar or unipolar RF and the superficial nature of energy flow for bipolar or tripolar configurations. One of the hypotheses for lack or predictability of efficacy of the first‐generation RF therapy skin tightening systems is lack of adaptation of delivered power to differences in individual skin impedance. A novel multisource phase–controlled system was used (1 MHz, power range 0–65 W) for treatment and real‐time skin impedance measurements in 24 patients (EndyMed PRO?; EndyMed, Cesarea, Israel). This system allows continuous real‐time measurement of skin impedance delivering constant energy to the patient skin independent of changes in its impedance. More than 6000 unique skin impedance measurements on 22 patients showed an average session impedance range was 215–584 Ohm with an average of 369 Ohm (standard deviation of 49 Ohm). Analyzing individual pulses (total of 600 readings) showed a significant decrease in impedance during the pulse. These findings validate the expected differences in skin impedance between individual patients and in the same patients during the treatment pulse. Clinical study on 30 patients with facial skin aging using the device has shown high predictability of efficacy (86.7% of patients had good results or better at 3 months’ follow‐up [decrease of 2 or more grades in Fitzpatrick’s wrinkle scale]). The real‐time customization of energy according to skin impedance allows a significantly more accurate and safe method of nonablative skin tightening with more consistent and predictable results.     

Treatment of abdominal cellulite and circumference reduction with radiofrequency and dynamic muscle activation

Background: Cellulite is a frequent skin condition for which treatment remains a challenge. A wide variety of treatments are available but most procedures offer suboptimal clinical effect and/or delayed therapeutic outcome. Only few therapeutic options have proven efficacy in the treatment of cellulite. Objective: To determine the efficacy and the safety profiles of radiofrequency and dynamic muscle activation technology in treatment of abdominal cellulite and circumference reduction. Methods: Twenty-five females with abdominal cellulite received 6 weekly radiofrequency and dynamic muscle activation treatments. Treatment areas included the abdomen and both sides of flanks. Subjects were evaluated using standardized photographs, and measurements of body weight and abdominal circumference at baseline, before every treatment visit, and 1 week and four weeks after the final treatment. Subcutaneous tissue thickness was recorded by ultrasound at baseline and 4 weeks after completion of treatment protocol. Physicians’ evaluation and patient's satisfaction of clinical improvement were also measured. Results: All subjects completed the treatment protocol and attended every follow-up visits. There was significant abdominal circumference reduction of 2.96 and 2.52 cm at 1-, and 4-week follow-up visits (p < 0.05), respectively. At four weeks after the last treatment, the average circumferential reduction was sustained. Most of the patients were rated to have 25–49% improvement at 5th treatment, and 1- and 4-week follow-up visits. Ninety-two percent of the patients were satisfied with the treatment outcome. Conclusions: Radiofrequency provided beneficial effects on the reduction of abdomen and cellulite appearance. The benefit of muscle activation is yet to be determined.     

A novel non-invasive radiofrequency dermal heating device for skin tightening of the face and neck

Background: Loose, lax skin is a common cosmetic complaint. Previous non-invasive skin tightening devices had modest efficacy and were associated with pain or downtime. New technologies may allow for effective skin tightening with a series of radiofrequency (RF) treatments with no downtime. Objective: To evaluate the efficacy and safety of a novel bipolar RF device for skin tightening. Methods: Fifteen consecutive female patients were enrolled in the case series; 14 completed the study and were included in the analysis. The device under investigation is a novel, bipolar RF device allowing for achievement and maintenance of optimal dermal temperatures to stimulate collagen remodeling and skin tightening. Patients underwent a series of 4–6 weekly treatments. Three blinded, experienced cosmetic physicians evaluated paired pre-treatment and post-treatment photographs and determined the associated improvement, if any. Results: All patients (14/14) were determined to have a clinical improvement, as the pre-treatment and post-treatment photographs were correctly identified by the evaluators. It was observed that 21% (3/14) of patients had significant improvement, 50% (7/14) had moderate improvement, and 29% (4/14) had mild improvement. No pain, side effects, or adverse events were observed. Conclusions: This novel bipolar RF device represents a safe, effective treatment option for non-invasive skin tightening.     

Safety and efficacy of a non-contact radiofrequency device for body contouring in Asians

Background: The non-invasive reduction of subcutaneous abdominal fat became popular. Radiofrequency, non-contact, selective-field device Vanquish® has been developed to selectively induce deep fat tissue heating to reduce waist circumference. Objective: The objective of this study was to evaluate the efficacy and safety of clinical, radiological results of the radiofrequency, non-contact, selective-field device treatment. Methods: Twelve healthy individuals with no underlying medical problem were treated with five sessions of radiofrequency treatment to reduce abdominal subcutaneous fat. 45-minute sessions were performed with an 1-week interval. For efficacy evaluation, patient’s abdominal circumferences and body weight were measured, and photographs were taken at baseline and each follow-up visit for 12 weeks. One subject was examined with computed tomography (CT) before the first session and six weeks after the first CT scan, and we measured the volume of subcutaneous fat layer. Any adverse effect was assessed during the entire study period. Results: Reduction in abdominal circumferences was noted in most participants (10 of 12 patients). No serious adverse effect was reported. Volume reduction of abdominal subcutaneous fat layer was confirmed in a subject who took CT scan. Conclusions: Our study shows that the selective-field radiofrequency treatment seems to be safe and efficient for reduction of abdominal subcutaneous fat.     

A prospective study analyzing the application of radiofrequency energy and high-voltage,ultrashort pulse duration electrical fields on the quantitative reduction of adipose tissue

Noninvasive fat reduction is claimed by many device manufacturers, but proof of efficacy has been difficult to establish. This prospective study was designed to measure the reduction of fat thickness and actual volume reduction in 20 female patients treated with an external radiofrequency (RF) device. This device combines RF heat, suction coupled vacuum, and oscillating electrical pulses that induce adipocyte death over time. Patients underwent pre- and post-treatment and intercurrent measurements of weight, body mass index, ultrasonic transcutaneous fat thickness, and 2D and 3D Vectra photography with independent calculation of circumferential and volumetric change. Mean transcutaneous ultrasound thickness at reproducible points was 2.78 cm; at 1-month post-treatment, the mean fat thickness was 1.71 cm. At 3-month post-treatment, the mean fat thickness reduction was 39.6%. Vectra circumference measurements were taken at 10-mm intervals, with postural and breathing cycle control. Independent analysis of serial measurements from + 60 to ? 70 mm showed mean abdominal circumference measurement of 2.3 cm. Mean abdominal volume loss was 202.4 and 428.5 cc at 1- and 3-month post-treatment, respectively. Scanning electron microscopy confirmed that permanent cell destruction was caused by irreversible electroporation. Pyroptosis appears to be the mechanism of action.     

Split-face histological and biochemical evaluation of tightening efficacy using temperature- and impedance-controlled continuous non-invasive radiofrequency energy

Background: Bipolar radiofrequency (RF) is capable of heating dermal collagen fibers and inducing skin tightening by collagen remodeling. Objective: To substantiate safety and improvement of skin laxity following skin heating with a novel temperature- and impedance-controlled non-invasive radiofrequency (RF) device by histological and biochemical evaluations. Methods: A split-face study was performed on 4 subjects who underwent 8 weekly RF sessions on one side of their face, leaving the other side an untreated control and then underwent facelift procedure. Clinical evaluation by photographs was done prior to the surgical procedure. Ex vivo fragments were harvested from both sides and compared. Morphometric analysis of dermal collagen fibers, collagen synthesis, and elastin synthesis evaluations were compared in triplicates. Results: Facial skin tightening was apparent in split-face photographs. A significant increase of 7.9% in dermal collagen content, and a significant increase of 34.7% in collagen synthesis were demonstrated in the treated samples. No statistically significant effect on elastin synthesis was detected. Conclusions: Skin tightening following treatment with non-invasive RF has proven histologically and biochemically to derive from increase in dermal collagen synthesis and content.     

Combination of microneedle radiofrequency (RF), fractional RF skin resurfacing and multi-source non-ablative skin tightening for minimal-downtime,full-face skin rejuvenation

Background: In the recent years, there is a growth in demand for radiofrequency (RF)-based procedures to improve skin texture, laxity and contour. The new generation of systems allow non-invasive and fractional resurfacing treatments on one platform. Objective: The aim of this study was to evaluate the safety and efficacy of a new treatment protocol using a multisource RF, combining 3 different modalities in each patient: [1] non-ablative RF skin tightening, [2] fractional skin resurfacing, and [3] microneedling RF for non-ablative coagulation and collagen remodelling. Methods: 14 subjects were enrolled in this study using EndyMed PRO^? platform. Each patient had 8 non-ablative treatments and 4 fractional treatments (fractional skin resurfacing and Intensif). Results: The global aesthetic score was used to evaluate improvement. All patients had improvement in skin appearance. About 43% had excellent or very good improvement above 50%, 18% had good improvement between 25 and 50%, and the rest 39% had a mild improvement of < 25%. Downtime was minimal and no adverse effect was reported. Conclusions: Our data show significant improvement of skin texture, skin laxity and wrinkle reduction achieved using RF treatment platform.     

A 12-week clinical and instrumental study evaluating the efficacy of a multisource radiofrequency home-use device for wrinkle reduction and improvement in skin tone,skin elasticity,and dermal collagen content

This study was performed in order to evaluate the safety and efficacy of a new handheld home-use multisource radiofrequency device on facial rejuvenation. Forty-seven male and female subjects were enrolled. All subjects received a NEWA^® 3DEEP^? home-use device (EndyMed Medical, Caesarea, Israel) to be used on facial skin three times per week for the first four weeks and then reduced to two times per week for the following eight weeks. Assessments included expert clinical grading for efficacy, instrumental evaluation, image analysis, and photography. Forty-five subjects completed the study; all subjects reported the treatment to be painless with only mild erythema lasting up to 15 minutes post-treatment. No other adverse events were reported. Statistically significant improvements were noted in the appearance of marionette lines, skin brightness, elasticity, firmness, lift (facial), lift (jawline), texture/smoothness, tone, and radiance/luminosity by expert visual assessment. Statistically significant improvements in skin firmness and elasticity were found using a Cutometer MPA 580, as well as in collagen and hemoglobin content of the skin using a SIAscope. The results of this study indicate that the NEWA^® multisource radiofrequency home-use device is effective in self-administered skin rejuvenation.     

New vision in fractional radiofrequency technology with switching,vacuum and cooling

Introduction: Since the introduction of fractional technology, various systems were launched to the market. The first generation of fractional RF systems created epidermal ablation with coagulative/necrosis of the dermis with sufficient clinical outcomes, but with some limitations. The aim of this study was to evaluate the efficacy and safety of SVC technology, based on the principle of separate biological responses. Material and methods: Fifty-two patients were treated for 3–6 sessions using fractional RF handpiece and eight patients received combination treatments with non-invasive RF handpiece. Results: All volunteers showed notable to significant improvement in the photoageing symptoms, without any significant complications or adverse events. Discussion: Due to its wide spectrum of parameters, the SVC technology can promote different biological responses. Owing to the “Switching” technology, the control of energy depth penetration enables delivery of the necessary thermal dose to the targeted skin layer. In addition, this novel technology includes the “Vacuum” and “Cooling” mechanisms, each contributing to the safety of the treatment. The Smart Heat function reduces the necessary energy levels and thereby reduces the pain level and risks for side effects.     

Adipose tissue,fillers, and skin tightening

The role of adipose tissue has long been underestimated in esthetic dermatology. With the development of liposculpture and lipolysis, subcutaneous adipose tissue has gained an increasing interest. Harvested tissue has been used for lipofilling. In recent years, a better understanding of adipocyte physiology and its role in aging opened a new road for targeted treatments. Subcutaneous adipose tissue is no longer an innocent bystander in the combat of aging and the correction in esthetics. Adipose tissue is of importance for metabolic function and thermoregulation. Adipose tissue is involved in inflammation. Adipose tissue is heterogeneous in sense of function, color and size of adipocytes. The tissue is an important source of somatic stem cells.     

Broadband light treatment using static operation and constant motion techniques for skin tightening in Asian patients

Background: Broadband light (BBL) devices irradiate photons of different wavelength to induce photothermal reactions on various aging-related chromophores.

Objectives: To evaluate three BBL treatment settings for skin tightening in Asian patients.

Methods: A total of 27 patients underwent three sessions of BBL treatment via (1) an 800-nm cutoff filter using a static operation technique and a 695-nm cutoff filter using a constant motion technique (group 1, N = 9), (2) an 800-nm cutoff filter using a constant motion technique (group 2, N = 9), and (3) a 590-nm cutoff filter using a constant motion technique (group 3, N = 9).

Results: The patients in group 1 presented marked clinical improvements in zygomatic wrinkles, nasolabial folds, and marionette lines, with a median overall global aesthetic improvement scale (GAIS) score of 3. Meanwhile, patients in group 2 exhibited noticeable improvements in zygomatic wrinkles, nasolabial folds, perioral expression wrinkles at the cheek, and marionette lines, with a median GAIS score of 3. Patients in group 3 experienced improvement in skin tone and texture, zygomatic wrinkles, nasolabial folds, and marionette lines, with a median GAIS score of 2.

Conclusions: Our data demonstrated that BBL treatment for nonablative, noninvasive skin tightening elicits satisfactory clinical outcomes.     

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.     

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.