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.     

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.     

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.     

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.     

Painless,safe, and efficacious noninvasive skin tightening,body contouring,and cellulite reduction using multisource 3DEEP radiofrequency

In the last decade, Radiofrequency (RF) energy has proven to be safe and highly efficacious for face and neck skin tightening, body contouring, and cellulite reduction. In contrast to first‐generation Monopolar/Bipolar and “X ‐Polar” RF systems which use one RF generator connected to one or more skin electrodes, multisource radiofrequency devices use six independent RF generators allowing efficient dermal heating to 52–55 °C, with no pain or risk of other side effects. In this review, the basic science and clinical results of body contouring and cellulite treatment using multisource radiofrequency system (Endymed PRO, Endymed, Cesarea, Israel) will be discussed and analyzed.     

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.     

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.     

Comparison of the effects of carboxytherapy and radiofrequency on skin rejuvenation

Background: Carboxytherapy (CA) refers to the cutaneous and subcutaneous administration of CO₂ for therapeutic purposes. Radiofrequency (RF) is a method that uses electric current for heating layers of the skin. Both techniques are indicated for the treatment of skin laxity. Objective: The aim of this study was to compare the effects of CA and RF on human skin. Methods: After eight patients underwent abdominoplasty, each of them received a single treatment of CA and a single treatment of RF on the right and left infra-umbilical regions, respectively. In the infra-umbilical region, CA was performed on the right and RF was performed on the left side. Untreated skin was used as a control. The sample collection period lasted 120 days. CA was administered at a velocity of 40 mL/min, and the total quantity of CO₂ infused was approximately 20 mL. RF was carried out at a temperature higher than 40°C on the epidermis for 5 min. Results: CA and RF led to collagen remodeling; however, this result was more evident and lasted longer with RF. With CA an increase in elastic fibers was observed, whereas with RF no alteration was observed. Conclusion: Our results suggest that RF is more efficient than CA in stimulating collagen synthesis.     

Combined treatment for skin laxity of the aging face with monopolar radiofrequency and intense focused ultrasound in Korean subjects

Background: Although various minimal invasive approaches are available for aging skin laxity, they alone may not lead to notably satisfactory results. Objective: To evaluate the effectiveness and safety of combination regimen with monopolar radiofrequency (MRF) and intense-focused ultrasound (IFUS) in facial lifting and tightening. Methods: Twenty-two Korean participants with aging face received a sequential single session of MRF and IFUS treatment. Objective and subjective assessments for improvement were performed at the 20-week post-treatment. Safety profiles were also recorded, and skin biopsies were taken at baseline and follow-up visit. Results: Based on the objective assessment for the overall facial skin tightening and laxity, 19 patients (90%) demonstrated “moderate” or better improvements (more than 25%) compared with baseline. Specifically, improvements of skin laxity and sagging, and droopy jaw line were more noticeable compared with that of superficial skin texture (P < 0.05). Subjective satisfactions were generally consistent with objective findings, and no serious adverse effect was observed. Histologic evaluation showed increased dermal collagen fibers throughout the dermis after treatments (P < 0.05). Conclusion: Combination treatment of MRF and IFUS has cumulative benefits for skin lifting and tightening with satisfactory safety profiles in Asian subjects.     

Efficacy of monopolar radiofrequency on skin collagen remodeling: a veterinary study

The aesthetic market offers various radiofrequency treatments for the reduction of wrinkles and rhytids. Even though this not an uncommon aesthetic therapy, there is considerable lack of clinical evidence on the various energy delivery systems available (unipolar, bipolar, tripolar, multipolar, etc.). The purpose of this study was to demonstrate the efficacy of a monopolar radiofrequency device (Exilis Elite, BTL Industries Inc., Boston, MA, USA) on the skin collagen in an animal model. The study treatment was done on the abdominal area of the potbellied Vietnamese mini pigs in the Veterinary Research Institute facility. All pigs were treated once per week for 4 weeks. The treatment area was sized 20 × 10cm. The surface temperature was kept in the therapeutic interval from 39°C to 43°C and the therapy lasted for 10 minutes after reaching the therapeutic temperature. Biopsy samples were taken before the therapy and at the 3‐month follow‐up. The histology samples were stained and magnified (×400) before computer processing. The collagen volume was calculated using the stereological analysis and the data were statistically processed (using the nonparametric two‐sample t‐test). The collagen content tissue increased from average of 9.0% before the therapy up to 25.9% after the 3‐month follow‐up period. The statistical comparison of 54 samples taken before and after the treatment acknowledged the significant difference (p = 0.018). The stereological analysis proved large‐scale improvement of collagen in the treated area. We have observed that the monopolar radiofrequency therapy significantly increases collagen remodeling.