From Simulation to Reality: A Comprehensive Study on the Efficacy of a Rotating Monopolar and Bipolar Radiofrequency System through In-Silico Modeling and Pre-Clinical and Clinical Validation

Background: Skin aging is an unavoidable process aggravated by environmental agents. Among other energy devices, non-invasive radiofrequency (RF) technology is widely used for skin tightening and body contouring as it is simpler and more affordable than other technologies that also minimize pain and side-effects. However, most of the current RF devices do not provide automatic skin temperature control and it is difficult to achieve controlled, deep, and harmless thermal increase, so treatment performance and safety is dependent on the operator’s movements and expertise. Objective: To show the potential of numerical simulations for optimizing the design of monopolar and bipolar RF electrodes that are capable of providing homogeneous, deep and controlled heating. Materials and methods: In-silico models were developed and analyzed using Comsol Multiphysics software to simulate the RF effect produced in tissue by rotating monopolar and bipolar electrodes with different geometries from the Sculpt & Shape RF device (Sinclair, Spain), operating at frequencies of 0.5 and 1 MHz. Ex-vivo and in-vivo proof-of-concept tests were carried out to validate the simulations. Finally, treatments were performed on 16 subjects and a total of 78 body areas to assess the clinical results generated by the RF electrodes for skin tightening and body contouring. Results: In-silico studies emulated the superficial and deep dispersion of heat due to the release of RF energy into human skin tissue. The rotating electrodes (monopolar and bipolar) and the selected RF frequency (0.5 and 1 MHz) determined the homogeneity of the thermal distribution, the penetration depth (between 4.37 mm and 25.0 mm) and the heating dynamics (between 30 and 100 seconds to reach the target skin temperature), which were confirmed by ex-vivo and in-vivo tests. In addition, real treatments on facial and body areas using skin temperatures of between 43˚C and 44˚C showed consistent results with good clinical efficacy for skin tightening, circumference reduction and cellulite reduction, with no adverse effects and high subject satisfaction. Conclusions: New monopolar and bipolar RF electrodes with rotating technology have been designed and optimized using numerical simulations. The use of in-silico studies and accurate models that reproduce the thermal behavior of human biological tissues can be used to better understand RF devices and to develop superior, efficient, and safer products more quickly.

New Rotative Radiofrequency Technology: A Multicenter Retrospective Study on Efficacy and Safety

Background: Non-ablative radiofrequency (RF) technology is widely used for the treatment of signs of aging, skin laxity, localized fat and cellulite. However, many RF devices suffer from technical limitations that make the results highly dependent on the user’s experience or clinical limitations that compromise safety, efficacy and comfort. Objective: To evaluate the efficacy and safety of a novel semi-automatic non-ablative RF device for skin tightening, body shaping and cellulite reduction. Materials and methods: A retrospective multicenter study was performed using a novel rotative RF device with temperature and impedance control (Sculpt&Shape®, Sinclair, Spain). 58 subjects underwent a minimum of 4 treatments every 1-2 weeks. A total of 120 treatments (56.7% body and 43.3% facial) and 1034 sessions were performed. Efficacy was evaluated by 3 researchers using the Global Aesthetic Improvement Scale (GAIS) and anthropometric measurements were collected. Subject and practitioner satisfaction were recorded. Safety was evaluated by analyzing the perception of pain during the treatment and the side and adverse effects immediately after treatment and over the next 48 hours. Results: Between 25% and 50% improvement was achieved according to the GAIS. Statistically significant (p < 0.01) abdominal fold reduction of 5.1 mm and circumference reduction of 32.0 mm, 16.4 mm and 13.9 mm were recorded for the abdomen, legs and arms, respectively. 77.5% of subjects and 94.9% of practitioners were either satisfied or very satisfied. Minor adverse effects were found in 0.97% of the sessions. Conclusion: This novel semi-automatic rotative RF device has been found to provide treatments that are effective, safe and comfortable for both practitioners and subjects. .

A Rare Cause of Facial Cellulitis

Facial cellulite are infections of the cellulo-adipose tissues of the human face. Head and neck cellulitis is today one of the most serious ENT emergencies, which is very life-threatening and requires immediate multidisciplinary care. Diabetes mellitus is one of the most common predisposing factors. They are serious conditions because of the rapidity with which they tend to spread. They perform an extensive necrotizing condition, developing from a banal, pharyngeal or dental infection, and spreading along the aponeurotic partitions of the face and neck. The etiologies are diverse and come mainly from dental infections. Nasosinus infections can be the cause especially on immunocompromised patients. The diagnosis is mainly clinical. The treatment is medico-surgical and must start as soon as the diagnosis is made to avoid complications. We report a case of an abscess of the nasal septum responsible for facial cellulitis in 45-year-old diabetic patient. Her diabetes was irregularly followed. The septal abscess spread over a few days to the tissues of the face. He was received in a picture of impaired general condition with significant facial oedema. He received rapid and appropriate medical and surgical car. He progressed well under treatment after 15 days.

The Pathophysiology of Cellulite: Can the Puzzle Eventually Be Solved?

The pathophysiology of cellulite is still largely unknown. Here, we propose a new pathophysiology that connects the development of cellulite with several newly-discovered hallmarks of white adipose tissue. According to this theory, cellulite appears in hypertrophic fat tissue that is associated with overproduction of low molecular weight hyaluronan (HA). This can induce different types of fibrosis, producing inhomogeneous spatial tension in the tissue. This pathophysiology serves to explain the most well known peculiarities of cellulite appearance as well as to formulate the theoretically optimal cellulite treatment strategy.

A Clinical and Histological Study of Radiofrequency-Assisted Liposuction (RFAL) Mediated Skin Tightening and Cellulite Improvement <br>——RFAL for Skin Tightening

Background: A novel Radiofrequency-Assisted Liposuction (RFAL) technology was evaluated clinically. Parallel original histological studies were conducted to substantiate the technology’s efficacy in skin tightening, and cellulite improvement. Methods: BodyTiteTM system, utilizing the RFAL technology, was used for treating patients on abdomen, hips, flanks and arms. Clinical results were measured on 53 patients up to 6 months follow-up. Histological and biochemical studies were conducted on 10 donors by using a unique GREDECO model of skin fragments cultured under survival conditions. Fragments from RFAL treated and control areas were examined immediately and after 10 days in culture, representing long-term results. Skin fragments from patients with cellulite were also examined. Results: Gradual improvement in circumference reduction (3.9 - 4.9 cm) and linear contraction (8% - 38%) was observed until the third month. These results stabilized at 6 months. No adverse events were recorded. Results were graded as excellent by most patients, including the satisfaction from minimal pain, bleeding, and downtime. Histological analysis of skin fragments immediately following RFAL treatment showed hypodermal coagulation of fat and blood vessels, and structural changes in dermal fibers. After 20 days in culture, fibroblast fibers metabolism was stimulated. Histological changes following cellulite treatment were also noted. Conclusions: The novel RFAL technology offers immediate skin tightening effect that is stable over time. The histological results correlated with the clinical observations of circumference reduction and skin tightening, as expressed by tissue fibers modulation. Moreover, RFAL offers an effective treatment for cellulite by formation of a thick collagen band at the dermal-hypodermal junction.

Multi-channeling optimized radiofrequency energy: A new age in well-established radiofrequency technology

AIM To evaluate the safety and efficacy of Viora's new multipolar radiofrequency(RF) handpiece. METHODS A group of twelve volunteers(11 females and 1 male) participated in the current study, ranging in age from 23-70 years with Fitzpatrick skin type Ⅱ-Ⅴ. The inclusion criteria for the enrollment were no contraindications for the treatment, body mass index(BMI) < 35 and local fat accumulation or cellulite formation. A total of 19 treatment areas were treated in the study: 9 abdomen, 2 abdomen plus flanks, 2 arms and 6 thighs. The treatment performed with new multi-polar RF handpiece(V-FORM) with 4 levels of RF power(up to 50 W), 4 levels of vacuum pressure intensity(up to 500 mbar) and 4 operational modes(0.8, 1.7 and 2.45 MHz). Circumferential reduction and cellulite reduction treatments were performed once a week(7 ± 1 d) for a treatment series of 3-8 sessions. The clinical assessment of the treatment outcomes included skin moisture level, skin impedance, body temperature, circumferential measurements, clinical photographic assessment and BMI. RESULTS Ten of twelve patients completed the treatment course. No side effects were recorded during the study. The skin responded with slight erythema and sometimes edema, which is considered a positive end-point. All patients maintained a stable weight during the entire period of the study. No patient underwent any treatments or took medications for fat volume reduction during the study. A moderate positive correlation was found between the patient's age and BMI(correlation coefficient 0.54). The initial body temperature increased in average to 34.0 ℃ from 31.9 ℃, the initial skin moisture level increased to an average 40.98% from 38.9% and the initial skin impedance decreased by 3.8%-35.9% by the end of the treatment course. The pre-heating time for all body areas ranged between 1-6 min with negative correlation to the body's end-point temperature(correlation coefficient-0.31). All patients responded to the treatment and showed some degree of circumferential reduction(up to 15 cm), on at least one of two-three measured points. CONCLUSION According to clinical data collected in this study, the new V-FORM handpiece represents an effective treatment with 100% response rate, with the safest treatment profile.

The High Frequency (HF) Ultrasound as a Useful Imaging Technique for the Efficacy Assessment of Different Anti-Cellulite Treatments

The purpose of the research was to evaluate the role of high frequency ultrasound in monitoring and efficacy assessment of anti-cellulite treatments. A group of 66 women used 3 different types of anti-cellulite treatments;additionally a placebo group (n = 18) was created. The μ-Scan ultrasound device with a 35 MHz mechanical probe was used for the examinations. The following parameters were subjected to the ultrasound evaluation: epidermis thickness, dermis thickness, dermis echogenicity, the length and area of subcutaneous tissue bands projecting into the dermis (dermis-hypodermis junction), as well as the presence/absence of edema within the dermis. As a result of anti-cellulite treatment, the length and area of dermis-hypodermis junction significantly decreased, and dermis echogenicity significantly increased. Ultrasound imaging made it possible to evaluate the efficacy of the applied treatments. The high frequency ultrasound is a useful imaging technique for the application in aesthetic dermatology and cosmetology.

Retrospective Analysis of Treatment Results by Non-Invasive Radiofrequency (RF) Device with Standard and High Voltage RF Electrical Pulses Coupled with Suction for Fat Reduction and Cellulite Improvement

Introduction: The growing demand for non-surgical, non-invasive procedures for fat and circumference reduction and for cellulite treatments has led to the development of various energy-based technologies. Bi-polar radiofrequency (RF) technology combined with additional technologies, such as vacuum, massage or infrared (IR) light is widely used in various body contouring treatments in the medical aesthetic market. The current study is based on a retrospective efficacy analysis of an RF device, combining two RF modalities, coupled with suction. Methods: Representative treatment outcomes, documented in photographs taken at baseline and post-treatment were gathered from several clinics. Photos of the various treatment areas were evaluated by independent evaluators for cellulite and contour improvement. Results: Before and after photographs were gathered from 31 patients treated in different clinics. Analysis was carried out on different body areas such as thighs, abdomen, back, buttocks and arms and analyzed by two independent evaluators. Scoring was performed according to the Global Aesthetic Improvement Scale (GAIS) scale and indicated an overall improvement in the contour of all treated body areas. In cellulite cases, improved appearance according to the cellulite grading scale was noted. Conclusion: This retrospective analysis supports the device’s efficacy for fat and circumferences reduction and cellulite improvement. The device’s unique specifications contribute to treatment safety and efficacy which is highly tolerable by the patients.