Radio frequency hyperthermia system for skin tightening effect by filled waveguide aperture antenna with compact metamaterials.

Radio frequency (RF) hyperthermia focuses on raising the target area temperature to a value exceeding 45°C. Collagen is stimulated when the temperature rises to 45°C at the dermal layer, resulting in skin tightening. However, most studies on RF hyperthermia have focused on tumor ablation or using electrodes to radiate an electromagnetic field, which is highly inefficient. This study proposed a non-invasive RF hyperthermia skin-tightening system with a compact metamaterial-filled waveguide aperture antenna. The proposed RF system increased the temperature by 11.6°C and 35.3°C with 20 and 80 W of 2.45 GHz RF power, respectively, within 60 s and exhibited a very focused effective area. Furthermore, a metamaterial was proposed to reduce the size of the waveguide aperture antenna and focus the electromagnetic field in the near-field region. The proposed metamaterial-filled waveguide aperture antenna was compact, measuring 10 mm × 17.4 mm, with a peak gain of 2.2 dB at 2.45 GHz. The measured hyperthermia performance indicated that the proposed RF system exhibited better power- and time-efficient hyperthermia performance than other RF hyperthermia systems in the cosmetic skin lifting commercial market. The proposed RF hyperthermia systems will be applied into a new generation of beauty cosmetic devices.

Safety and Efficacy of High-Intensity Focused Ultrasound and Monopolar Radiofrequency Combination Therapy for Skin Tightening: A Retrospective Study in Malaysia.

Background: High-intensity focused ultrasound (HIFU) and monopolar radiofrequency (MRF) are common treatment modalities that have shown significant results in skin tightening. Nevertheless, the novel combination of these two treatments is new to the Malaysian landscape. Thus, this study aims to investigate the safety and efficacy of this novel combination treatment for the Malaysian population. Methods: This retrospective study included data on HIFU and MRF combination therapy for skin tightening collected from an aesthetic clinic in Johor Bahru, Malaysia from June 2018 to May 2021. Efficacy was assessed using the Global Aesthetic Improvement Scale (GAIS) and Glogau classification, while the safety of the treatment was analysed using pain scores and adverse events (AEs). Results: A total of 56 patients with a mean age of 47.7 years old (SD 10.00) were included in this study. The majority of the patients had Fitzpatrick skin types III and IV. Most of the patients were Chinese, followed by Malay, Indian and others. Most patients (96.4%) showed clinically significant improvement in skin tightening after treatment, with 15 patients scoring 1 (very much improved) and 39 scoring 2 (improved). All patients reported transient mild erythema, with no serious AEs, such as burn, swelling, numbness or muscle weakness. Among the patients, 80% reported a pain score of 5, while 10% reported pain scores of 4 and 6. Conclusion: Combining HIFU with MRF therapy improved GAIS scores by 96.4%, indicating a secure and efficient skin-tightening method. Transient erythema was shown to be the most common side effect of this combination.

Vectorized facial skin tightening: A study on the Thermal Thread Technique™ utilizing high-intensity, high-frequency, parallel ultrasound beam.

BACKGROUND: Facial skin tightening with wrinkle/fine line reduction is a highly demanded procedure in the aesthetic field. Although there are studies focused on the types of energy sources, the total amount of thermal energy, and the affected depth, there have been no reports examining the relationship between the shape of thermal energy and the directivity of skin tightening. We have developed a specific method to apply thermal energy to the dermis in continuous parallel lines, resembling a thread, perpendicular to the Relaxed Skin Tension Lines (RSTL) for vectorized collagen contraction using synchronous ultrasound parallel beam technology. OBJECTIVE: To evaluate the safety, tightening capability, and directivity of the Thermal Thread Technique™ utilizing a high-intensity, high-frequency, parallel ultrasound beam. MATERIALS AND METHODS: A total of 34 cases, both males and females aged between 30 and 70 years with Fitzpatrick skin types 2-4, exhibiting mild to moderate skin laxity, participated. All subjects received one treatment using the Thermal Thread Technique™ utilizing high-intensity, high-frequency parallel ultrasound beam to cover the full face and submental area. 3D clinical images were captured before, 8 weeks, and 24 weeks after the treatment. A quantitative image analysis of captured 3D images was performed to objectively measure the direction and distance of contraction. RESULTS: The average contraction distance from baseline (0 mm) to 8 weeks and 24 weeks posttreatment were 1.91 ± 0.61 mm (p < 0.001) and 1.96 ± 0.67 mm (p < 0.001) respectively. Regarding the contraction direction at 24 weeks posttreatment, the angle formed between the contraction direction and the base axis, which is perpendicular to the RSTL, was + 9.85° ± 32.94°. Out of 34 cases, 28 met the criteria with the angle within ±22.5° of the base axis (p < 0.001). The average pain score on a 0-5 scale (0 being no pain, and 5 being maximum pain) was 2.63 ± 0.78. No side effects were reported during the treatment or observation period. CONCLUSION: The Thermal Thread Technique™ utilizing a high-intensity, high-frequency, parallel ultrasound beam was proven to be clinically safe and effective for vectorized facial skin tightening.

Efficacy and safety of high-intensity, high-frequency, non-focused ultrasound parallel beams for facial skin laxity.

BACKGROUND: Ultrasound energy has been used for dermal rejuvenation to treat fine lines, wrinkles and to lift lax skin. High intensity ultrasound waves induce thermal injury in the dermis, stimulating neocollagenesis and neoelastinogenesis. OBJECTIVE: To assess the efficacy, utility, and safety of a novel ultrasound device that uses high-intensity, high-frequency, non-focused ultrasound parallel beams to lift lax facial skin in the eyebrow, submental, and neck areas. MATERIALS AND METHODS: Fifteen subjects aged 40-69 years were enrolled in a prospective clinical trial. Two treatment sessions were performed with the high-intensity non-focused ultrasound parallel beam device followed by 3- and 6-month follow-up visits. Treatment results were assessed by study investigators, evaluating baseline and posttreatment photographs by applying physician global aesthetic improvement scale. Pain was evaluated immediately after each treatment using 0-10 visual analog scale. Any adverse event that occurred during the study period was documented and examined. RESULTS: Fifteen subjects with a mean age of 55 ± 2 years completed the study. Photographs that were taken at baseline and follow-up visits were compared and examined. An improvement pattern was detected in all treated areas in both follow-up visits and persisted stably throughout the study. The mean pain score was 5.6 according to the visual analog scale. CONCLUSION: The novel ultrasound device that uses high-intensity, high-frequency, non-focused ultrasound parallel beam was shown to improve safely and efficiently facial lax skin resulting in eyebrow, submental, and neck skin lift while experiencing tolerable pain.

Focused Ultrasound for Dermal Applications.

Focused ultrasound (FUS) is emerging as one of the most promising, non-invasive treatment techniques. The advancement of transducer technology has paved the way for dermatological applications. A comprehensive review is presented for healthcare practitioners and researchers, summarizing the effect of various operational parameters on the injury zone produced by ultrasound beams for various dermatological applications, which include skin tightening, fat reduction, hyperpigmentation and cancer treatment. In this article, we aim to highlight the efficient operational parameters of FUS to enhance pain relief during surgery and its affordability for skin treatment. Finally, a prospective future technique for efficient FUS is discussed.

Effect of geometric parameters of electrodes on skin heating for the design of non-ablative radiofrequency device.

BACKGROUND: Non-ablative radiofrequency (RF) has been widely used in clinical and at-home cosmetics devices. RF electrode geometry can influence the heat distribution in the tissue. This study analyzes the influence of geometric parameters of the electrode on the heat distribution in the layered tissue. MATERIALS & METHODS: The finite element simulation of the electrothermal coupling field was performed to obtain the three-dimensional (3D) temperature distribution of the four-layer tissue. The electrode geometric parameters including the inter-electrode spacing (5-12 mm), width (1-3 mm), length (3-10 mm), shapes (bar, dot and circle), and the coupling gel's electrical conductivity (0.2-1.5 S/m) were simulated. The maximum temperature at 2 mm depth (T-2 mm ) and the temperature difference (Tdiff ) between the maximum skin surface temperature and T-2 mm were obtained to evaluate the effectiveness and safety. RESULTS: The effect of geometric parameters on the effectiveness and safety was mixed. The maximum T-2 mm occurred with the 5 mm inter-electrode spacing, 3 mm width, 10 mm length, the circle-shaped electrode, and the 1.5 S/m coupling gel's electrical conductivity. The ratio of inter-electrode spacing to width at around four can achieve rapid temperature rise and skin surface temperature protection. The electrode shape influenced the area of temperature rise in the tissue's cross-section. The coupling gel's electrical conductivity should be close to that of the skin to avoid energy accumulation on the skin surface. CONCLUSION: The electrode's geometric parameters affect the effectiveness and safety of the RF product. This study has provided the simulation procedure for the electrode design.

Ultrasound Therapy for the Skin.

Ultrasound energy is delivered to the dermal and subdermal tissue to induce thermal injury, leading to collagen remodeling and resulting in lifting and tightening of the skin. Ulthera and Sofwave are two Food and Drug Administration-approved systems that have demonstrated clinically significant results in providing eyebrow, submental, and neck lift and minimizing facial fine lines and wrinkles. Patient selection and management of expectations are important components to a successful treatment process. Both devices boast high patient satisfaction rates, minimal recovery time, and excellent safety profile. Ultrasound technology is an effective, nonsurgical option for facial rejuvenation.

[New technologies for noninvasive aesthetic treatments]. / Neue Technologien für nichtinvasive Therapien in der ästhetischen Medizin.

In recent years, the demand for noninvasive aesthetic treatments has increased significantly. New systems and technological innovations open new possibilities for practitioners and patients in the field of body contouring, noninvasive face lifting, skin tightening and rejuvenation, as well as effective therapies for urinary incontinence or erectile dysfunction. Currently, the most well-known innovations include technologies such as high-intensity focused electromagnetic field (HIFEM™) and radiofrequency (RF), which, after more than 30 years of research, could be combined in the RF-SYNCHRODE™ (BTL Medizintechnik GmbH, Prague, Czech republic) without any health risks for the patient. This allows the reduction of adipose tissue and the building of muscle in a single treatment. The newer HIFES™ technology was developed specifically for the treatment of the facial area and facial muscles. It is used with synchronized radiofrequency for noninvasive, painless face lifting and skin tightening, and is also suitable for botulinum toxin patients. Visible, noticeable, and long-lasting treatment results are achieved without significant side effects after only 4-6 sessions. These noninvasive, FDA(Food and Drug Administration)- and CE-certified systems are used in everyday practice and clinical routine in dermatology, gynecology, urology, and physiotherapy and represent a real alternative to invasive aesthetic plastic surgery.

[Microfocussed vs. macrofocussed ultrasound for body contouring]. / Mikro- versus makrofokussierter Ultraschall zum Bodycontouring.

Focussed ultrasound is capable of heating tissue in small microscopic areas up to 65-70 °C and is a technique that can be used not only for destruction of superficial tissue but also for fat reduction. The focussing of sound waves according to the principle of a bundling of rays is carried out without injury to the skin. The penetration depth of the coagulation depends on the wavelength. Wavelengths that reach penetration depths of 6mm, 9mm and even 13mm and therefore deeper layers of the dermis and fat tissue are new. These enable fat cells to be eliminated and ultimately lead to girth reduction and also additionally to tightening. The effectiveness has been confirmed by several studies.

[Radiofrequency : Monopolar, bipolar, multipolar and fractional]. / Radiofrequenz : Mono-, bi- und multipolar sowie fraktional.

In addition to the laser technology, other physical methods are increasingly being used for medical and therefore medical cosmetic purposes. The most frequently used energy sources include the various application forms of radiofrequency (RF). The aim of the use of RF is to vaporize and coagulate tissue through a tissue temperature of >70 °C and to achieve a temperature of 42-44 °C especially in deeper layers, in order to promote a thermally induced collagen regeneration that enables skin tightening over the dermis. Unipolar, monopolar, bipolar, multipolar and fractional RF are suitable for medical applications. The result to be expected cannot compete with surgical lifting but RF is effective in cases of moderately sagging skin.

Combined Monopolar Radiofrequency and Targeted Pressure Energy for the Treatment and Improvement of Cellulite Appearance on Multiple Body Parts.

Background: With many treatments available for managing cellulite, non-invasive procedures are increasingly sought after. Radiofrequency (RF) and targeted pressure energy (TPE) are new techniques developed to counter aesthetic signs of aging. The combination of RF and TPE for cellulite thus requires a more robust investigation. Objective: We sought to determine the effectiveness and safety of combined/simultaneous RF and TPE for skin tightening and reducing the appearance of cellulite. Methods: Thirty subjects aged 46.5±9.0 (31-74) years, BMI 19.8-36kg/m2 were enrolled and treated for cellulite on the hips, thighs, abdomen and arms. Each subject received four treatments, over 2 to 4 consecutive weeks. The circumference of the treated areas was measured at baseline, after the final treatment session, and at follow-up visits one month, three months and six months following treatment. The efficacy of the therapy was evaluated based on the Cellulite Severity Scale, Global Aesthetic Index Scale, and the Subject Satisfaction Questionnaire. Occurrence of side effects and adverse events was monitored, therapy comfort was analyzed. Results: Cellulite severity improved from moderate to mild cellulite (p<0.001) in 95 percent of patients. Blinded, independent, evaluators reported aesthetic improvement in 90 percent of subjects. Significant circumference decrease in the abdomen, hips, and thighs was observed six months after treatment (p<0.01). Eighty-six percent of subjects were satisfied with improved cellulite appearance, and 82 percent of patients reported improved skin laxity. No severe side effects or adverse events occurred. Conclusion: The simultaneous TPE+RF procedure was able to non-invasively improve cellulite appearance in the majority of subjects and may be recommended for skin tightening on various body parts.

Nonsurgical Rejuvenation of the Neck.

Nonsurgical skin tightening in the neck is an area of significant growth with seemingly countless devices. Optimal treatment choice depends on the patient's concerns, anatomy, and lifestyle. Patients with minimal skin laxity, but dynamic platysmal bands may benefit from botulinum toxin injections. Mild to moderately lax skin can be addressed with microfocused ultrasound or radiofrequency with microneedling. Significant sun damage and laxity can both be addressed with fractional ablative lasers. Options for submental preplatysmal fat include percutaneous radiofrequency, radiofrequency-helium plasma, deoxycholic acid injections, and cryolipolysis. Of these, percutaneous radiofrequency has the highest patient satisfaction and lowest complication rate.

Histological effects of a combined collagen stimulation procedure consisting of microfocused ultrasound, soft tissue filler, and Ca-HA injections.

BACKGROUND: An increasing demand for in-office aesthetic procedures aiming to improve collagen stimulation has been reported. OBJECTIVE: To analyze the effects of combinations of different aesthetic collagen stimulation procedures using histological analysis. METHODS: Histological analysis was performed on skin samples of the excess skin of a 60-year-old patient after sub-superficial musculo-aponeurotic system facelift surgery. The excess skin before facelift surgery was divided into three areas per hemiface. Each area-with exception of area A as a control-received an isolated or combined treatment of microfocused ultrasound (MFU), injections of calcium-hydroxylapatite/hyaluronic-acid-based soft tissue filler, and microneedling. The effect of the treatments was analyzed using histological analysis with H&E coloration and PAS staining. RESULTS: A threefold increase of epidermal and dermal thickness was achieved by treating the skin with the proposed combined treatment comprising MFU and injections of calcium-hydroxylapatite- and hyaluronic-acid-based soft tissue fillers. CONCLUSION: The investigated treatments act synergistically in the production of collagen and combining these treatments allows for an increase in collagen production.

The efficacy and safety of the high-intensity parallel beam ultrasound device at the depth of 1.5 mm for skin tightening.

BACKGROUND: High-intensity parallel beam ultrasound (US) is a novel device equipped with Synchronous Ultrasound Parallel Beam (SUPERB) technology applied in anti-aging treatment. The system is aimed at pathways stimulating neocollagenesis and neoelastinogenesis in the dermis leading to skin tightening and rejuvenation. AIMS: Evaluate the efficacy and safety of the high-intensity parallel beam US device at the depth of 1.5 mm for skin tightening treatment. METHODS: Thirty-six participants were enrolled in the study. Digital photographs and Antera 3D photographs were taken at baseline, 1 and 3 months post-treatment. The depression volume of nasolabial folds (NLFs) and marionette lines (MLs) in each visit was evaluated using Antera 3D imaging program. Pain was evaluated by pain measurement scales immediately after treatment. Any procedure related side effects were documented and examined. RESULTS: Post-treatment results were compared to the baseline; statistically significant mean depression volume (MDV) change of NLFs and MLs were found at 1 and 3 months post-treatment. No significant MDV change from 1 to 3 months post-treatment could be demonstrated. The mean pain score was 6.64 on a 0-10 scale. No adverse events were reported. CONCLUSIONS: Our study demonstrates that the novel high-intensity parallel beam US device is clinically safe and effective for skin tightening in the lower face area. We noticed a reduction in NLFs and MLs in more than 60% of our participants already as early as 1 month post-treatment.

A comparative study of pain perception during the microfocused ultrasound procedure between topical anesthesia and combined topical anesthesia with forced air cooling.

BACKGROUND: The experience of pain during microfocused ultrasound with visualization (MFU-V) treatment is common and crucial for dictating patient satisfaction and retention. OBJECTIVE: To compare the pain perception during the MFU-V procedure between two pain reduction methods (topical anesthesia alone versus combined topical anesthesia with forced air cooling). MATERIALS AND METHODS: This was a prospective, single-blinded, randomized controlled trial. A square area on the inner side of both arms of healthy volunteers was marked as an experimental site and randomly assigned to receive each pain reduction method: topical anesthesia or combined topical anesthesia with forced air cooling. Thereafter, MFU-V was performed with a 4.5 MHz, 4.5 mm transducer (10 lines, 0.9 J) followed by a 7 MHz, 3.0 mm transducer (10 lines, 0.3 J). The visual analog scale (VAS) for pain was measured immediately after 4.5 mm transducer (T1a), immediately after 3.0 mm transducer (T1b), and after the entire procedure (T2). RESULTS: Twenty-one participants with a mean (SD) age of 34.67 (±6.18) years were enrolled. The mean (±SD) pain score of combined topical anesthesia with forced air cooling-treated area was 5.40 (±1.64), 4.80 (±1.63), and 5.40 (±1.56) at T1a, T1b, and T2, respectively. The mean pain score for topical anesthesia-treated areas was 5.89 (±1.45), 5.00 (±1.72), and 5.76 (±1.67) at T1a, T1b, and T2, respectively. There were no statistically significant differences in the pain perception between the two methods. CONCLUSION: The addition of forced air cooling is not beneficial for pain reduction during the MFU-V procedure because its temperature reduction effect cannot be delivered to the deep parts of the skin, which is the target site of MFU-V.

The effect of combined of hyaluronic acid dermal filler and microfocused ultrasound treatment: A clinicopathological study.

OBJECTIVES: Microfocused ultrasound (MFU) and hyaluronic acid (HA) filler injection are increasingly popular aesthetic procedures. HA filler injection is generally recommended after MFU if combined treatment is required in a single visit. However, data regarding the safe and optimal time of MFU treatment after HA injection is still limited. The purpose of this study was to evaluate the degree of HA loss when performing MFU treatment after dermal filler injection. METHODS: Fourteen subjects were recruited in this pilot study. HA was injected intradermally on four 2 × 2 cm areas at the abdomen (0.25 ml/site). Site A was served as control whereas site B, C, D were treated with MFU using 1.5 mm transducer at 60 min, Day 14, and Day 28 after the injection, respectively. All experimental sites were biopsied using a 3-mm punch biopsy to evaluate the histopathological profile at baseline and Day 56. Grading of the quantity of retained HA was evaluated by a blinded experienced dermatopathologist. RESULTS: All 14 subjects completed the study. One subject has been excluded due to the poor quality of histopathologic slides. Seven subjects (53.9%) at site B and 6 subjects (46.2%) at site C had HA loss at Day 56 compared with baseline. The mean HA grading at baseline and Day 56 was 3.7 vs. 2.8 (p < 0.001) at site B and 3.7 vs. 3.0 (p = 0.001) at site C, respectively. There was no statistical difference between the mean HA grading at baseline and Day 56 at site D (3.7 vs. 3.3, p = 0.073). No inflammation or granuloma was observed on Day 56 of the study. CONCLUSIONS: MFU treatment after HA injection appears to be safe. However, some degree of HA loss was observed if MFU treatment was done within 2 weeks after HA injection.

Efficacy and Safety of Monopolar Radiofrequency for Treatment of Lower Facial Laxity in Asians.

INTRODUCTION: Monopolar radiofrequency (MRF) is a valuable modality for tightening and contouring mild-to-moderate facial skin laxity. Few studies have evaluated new-generation MRF devices for lower facial laxity in Asians. This study aims to evaluate the efficacy and safety of MRF for treating lower facial laxity in Asians. METHODS: This prospective cohort study enrolled 30 volunteers with Fitzpatrick Skin Types III-V and mild-to-moderate skin laxity. Subjects received a single MRF treatment. Self-assessments and adverse events were recorded. Two blinded dermatologists graded improvements (6-point scale) after treatment and 1, 3, and 6 months later. RESULTS: All subjects completed the study. Treatment energy levels ranged from 2 to 4. The average number of shots was 412 ± 49, delivered in 3-4 passes with 15-30% overlap. All patients reported improvement in lower facial laxity immediately after treatment. Most patients had mild-to-moderate improvement over the 6-month follow-up. Continuous improvement was observed at the 1-, 3-, and 6-month follow-ups (P < 0.01). Significant improvement was seen at the 6-month follow-up compared with the 1-month follow-up (P < 0.01). Subjects tolerated the procedure well: the average pain score was 3.13 out of 10, and no serious adverse events were observed. CONCLUSIONS: The new-generation MRF device we tested was effective and safe for mild-to-moderate lower facial laxity in Asian skin. The latest MRF technology offers improved safety to prevent complications. Appropriate patient selection, setting, and protocols are mandatory to achieve optimal clinical outcomes. THE TRIAL REGISTRATION NUMBER: TCTR20210326002.

Nonsurgical Rejuvenation of the Neck.

Nonsurgical skin tightening in the neck is an area of significant growth with seemingly countless devices. Optimal treatment choice depends on the patient's concerns, anatomy, and lifestyle. Patients with minimal skin laxity, but dynamic platysmal bands may benefit from botulinum toxin injections. Mild to moderately lax skin can be addressed with microfocused ultrasound or radiofrequency with microneedling. Significant sun damage and laxity can both be addressed with fractional ablative lasers. Options for submental preplatysmal fat include percutaneous radiofrequency, radiofrequency-helium plasma, deoxycholic acid injections, and cryolipolysis. Of these, percutaneous radiofrequency has the highest patient satisfaction and lowest complication rate.

Contemporary Management of Gynecomastia.

Contemporary management of gynecomastia includes transareolar excision of gland, disruption of inframammary fold, ultrasonic-assisted lipoplasty with muscular definition, bipolar radiofrequency tightening, pedicled NAC mastopexy with boomerang pattern excision and J torsoplasty, NAC grafts with hockey stick excision pattern, and pectoralis muscle lipoaugmentation. Therapeutic options are arranged across a modified Simon classification. The aesthetic goal is near total glandular reduction, with proper position and shape of the nipple areolar complexes, and masculinity with skin adherence reflecting musculoskeleton. Clinical cases demonstrate these multiple approaches, successes, and pitfalls. Complications relate to delayed healing caused by excessive closure tension or inadequate or inappropriate treatment.

Effectiveness and side effects of bipolar radiofrequency to treat submental laxity.

BACKGROUND: Submental skin laxity becomes a common cosmetic problem with age. Bipolar radiofrequency is a new, non-invasive procedure. Unlike the LASER, the radiofrequency (RF) device has no specific chromophore absorption. Thus, the device can be used on any skin type. OBJECTIVE: To evaluate the effectiveness and adverse effects of the bipolar RF for treatment of submental laxity and skin tightening. MATERIAL AND METHODS: Twenty-two patients with submental laxity were treated with Forma™ on both sides of the submental area. The patients underwent four sessions every 2 weeks for one and half months. Two blinded dermatologists evaluated the pre-treatment and post-treatment photographs at every visit. The three-dimensional photographs were recorded by Vectra® camera and determined the association. RESULTS: All 22 patients completed all the treatment sessions. The degree of improvement was statically significant after the third session based on the physical assessment scale and after the second session in terms of the submental laxity score. The fat volume reduction was statically significant from one week to six months from baseline. Almost all subjects developed transient erythema immediately after the treatment. No serious side effects were noted. CONCLUSIONS: The bipolar RF device is another potential choice for skin tightening due to its efficacy and safety profile. It can be used with any skin type and has few side effects.