Microfocused Ultrasound Research Articles

New Ultherapy method: Utilizing novel surgical and anatomical concepts yields outstanding results.

Micro-focused ultrasound (MFU) is a technique for skin rejuvenation and lifting, targeting the facial SMAS-a fibrous network encompassing the platysma muscle and parotid fascia. This study aims to propose a novel and cost-effective method (suggested by Fatemi) for Ultherapy, comparing its effectiveness with the conventional approach. A prospective double-blind clinical trial was conducted with 30 female volunteers randomly assigned to two groups: The control group (conventional method) and the experimental group (new method). Ultherapy procedures utilized MFU technology with low energy and a higher frequency. Statistically significant differences in lifting effects and improvement in skin laxity were observed between the two groups. The new method, with a focus on the parotideal area of the SMAS, demonstrated superior outcomes and higher patient satisfaction. The parotideal region's accessibility, increased thickness, and safety profile make it an ideal target for Ultherapy. This not only reduces the risk of nerve injury but also yields effective collagen remodeling and skin-lifting results.

53248 Safety and tolerability of Microfocused Ultrasound for people of color

53248 Safety and tolerability of Microfocused Ultrasound for people of color

EMAGRECIMENTO FACIAL COM ULTRASSOM MICROFOCADO MICROPULSADO

This study aimed to evaluate the clinical efficacy of Micro-Pulsed Micro-Focused Ultrasound (Ultraformer MPT®) in reducing facial fat, with a specific focus on the lateral areas of the face. The treatment was conducted on a 55-year-old patient, utilizing three-dimensional stereophotogrammetry with the Vectra H2® software (Canfield) to capture and analyze facial changes 150 days post-procedure. A total of 280 shots were applied with different transducers on the pre-defined areas of the face. The results showed a reduction of 5.09 mL on the right side and 5.62 mL on the left side of the face. The Ultraformer MPT® technology demonstrated to be a safe and effective option for non-invasive facial slimming, with quick recovery and favorable outcomes. This study contributes to the advancement of knowledge on Ultraformer MPT®, establishing a solid foundation for future research and clinical practice.

Ultrasound rejuvenation for upper facial skin: A randomized blinded prospective study.

Growing demand for facial rejuvenation drives advancements in these therapies, including laser, radiofrequency, and focused ultrasound, alongside thermal stimulation adjuncts. These methods, known for stimulating collagen regeneration, skin tightening, and lifting, have gained popularity due to their minimal side effects, low trauma, and high safety, demonstrating favorable outcomes in clinical practice. We sought to assess the efficacy of ultrasound skin tightening for brow lift within the scope of a procedure addressing facial sagging across the entire face. Our aim was to explore a noninvasive method capable of effectively enhancing mild to moderate brow ptosis by tightening and lifting the skin in the upper facial region. This was a rater-blinded, prospective cohort study. The upper facial region of the participants was treated with the new device, micro-focused ultrasound (MFU), in model D3.0/D2.0/M3.0. Outcomes of brow lift were measured in comparison of pretreatment and posttreatment photographs and three-dimensional (3D) vector analysis. A total of 42 participants (37 females) were enrolled, with 2 participants withdrawing from the trial, resulting in 40 subjects who completed 180-day-follow-up and evaluation. 35 (87.5%) were deemed to have clinically significant brow elevation by two blinded assessors (experienced clinicians) at 180-day posttreatment (p < 0.01). The mean change in brow height after 90-day was 2.16 ± 0.63 mm at the frontal position (straight-ahead gaze) (p < 0.01). The 3D vector analysis reveals varying magnitudes of vector displacement in the upward and outward directions of the skin on the frontal region above the eyebrows. Focused ultrasound appears to be a safe and effective method for upper facial skin rejuvenation. A single focused ultrasound treatment on the forehead and temple areas resulted in an average brow elevation of 2.1 mm.

Histological Changes of Porcine Animal Skin with Micro-focused Ultrasound.

As a noninvasive alternative therapy, microfocused ultrasound (MFU) has become a research hotspot in recent years for its potential to enhance skin laxity. While several clinical studies have explored the effects of MFU on improving skin laxity, there is limited literature available on the histological changes resulting from MFU treatments. It has been established that the skin structure and composition of the Bama miniature pigs closely resembles that of humans, including collagen content, type I collagen distribution, and elastin distribution. This study primarily focuses on examining the histological alterations in the skin tissue of Bama miniature pigs following MFU application. We also selected some typical clinical photographs of patients treated with MFU and compared the clinical effects with histological changes observed in porcine skin. The MFU device utilized in this study incorporates ultra-pulse technology and large focal area technology. Following the standard operating procedures provided by the manufacturer, different handles were used in different skin area of pigs. Biopsies were obtained immediately after treatment and 1 month after treatment. Significant histological changes were observed in the Bama miniature pigs skin, including collagen contraction and fragmentation, dilation and congestion of superficial dermal capillaries immediately after MFU treatment; dermal thickening, increased thickness and density of collagen fibers, elevated levels of elastin and type I collagen, as well as thickened fiber septa in the adipose layer 1 month later. These histological results corresponded to clinical findings in human, such as facial redness and swelling immediately after treatment, and improvement in facial relaxation after approximately 1 month after treatment. Collectively, these histological findings provide valuable evidence supporting the clinical application of MFU for enhancing skin laxity. This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

ASSOCIATION OF SCULPTRA WITH MICROFOCUSED ULTRASOUND FOR FACIAL REJUVENATION

With the increasing demand for an improvement in the appearance of the skin, technologies have advanced more and more each day, providing excellent visible and lasting aesthetic results in facial rejuvenation. A procedure that is currently in great demand and has proven to be effective is poly-L-lactic acid - Sculptra, an injectable collagen bio-stimulator that offers a non-surgical alternative with minimally invasive techniques that promises to improve and consequently delay skin aging. Another device that offers non-invasive therapy, indicated for facial lifting, sagging treatment and reduction of localized adipose tissue is the Microfocused Ultrasound – Ultraformer III. The work briefly addressed skin aging for a better explanation and aims to evaluate the effectiveness of the association of poly-L-lactic acid – Sculptra with Microfocused Ultrasound – Ultraformer III in a case study with two applications over a period of 60 days. Each of these biostimulators mentioned has certain attributes, providing an improvement in the appearance and characteristics of aging. In view of this, the sum of the two techniques demonstrates positive results according to stereographic analysis with the 3D Vectra H2 software and appropriate according to the anamnesis and problems presented by the patient.

Pilot Study of Microfocused Ultrasound, Incobotulinum Toxin, and Calcium Hydroxyapatite in Triple Therapy for Skin Tightening after Weight Loss

Pilot Study of Microfocused Ultrasound, Incobotulinum Toxin, and Calcium Hydroxyapatite in Triple Therapy for Skin Tightening after Weight Loss

44057 The Effectiveness of Using Triple-Combined Modalities using Microfocused Ultrasound, Neuromodulators and Fillers in the Periorbital Region for Optimal Rejuvenation: A Prospective Cohort Study

44057 The Effectiveness of Using Triple-Combined Modalities using Microfocused Ultrasound, Neuromodulators and Fillers in the Periorbital Region for Optimal Rejuvenation: A Prospective Cohort Study

ASSOCIATION OF MICROFOCUSED ULTRASOUND AND POLY-L-LACTIC ACID AS COLLAGEN BIOSTIMULATORS

Facial aging is a gradual process that involves a complex interaction of several factors, including loss of subcutaneous volume, deep bone resorption and tissue laxity. To promote rejuvenation, it is extremely important to restructure the multiple layers of the face, initially by inducing collagen synthesis and tissue contraction. Thus, the combination of Poly-L-lactic Acid and Microfocused Ultrasound has proven to be increasingly effective for treating flaccidity and as a collagen biostimulating technique. This study carried out a stereophotogrammetric analysis with the 3D Vectra H2 software of a clinical case of association of Microfocused Ultrasound (Classys) with Poly-L-lactic acid (Sculptra - Galderma) at the beginning of the treatment and 60 days later.

MICROFOCUSED ULTRASOUND FOR FACIAL LIFTING AN INNOVATIVE TREATMENT PROPOSAL

Introduction: several studies report the contraction or retraction of facial tissues with the use of “High-Intensity Focused Ultrasound” (HIFU). However, there are no studies or clinical trials on the technical possibilities used in the application of technology to promote face lifting. Objective: to evaluate the clinical efficacy of a new technique for applying Reface Microfocused Ultrasound in the middle third of the face for face lifting. Material and method: the study involved a sample of n=05 patients aged between 30 and 65 years who were evaluated pre and postoperatively, with stereophotogrammetry and its analysis in the Vectra software that were treated with Reface Microfocused Ultrasound with 4.5mm transducers and 3.0mm with focal depths used with average amounts of 0.9 Joules and 0.7 Joules on average and respectively for different transducers used, with an identical positioning protocol, number of lines of application, sequence of application of lines and zones start and end of application. Results: the sample of n=05 (five) patients completed the study. A face-lift was obtained based on the evaluation carried out using the stereophotogrammetry method, which indicated vectors suggestive of tissue contraction and retraction and consequent face-lift in the patients involved in the study, which was maintained for the observation period of 5 months, which was promoted by the new application technique of Reface Microfocused Ultrasound. Conclusion: the quantitative data obtained by comparing before and after with Vectra system, demonstrated that this new technique of application of Ultrasound Microfocused Reface is an effective procedure to treat flaccidity and provide facial “lifting”.

A Systematic Review and Meta-Analysis of the Clinical Efficacy and Patients' Satisfaction of Micro-focused Ultrasound (MFU) Treatment for Facial Rejuvenation and Tightening.

Micro-focused ultrasound (MFU) is commonly used to improve facial relaxation and wrinkles. The objective of this study was to determine the efficacy of MFU for facial rejuvenation and patients' satisfaction with the treatment. Articles published before December 2022 were retrieved using PubMed, Embase, Web of Science, and Cochrane Library databases. The retrieved literature was screened according to strict criteria, and the risk of bias of each study was assessed. A total of 13 MFU studies for facial rejuvenation and tightening were included, involving 477 participants. Efficacy was assessed using the Global Aesthetic Improvement Scale (GAIS), and meta-analysis showed an overall response rate of 0.77 (95%CI: 0.58, 0.96) at 90 days after intervention and 0.69 (95%CI: 0.51, 0.87) at 180 days. 0.78 (95%CI: 0.61, 0.95) and 0.71 (95%CI: 0.54, 0.87) patients were satisfied and very satisfied overall at 90 days and 180 days, respectively. The pain score was on a 10-point scale, and the overall score was 3.10 (95%CI: 2.71, 3.94). There were no instances during treatment where patients could not tolerate pain. Sensitivity analysis showed that the results were robust. In conclusion, MFU is an effective way to treat facial rejuvenation and tightening. More large-sample, multicenter and randomized studies are needed to determine the optimal treatment parameters in the future. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Handheld microfocused ultrasound device for facial lifting: A preliminary study of ULTIGHT.

Although focused ultrasound modalities have achieved positive clinical results in noninvasive skin rejuvenation, they presented various side effects and particularly severe pain during treatment. This study introduces a microfocused ultrasound (MFU) device, ULTIGHT, to overcome the severe pain issue, providing quasi-facial lifting. Transducer surface was imaged with a scanning electron microscope. The energies of four treatment cartridges were measured using an ultrasound power meter. In vitro experiments were performed to quantitatively evaluate the MFU thermal zones (MFUTZs) and treatment line (TL) of 10 MFUTZs. Ex vivo experiments were performed to evaluate the MFUTZs and temperature rise in tissue. Clinical trials using eight volunteers were performed to qualitatively evaluate facial lifting. The MFU transducer clearly showed a smooth and no air gap surface. ULTIGHT produced 10 discrete MFUTZs in a TL of length 10 mm. In ex vivo tissue, discrete linear MFUTZs were clearly observed at lower number of TLs; however, they started to aggregate at higher number of TLs. The temperature rise was linearly increased as a function of the number of treatments. A single MFUTZ resulted in a temperature rise of 3°C-10°C that could cause hyperthermia for body temperature. In the clinical trials, the volunteers showed quasi-facial lifting right after treatment on the lower facial region. ULTIGHT provides relatively low energy, which may be advantageous or disadvantageous depending on clinical applications. Additionally, it has the advantage of being pain-free even without anesthetic during treatment, providing quasi-facial lifting right after treatment.

Treatment Protocol on Using Microfocused Ultrasound with Visualization for Skin Quality Improvement: The Korean Experience.

Facial skin quality profoundly influences an individual's perceived appearance and is an important aspect of facial rejuvenation. Facial pore enlargement is one of the most common concerns among Asian individuals that adversely impacts perceived skin surface evenness and affects overall skin quality. One of the major causes of enlarged pores is facial skin laxity. Microfocused ultrasound with visualization (MFU-V; Ultherapy; Merz North America, Inc., Raleigh, N.C.) is indicated for lifting and tightening of the face and neck, and improving the appearance of wrinkles on the décolletage. In addition, it is useful for addressing several aspects of facial rejuvenation, including facial pores, skin laxity, skin unevenness, etc., but there is limited literature on these applications. Thus, we present our proposed MFU-V treatment protocol for achieving a harmonious outcome for attractive skin, along with practical strategies for its application, illustrated in patients presenting with enlarged pores as their main concern. Drawing on our collective experience in using MFU-V for facial rejuvenation and the recently published skin quality framework that advocates addressing interrelated attributes of skin quality for optimal outcomes, we developed a treatment protocol for improving skin quality using MFU-V. This MFU-V treatment protocol reliably improves overall skin quality in patients presenting with enlarged pores, through MFU-V's effects on skin lifting and tightening, and consequent improvement in facial pores and skin texture. This treatment protocol can be readily used as part of a multimodal layering approach to yield successful outcomes in patients with various facial skin concerns.

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

An increasing demand for in-office aesthetic procedures aiming to improve collagen stimulation has been reported. To analyze the effects of combinations of different aesthetic collagen stimulation procedures using histological analysis. 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. 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. The investigated treatments act synergistically in the production of collagen and combining these treatments allows for an increase in collagen production.

Micro-Focused Ultrasound Therapy in Patients with Urogenital Atrophy and Vaginal Laxity

Vaginal laxity (VL) and genitourinary syndromes of menopause (GSM) create physical, psychological, and functional problem for women and their partners. We aimed to evaluate the efficacy and safety of micro-focused ultrasound (MFU) therapy performed twice in the vaginal canal in a patients with VL and GSM. A total of 20 women with GSM and VL were treated with MFU Ultravera by Hironic. The treatment course consisted of two vaginal applications of MFU at an interval of 6 weeks. The clinical effects of the protocol were evaluated using the Vaginal Laxity Questionnaire (VLQ), the Vaginal Health Index (VHI), and the Female Sexual Function Index (FSFI). The overall values of the vaginal laxity evaluation for the total subject population showed a statistically significant improvement between the baseline and the findings at 3 and 6 months after treatment. The effect of therapy was consistent across all domains of FSFI. It peaked at the 6 week follow-up visit (from 26.5 to 32) and plateaued at 12 weeks and 6 months. There was a significant VHI improvement over time, with the greatest and most significant change between the study entry and 21 days after treatment; the VHI score leveled off up to 3 months after the procedures. MFU therapy, performed twice in the vaginal canal, showed promising efficacy and safety profiles, meriting further investigation.

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

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. Fourteen subjects were recruited in this pilot study. HA was injected intradermally on four 2 × 2cm 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. 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. 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.

Prospective, Single-arm, Split-face Pain Management Evaluation of Nitrous Oxide System During Micro-Focused Ultrasound With Visualization.

Although micro-focused ultrasound with visualization (MFU-V) has great cosmetic results, patients can be hesitant or decline the treatment due to the pain experienced during the treatment. The primary objective is to assess the efficacy of pain management of the nitrous oxide system during MFU-V treatment. The secondary objectives include patient satisfaction and efficacy on reducing facial laxity and improving aesthetic appearance. A prospective, single-arm, split-face, open-label study. Ten patients were treated with MFU-V without use of a self-administered nitrous oxide system on the right side of the face, followed by use of the nitrous oxide system on the left. A patient-reported Visual Analog Pain Intensity Scale was used to assess pain on the right and left sides at 3 different treatment time points. Patient satisfaction was measured using a 5-point Likert scale and efficacy was measured using the Investigator GAIS and the Facial Laxity Score. Clinically significant differences were seen between pain ratings for the treated and untreated sides at 2 of the 3 time points. 100.0% of patients (n=9) who had completed the study were very satisfied (55.6%) or somewhat satisfied (44.4%). Five patients (55.6%) were scored as Improved on the GAIS and 4 patients (44.4%) were scored as Much Improved. 90.00% (n=9) of patients had moderate lower face and neck laxity prior to treatment, compared with 11.11% (n=1) and 22.22% (n=2) with moderate laxity at follow-up. The nitrous oxide system provides clinically significant pain reduction, increases patient satisfaction, and improves cosmetic results of MFU-V treatment. J Drugs Dermatol. 2022;21(11):1228-1234. doi:10.36849/JDD.7030.

A Systematic Review of the Clinical Efficacy of Micro-Focused Ultrasound Treatment for Skin Rejuvenation and Tightening.

The demand for non-invasive skin-tightening techniques is continuously on the rise, as now numerous patients seek safe and effective alternative body, neck, and facial aesthetic surgical procedures. Micro-focused ultrasound (MFU) has been recently introduced as a novel energy modality for skin rejuvenation to produce a more significant wound healing response at various levels, including strong collagen remodeling and long-lasting clinical response. This literature study was intended to find the role and efficiency of using micro-focused ultrasound therapy in male and female patients aged 35-65. A total of 139 articles were extracted from the PubMed and Science Direct electronic databases. After a thorough evaluation and following the exclusion and inclusion criteria, 10 full-text articles were relevant to the study. The goal was to analyze and examine the effects and benefits of MFU treatment to improve the skin. In addition, all of the patients were evaluated to report the harms and risks associated with MFU treatment. The literature study results revealed that significant improvements in the overall aesthetics of sagging of the mid and lower face could be accomplished by using a micro-focused ultrasonic treatment plan. Patients report no considerable side effects, and the results were also long-lasting. MFU treatment can activate deeper tissues without causing injury to the epidermis, which sets it apart from all other skin tightening methods. Better improvements rates have been reported by both patients' self-assessment and clinical investigators' evaluation.

Effect of Microfocused Ultrasound on Facial Rejuvenation: Clinical and Histological Evaluation

Introduction: Micro focused ultrasound (MFU) is formed by mechanical waves emitted in a focused manner, concentrating thermal energy on a certain point or region, promoting a clinical improvement in wrinkles. Objective: evaluate the effects of micro focused ultrasound on facial rejuvenation. Methodology: This is an experimental study. The sample consisted of 30 volunteers, who were evaluated before treatment, 45 and 90 days after its beginning. A single application of the MFU was performed across the facial region. The parameters used were: 10 MHz cartridge with depth of 1.5 mm, 7 MHz with depth of 3 mm, and 4 MHz with focal depth of 4.5 mm; doses ranged from 0.1 to 2.0 J, according to the sensitivity of the volunteers treated, and the application time was of approximately 90 minutes. Clinical photographic analysis and facial symmetry analysis using Dolphin Imaging software were performed, and validated questionnaires. Two volunteers were submitted to blepharoplasty surgery, and one to rhytidoplasty surgery 45 days after the application of the MFU. Samples of the treated skin were taken after the surgical procedures and submitted to histological and immunohistochemical analyses. The volunteers answered a questionnaire to assess adverse reactions and satisfaction. Results: We observed a visible clinical improvement on the images by photography, and an improvement of facial symmetry in the measurements of the paralateronasal projection (p = 0.007), left lateral mandibular (p = 0.01), and right lateral mandibular (p = 0.008). The histological analysis showed an increase in the amount of fibroblasts (p = 0.02), blood vessels (p = 0.0062) and inflammatory cells (p = 0.0036), in addition to the production of type 1 collagen. In the immunohistochemical analysis, we observed the presence of the macrophage marker IHQ: CD68, indicating phagocytosis of adipose tissue and the presence of fibrosis. In the analysis of adverse reactions, only transient hyperemia was observed with the presence of pain during application. Additionally, the volunteers expressed high level of satisfaction (93%) with the treatment Conclusion: The MFU promoted the production of collagen, reorganization of the dermis and, clinically, a reduction of sagging and wrinkles, with increased facial symmetry.

Evaluation of microfocused ultrasound for improving skin laxity in the lower face: A retrospective study.

To evaluate the efficacy and safety of a newer microfocused ultrasound (MFU) device on the lower face laxity. Subjects who underwent MFU therapy for skin tightening were enrolled in the study. The primary outcome measure was overall improvement in skin laxity of the lower face that was evaluated by improvement on jawline irregularities, marionette line, and submental laxity. Assessments were obtained from two blinded dermatologists paired pre- and post-treatment photographs with Investigator-Global-Aesthetic-Improvement-Scale (IGAIS) and from subjects with Subject-GAIS (SGAIS). A total of 24 subjects were evaluated on a median of 4.3 months after 1 session MFU application. According to IGAIS, 5 subjects (20.9%) demonstrated improvement and 15 subjects (62.5%) had no change. Four subjects (16.7%) were scored as worsening. According to SGAIS, 11 subjects (45.9%) reported an improvement whereas 9 subjects (37.5%) reported no change. There was a statistically significant difference between the improvement rate assessed by the investigators and the subjects, where investigators scored lower (P = .006). No serious adverse effects were observed. The relatively high improvement rate observed by the subjects' self assessments compared to investigators evaluation from the photographs suggested that we need to find new evaluation methods other than photography which may reflect what subjects feel but we cannot see.