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.

Effectiveness of combined use of targeted pressure energy, radiofrequency, and high-intensity focused electromagnetic fields to improve skin quality and appearance of fat and muscle tissue in different body parts.

BACKGROUND: Inevitable signs of aging are especially noticeable in middle to elder age when stretch marks, loose skin, cellulite, and body-contour changes naturally appear. AIMS: To verify efficacy of high-intensity focused electromagnetic field (HIFEM), radiofrequency (RF), and Targeted Pressure Energy (TPE) combination treatment to address unfavorable changes in skin, fat, and muscle tissue. METHODS: The device simultaneously emitting monopolar RF and TPE energies was consecutively combined with simultaneous HIFEM+RF procedure in 32 subjects (21-64 years, 17.4-33.5 kg/m2 ) for treatment of thighs (N = 15; back, inner, or front), buttocks/saddlebags (N = 7), abdomen (N = 8), and upper arms (N = 2). All patients underwent four weekly, combined treatments of 30-min HIFEM+RF procedure followed by 15-30 min RF+TPE, depending on treatment area. Circumferential measurements, digital photographs, subject satisfaction, and comfort questionnaires were assessed up to 3-months post-treatment. RESULTS: Majority of participants found treatments comfortable, no adverse events occurred. Subjects showed substantial improvement in all treated areas from 1-month follow-up. Combination of HIFEM+RF, monopolar RF, and TPE resulted in significant circumference decrease. Generally, more pronounced results were seen at 3 months when subjects showed -5.2 cm on abdomen, -3.0 cm on thighs, and -5.5 cm on saddlebags, respectively. Ninety-four percent of subjects were satisfied with treatment results, most noticed improvement in cellulite, skin laxity, and muscle definition. CONCLUSIONS: Results showed high patient satisfaction and efficacy in improving body contour and skin quality. Combining simultaneous HIFEM+RF procedure with simultaneous monopolar RF+TPE treatments considerably enhanced body contour and skin tissue. The procedure proved versatile and may effectively treat multiple body parts.

A New Approach to Thread Facelifting.

BACKGROUND: Facial rejuvenation has traditionally been achieved by repositioning soft tissue via invasive surgery. OBJECTIVES: The present work describes a thread-based, face-lifting (TBFL) technique (BussoLyft™ that has provided reproducible and predictable results for 200 to 300 patients. METHODS: To reposition the orbital, nasolabial, and jowl fat pads, three primary vectors (one vertical, two oblique) are established on the side(s) of the face that requires lifting. The vertical vector for the orbital fat pad is volumetric and the oblique vectors for the nasolabial and jowl fat pads lift by thread-tissue engagement and repositioning. RESULTS: Repositioning the superficial fat pads of the orbital, nasolabial, and jowls areas results in a pleasant cosmetic outcome. In the treated nasolabial and jowl fat pads, the primary repositioning vector results from engaging cogs with fat septa, which places fat in a cosmetically optimal position. The primary mobilization of the superficial fat pad through the septal attachments to the dermis and superficial fascia creates a secondary movement and repositions the overlying skin and underlying superficial muscular aponeurotic system (SMAS). Very few threads are needed to reposition full-face superficial fat. CONCLUSIONS: By optimizing every step of thread placement, the TBFL technique provides an efficient and effective method to reposition facial fat pads. J Drugs Dermatol. 2021;20(10):1085-1090. doi:10.36849/JDD.6139.

High Intensity Focused Electro-Magnetic Technology (HIFEM) for Non-Invasive Buttock Lifting and Toning of Gluteal Muscles: A Multi-Center Efficacy and Safety Study

Objective: Surgical intervention has been the only method to improve the aesthetic appearance of buttocks apart from physical exercising. This study evaluates the efficacy of high intensity focused electro-magnetic (HIFEM) treatments as a non-invasive solution for improvement of buttocks through toning and lifting of gluteal muscles. Materials and Methods: A total of 75 patients (aged 22-59) were treated using a device with HIFEM technology which stimulates gluteal muscles (EMSCULPT, BTL Industries, Boston, MA). The protocol included four 30-minute treatments. Patients' weight was monitored throughout the study. Standard photographs were taken at the baseline, after the 4th treatment, and at the 1-month follow-up. Two 7-point Likert scale questionnaires were used to evaluate patients' buttock and treatment satisfaction. Total score of buttock satisfaction was calculated as a sum of all individual questions to reflect the overall perception of patients' buttocks. The level of comfort during procedures was assessed on a visual analog scale (VAS). Results: The overall buttock satisfaction score (range, 4-28) of all subjects improved from 13.1±5.7 at baseline to 18.4±5.2 after the treatment and 18.9±5.1 at follow-up. For subjects with initial buttock dissatisfaction the scores improved from 8.7±1.6 to 16.3±3.1 after the treatment and to 17.3±3.1 at follow-up. The average score of all treatment satisfaction questions (range, 1-7) was 5.2±1.2 immediately after the treatments and 5.1±1.3 at follow-up. In total, patients initially dissatisfied with the appearance of their buttocks reported a significant 85% improvement after the fourth treatment. Immediately after the fourth treatment, all the subjects reported that their buttocks felt more lifted and toned. Results were maintained at one-month follow-up. Weight of the patients didn't change significantly. Digital photographs showed aesthetic improvements of the buttocks for most of the patients. No adverse events were reported. Conclusion: The results show that the investigated device safely and effectively improves the aesthetic appearance of buttocks non-invasively. The treatments not only resulted in a significant visual improvement but also increased patient confidence and satisfaction. The procedure is suitable for patients seeking improvement in tone, shape, lift, and tightness of the buttocks. J Drugs Dermatol. 2018;17(11):1229-1232.

Hand: Clinical Anatomy and Regional Approaches with Injectable Fillers.

BACKGROUND: Cosmetic physicians are more and more frequently asked for hand rejuvenation. They commonly propose the same techniques as for the face. The authors undertook an anatomical study of the hand dorsum to understand the optimal location for an injected filler and to design the safest technique of placement. METHODS: The first part of the study included dissections of 19 fresh cadaveric hands and duplex ultrasounds investigation of 28 healthy hands. A technique of injection specifically designed from anatomical findings was then tested on 8 fresh cadaveric hands using magnetic resonance imaging and dissection in comparison with 3 other commonly used techniques of rejuvenating injections. RESULTS: Between the dermis and the tendons, the thickness of the fascial plane was measured from 0.3 to 2.2 mm. Because of numerous fibrous septa, the entire plane was found as a 3-dimensional sponge-like framework. Veins could be located in all levels of this framework. There was no predefined free space. The optimal place for the deposition of a filler was found to be the undersurface of the dermis. The specific technique named Scrape Skin Threading Technique and using a cannula scraping the deep side of the dermis was checked as the only technique which could give a perfect placement of product restricted to the fascial layer. CONCLUSION: The Scrape Skin Threading Technique was designed to inject safely and accurately any kind of injectable in contact with the undersurface of the dermis, which appeared anatomically as the optimal location of a filler for enhancing the outer appearance of the dorsum of hands.

Current status of surgery in dermatology.

An article titled "Current issues in dermatologic office-based surgery" was published in the JAAD in October 1999 (volume 41, issue 4, pp. 624-634). The article was developed by the Joint American Academy of Dermatology/American Society for Dermatologic Surgery Liaison Committee. A number of subjects were addressed in the article including surgical training program requirements for dermatology residents and selected advances in dermatologic surgery that had been pioneered by dermatologists. The article concluded with sections on credentialing, privileging, and accreditation of office-based surgical facilities. Much has changed since 1999, including more stringent requirements for surgical training during dermatology residency, and the establishment of 57 accredited Procedural Dermatology Fellowship Training Programs. All of these changes have been overseen and approved by the Residency Review Committee for Dermatology and the Accreditation Committee for Graduate Medical Education. The fertile academic environment of academic training programs with interaction between established dermatologic surgeons and fellows, as well as the inquisitive nature of many of our colleagues, has led to the numerous major advances in dermatologic surgery, which are described herein.

Facial Soft-Tissue Fillers: Assessing the State of the Science conference---Proceedings report.

The American Academy of Dermatology and the American Society of Plastic Surgeons, with the support of other sister societies, conducted the Facial Soft-Tissue Fillers: Assessing the State of the Science conference in December of 2009. The American Academy of Dermatology and the American Society of Plastic Surgeons established a panel of leading experts in the field of soft-tissue fillers-from researchers to clinicians-and other stakeholders for the conference to examine and discuss issues of patient safety, efficacy, and effectiveness in relation to the approved and off-label use of soft-tissue fillers, and other factors, including the training and level of experience of individuals administering fillers. This report summarizes the deliberations and key points made by the panel and presenters to the panel, and includes a summary of the panel's near-term and longer term recommendations for next steps to help guide future efforts to address the safety, efficacy, and effectiveness of facial soft-tissue fillers. This report represents the panel's assessment of the medical knowledge available on facial soft-tissue fillers at the time of the conference.

Facial Soft-Tissue Fillers conference: Assessing the State of the Science.

The American Academy of Dermatology and the American Society of Plastic Surgeons, with the support of other sister societies, conducted the Facial Soft-Tissue Fillers: Assessing the State of the Science conference in December of 2009. The American Academy of Dermatology and the American Society of Plastic Surgeons established a panel of leading experts in the field of soft-tissue fillers-from researchers to clinicians-and other stakeholders for the conference to examine and discuss issues of patient safety, efficacy, and effectiveness in relation to the approved and off-label use of soft-tissue fillers, and other factors, including the training and level of experience of individuals administering fillers. This report represents the systematic literature review that examines comprehensively the available evidence and gaps in the evidence related to soft-tissue fillers, to inform and support the work of the state-of-the-science conference panel. This evidence-based medicine review will serve as the foundation for future evidence-based medicine reports in this growing field.

Facial soft-tissue fillers conference: assessing the state of the science.

SUMMARY: : The American Society of Plastic Surgeons and the American Academy of Dermatology, with the support of other sister societies, conducted the Facial Soft-Tissue Fillers: Assessing the State of the Science conference in December of 2009. The American Society of Plastic Surgeons and the American Academy of Dermatology established a panel of leading experts in the field of soft-tissue fillers-from researchers to clinicians-and other stakeholders for the conference to examine and discuss issues of patient safety, efficacy, and effectiveness in relation to the approved and off-label use of soft-tissue fillers, and other factors, including the training and level of experience of individuals administering fillers. This report represents the systematic literature review that examines comprehensively the available evidence and gaps in the evidence related to soft-tissue fillers, to inform and support the work of the state-of-the-science conference panel. This evidence-based medicine review will serve as the foundation for future evidence-based medicine reports in this growing field.

Soft-tissue augmentation with hyaluronic acid and calcium hydroxyl apatite fillers.

Soft-tissue augmentation with hyaluronic acid and calcium hydroxyl apatite are among the most widely used minimally invasive cosmetic treatments for the correction of contour deficiencies and wrinkles of the face without the risk, recovery time, and expense of a major surgery. Training and experience in the art and science of fillers is essential for the successful creation of a more youthful and natural appearance. An understanding of the different products, the injection techniques, the indications, and the potential complications of each filler are paramount to success.

Calcium hydroxylapatite (Radiesse) for treatment of nasolabial folds: long-term safety and efficacy results.

BACKGROUND: Calcium hydroxylapatite (CaHA, Radiesse) is approved by the Food and Drug Administration for treatment of moderate to severe wrinkles and folds, including nasolabial folds (NLF). A pivotal NLF split-face study previously compared the performance of Radiesse to human-based collagen at six months and safety of Radiesse through one year. OBJECTIVE: The authors assess the long-term safety and effectiveness of Radiesse for the treatment of NLF. Postapproval long-term results now extend to more than three years and are presented here. METHODS: This study reports an extension phase of a previously reported one-year premarket study of 117 patients comparing Radiesse to collagen. During the initial study, patients were treated to optimal correction and then followed for 12 months; they were offered retreatment with Radiesse between six and 12 months in both folds to balance asymmetry. Of the 117 original split-face study subjects with moderate to severe NLF, 102 were enrolled in this extended follow-up. During this extension study, treating physicians used the Global Aesthetic Improvement Scale (GAIS) and clinical examination to evaluate subjects at intervals up to 39 months after the last injection of Radiesse. RESULTS: Forty percent of the folds evaluated at least 30 months after the last Radiesse treatment were graded as "improved" or better on the GAIS. Expectedly, the reported improvement was substantially less at this later time point than had been seen at earlier points in the premarket study, indicating some moderate, sustained improvement in some patients. There were no long-term or delayed-onset adverse events in these 102 patients followed for three years, including no reports of nodules, granulomata, or infections, such as have been reported with certain other dermal fillers. CONCLUSIONS: These results demonstrate the long-term safety and effectiveness of Radiesse. Three years after Radiesse injection, no delayed-onset or long-term adverse events were reported. In addition, many patients showed some long-term cosmetic improvement. The durability and safety of Radiesse compare favorably with other injectable fillers.

Controlled, randomized study of pain levels in subjects treated with calcium hydroxylapatite premixed with lidocaine for correction of nasolabial folds.

BACKGROUND: Calcium hydroxylapatite (CaHA) has been administered after nerve block injection of anesthetic agents. OBJECTIVES: This prospective, randomized, split-face, single-blind study (50 subjects) assessed the pain reduction, safety, and effectiveness of premixing CaHA with 2% lidocaine for the treatment of nasolabial folds (NLFs). METHODS AND MATERIALS: Subjects were randomized to receive treatment with CaHA alone in one NLF (control) and with CaHA premixed with lidocaine in the other NLF (treatment). Subjects completed pain assessments using a validated visual analog scale at specified time points immediately after injection, 1 hour after injection, and 1 month later. Subjects also indicated relative pain experience and preference assessments. Investigators completed aesthetic assessments at 2 weeks and 1 month. Subjects and investigators recorded adverse events. RESULTS: Subjects reported statistically significantly less pain in the treatment fold than in the control fold and expressed unanimous preference for the treatment injection over the control. Aesthetic results were essentially equivalent for both treatments. CONCLUSION: Investigators concluded that CaHA premixed with lidocaine results in significant pain reduction during dermal filler injection while maintaining the aesthetic improvement of CaHA without lidocaine and demonstrating comparable local transient adverse events for treatment and control. BioForm Medical (San Mateo, CA) provided the soft tissue filler, lidocaine, and other necessary supplies used in this study. All authors are members of the Bioform Medical Education Faculty.

Calcium hydroxylapatite (Radiesse): safety, techniques and pain reduction.

Although the cosmetic applications of injectable calcium hydroxylapatite (CaHA) commenced in the first years of the 21st century, only recently has the clinical use of this filler been optimized. This update will review safety, techniques, pain reduction by mixing with lidocaine and the use of CaHA in ethnic skin.

An investigation of changes in physical properties of injectable calcium hydroxylapatite in a carrier gel when mixed with lidocaine and with lidocaine/epinephrine.

INTRODUCTION: As physicians incorporate calcium hydroxylapatite (CaHA) into their aesthetic treatment regimens, the question has arisen of whether the addition of anesthetic agents to prefilled CaHA syringes might provide sufficient anesthetic prophylaxis to warrant reduction in conventional anesthetic pretreatment procedures. STUDY DESIGN: Investigators sought to determine changes in the physical properties of CaHA induced by the addition of lidocaine and lidocaine with epinephrine into the prefilled CaHA syringe. The CaHA and gel carrier (CHM) were mixed with varying amounts of lidocaine and lidocaine with epinephrine to measure the number of passes back and forth for optimal homogeneity of lidocaine and CaHA in syringes, changes in viscosity, extrusion force, needle jam rates, elasticity, and pH. RESULTS: Ten mixing passes appeared sufficient for homogeneity. Viscosities and extrusion forces of CHM/lidocaine blends decrease with increasing amount of lidocaine. Needle jams do not increase. The pH and elasticity of the CHM/lidocaine blend are essentially equivalent to those of CHM alone. Epinephrine added to lidocaine did not alter the results enough to reach statistical significance. CONCLUSIONS: Addition of lidocaine to original CHM can be safely added without harmful changes in physical properties of the original soft tissue filler. Further studies are required to explore whether the addition of lidocaine to CHM alters patient discomfort, durability, and efficacy.

Soft tissue augmentation: nonsurgical approaches to treatment of the mid and lower facial regions.

Fillers are playing an increasing role in dermatology practice, complementing the use of laser and other procedures used in skin rejuvenation. Prior to the injection of any filler, the patient should be counseled about what to expect in terms of any discomfort that may occur during or after injection, possible side effects, the results that he or she can expect, and the likely durability of correction. Knowing how and when to use dermal fillers throughout the face can help clinicians confidently educate patients regarding the full range of rejuvenation procedures that are available.

A randomized, bilateral, prospective comparison of calcium hydroxylapatite microspheres versus human-based collagen for the correction of nasolabial folds.

BACKGROUND: Current soft tissue fillers are a compromise between ease of use, duration of correction, reactivity, and cost. A product utilizing calcium hydroxylapatite (CaHA) is currently being used as a soft tissue filler. OBJECTIVE: The objective was to compare the efficacy and safety of CaHA microspheres versus human-based collagen for the correction of nasolabial folds. MATERIALS AND METHODS: Four centers enrolled 117 subjects with moderate to deep nasolabial folds. Subjects received CaHA on one side of the face and human collagen on the other. Up to two touch-ups were allowed. A blinded panel of experts evaluated subject photographs from initial and follow-up visits. RESULTS: Seventy-nine percent of subjects had superior improvement on the CaHA side through 6 months (p<.0001). For optimal correction, significantly less volume and fewer injections were needed for CaHA than for collagen (p<.0001). Adverse event rates were comparable, with some increase in bruising and edema for CaHA-treated sides. Adverse event duration was similar for both groups and generally resolved within 14 to 21 days. CONCLUSION: This CaHA-based product gives significantly longer-lasting correction of nasolabial folds compared to human collagen. Less total material and fewer injections are required. The adverse event profile of the product is similar to the collagen-based product.

Five-year safety and efficacy of a novel polymethylmethacrylate aesthetic soft tissue filler for the correction of nasolabial folds.

BACKGROUND: A novel soft tissue filler composed of polymethylmethacrylate (PMMA) microspheres suspended in a collagen gel matrix containing 0.3% lidocaine (ArteFill, Artes Medical, Inc.) was recently approved by the Food and Drug Administration for the correction of nasolabial folds. A randomized, multicenter, controlled pivotal trial performed in the United States established the safety and efficacy of this medical device throughout a 12-month study period. OBJECTIVE: The objective was to substantiate the long-term 5-year safety and efficacy of this novel soft tissue PMMA filler. METHODS AND MATERIALS: Attempts were made to contact all subjects treated with the PMMA filler that were enrolled in the original pivotal study. Safety was assessed by standard adverse event reporting methods. Efficacy was determined using a validated six-point facial fold assessment photometric grading scale using blinded observers' assessment of standardized photographs. RESULTS: Subjects (n=119) demonstrated significant improvement in nasolabial folds comparing baseline (before any treatment) to 5 years after their last treatment (p<.001). Notably, subjects also demonstrated continued improvement between 6 months after their last treatment and Year 5 (p=.002). No serious unanticipated device-related adverse events were reported. CONCLUSION: This PMMA filler is the first soft tissue filler to demonstrate continued improvement and persistence of correction over a 5-year period posttreatment.

Calcium hydroxylapatite (Radiesse) for correction of the mid- and lower face: consensus recommendations.

Restoring volume in the middle and lower portions of the face is becoming an indispensable component of modern facial rejuvenation. Radiesse (BioForm Medical, San Mateo, Calif.) is an injectable filler material composed of synthetic calcium hydroxylapatite microspheres (30 percent) suspended in an aqueous carrier gel (70 percent). At present, Radiesse is indicated in the United States for correction of moderate to deep nasolabial folds and for correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Its off-label use in other facial aesthetic indications is widely reported in the literature. The ability of Radiesse to provide immediate and durable effects has fueled interest in its use for expanded aesthetic applications, particularly in the middle and lower face. The authors' consensus panel, consisting of a cross-section of experts in plastic surgery, facial plastic surgery, and dermatology, was convened to review the scientific literature and compare clinical experiences regarding the use of calcium hydroxylapatite. This report describes the characteristic effects of aging in the middle and lower face and reviews the composition of calcium hydroxylapatite, its safety and durability, and its appropriate use in a variety of facial applications, including nasolabial folds, correction of human immunodeficiency virus-associated lipoatrophy, augmentation of the malar, submalar, and zygomatic regions, and correction of oral commissure defects, marionette lines, and prejowl sulcus. Recommendations for Radiesse use in each area, including anesthesia, and injection techniques are provided. Measures for enhancing patient comfort, anticipating and minimizing potential complications, and optimizing aesthetic results are also discussed.