High-Intensity, High-Frequency, Parallel Ultrasound Beams for Cellulite of the Buttocks and Thighs.

BACKGROUND: Ultrasound energy can successfully treat fine lines and wrinkles, as well as lift the eyebrow and submentum. Ultrasound waves of high intensity induce thermal injury in the dermis with subsequent tissue remodeling. OBJECTIVE: To examine the utility of a novel ultrasound device that utilizes high-intensity, high-frequency, parallel ultrasound beams to improve the clinical appearance of cellulite on the thighs and buttocks. MATERIALS AND METHODS: A prospective, multicenter, clinical study investigated this novel ultrasound device using 2 treatments. RESULTS: Sixty-five subjects completed both treatments. The mean age was 46 years, and 100% were women. Fitzpatrick skin types I to VI were represented. Assessments compared 3-month follow-up with baseline. Two blinded reviewers agreed in identifying pretreatment and post-treatment photographs for 89.2%. For Cellulite Severity Scale rating, there was significant improvement of 1.61 units (p < .001). For cellulite Global Aesthetic Improvement Scale (GAIS), 89.2% had improvement, with a mean of 0.87 units (p < .001). For Laxity Scale rating, there was significant improvement of 0.70 units (p < .001). For skin laxity GAIS, 89.2% had improvement, with a mean of 0.76 units (p < .001). No device-related adverse events occurred. CONCLUSION: A novel ultrasound device that utilizes high-intensity, high-frequency, parallel ultrasound beams can safely and effectively improve the clinical appearance of cellulite on the thighs and buttocks.

A Novel Approach to Shaping the Lateral Abdomen: Simultaneous Application of High-Intensity Focused Electromagnetic (HIFEM) Therapy and Synchronized Radiofrequency at the Flanks: A Multicenter MRI Study.

BACKGROUND: An accumulation of adipose tissue on the lateral abdomen (flanks) coupled with muscle deconditioning negatively affects core stability, muscular balance, and the intrinsic strength essential for maintaining optimal body mechanics and posture. This lateral fat accumulation and diminution of muscle result in an unfavorable abdominal profile and present challenges in finding appropriately fitting attire. OBJECTIVES: The aim of this study was to explore the effectiveness and safety of the simultaneous application of high-intensity focused electromagnetic (HIFEM) therapy and synchronized radiofrequency for sculpting the lateral abdomen. METHODS: All patients were scheduled to undergo four 30-minute treatments at approximately weekly intervals and then subsequent follow-up visits at 1 month and 3 months after the last treatment. The primary evaluation assessed changes in the oblique muscles, adipose tissue thickness, and cross-sectional area (CSA) by MRI performed at baseline and follow-ups. The secondary outcomes included digital photographs of the treated areas, a Subject Satisfaction Questionnaire, and a Therapy Comfort Questionnaire. Adverse events and side effects were monitored throughout the study duration. RESULTS: The muscle tissue showed a substantial increase in thickness (+27.2%) and CSA (+29.0%). The adipose tissue measurements showed a decrease of -30.5% in CSA and -28.8% in thickness. As secondary outcomes, 81.8% of patients reported feeling more toned, and 84.9% of patients found the treatment comfortable and reported less than mild pain. CONCLUSIONS: Based on the evaluation, the study suggests that the simultaneous application of HIFEM and synchronized radiofrequency is safe and effective for reducing adipose tissue and strengthening muscle in the area of the lateral abdomen.

Clinical evaluation of the safety and efficacy of a 1060 nm diode laser for non-invasive fat reduction of the flanks.

BACKGROUND: Laser hyperthermia-induced lipolysis is a non-invasive method of localized fat treatment. Non-invasive approaches could be an option for a growing number of patients who are risk-averse and are seeking out non-invasive alternatives to surgical procedures such as liposuction. This study evaluated the safety and efficacy of a 1060 nm diode laser for the non-invasive fat reduction of the flanks. METHODS: A total of 30 subjects were enrolled in this prospective, single center study. Subjects received one 25-min treatment with a 1060 nm diode laser to both flanks. Follow-up visits were conducted at 6 and 12 weeks after the last treatment. Ultrasound adipose thickness, body weight, and circumference measurements were taken at baseline and at the 6- and 12-week follow-up visits. Subject satisfaction was assessed using a self-assessment of fat reduction, pain, and tolerability scales, and a subject satisfaction questionnaire. Safety was assessed via the presence or absence of any adverse events. RESULTS: The average age of subjects was 47.3 years. A total of 27 subjects completed the treatment and returned for both follow-up visits. An adipose reduction of 7.57 ± 1.15% at 6 weeks post-treatment (p < 0.0001) was measured using ultrasound. High subject satisfaction was seen, with 74% of subjects reporting being either "satisfied" or "very satisfied" with their results on a 5-point Likert Scale. Eighty-two percent of subjects stated they would recommend the treatment to their friends. All subjects had either mild or moderate pain, with 52% of subjects rating their pain as "mild" (1-3), while 48% rated their pain as moderate (4-7) on the Wong-Baker Scale. CONCLUSIONS: A single treatment with a 1060 nm diode laser was both safe and effective in reducing unwanted fat in the flanks without any unanticipated adverse events. Subjects described their treatment pain as mild or moderate and were highly satisfied with their treatment outcomes.

A Prospective, Open-Label Study to Evaluate Functional Changes Following Electromagnetic Muscle Stimulation of Abdominal Muscle.

Background: Electromagnetic muscle stimulation (EMMS) is an effective, well-tolerated noninvasive body contouring treatment for strengthening, toning, and firming the abdomen. Objectives: In this study, functional changes following abdominal EMMS treatment wereevaluated. Methods: In this prospective, open-label study, adults received 8 abdominal EMMS treatments (2 treatments on nonconsecutive days/week over 4 weeks). Follow-ups occurred 1 month (primary endpoint), 2, and 3 months postfinal treatment. Effectiveness endpoints included improvements from baseline on Body Satisfaction Questionnaire (BSQ; primary endpoint), core strength (timed plank test), abdominal endurance (curl-up test), and Subject Experience Questionnaire (SEQ). Safety was evaluated throughout. Results: Sixteen participants (68.8% female) were enrolled, with a mean age of 39.3 years and a mean BMI of 24.4 kg/m2; 14 participants completed the study per protocol. Mean BSQ scores were significantly improved from baseline (27.9) to the 1-month follow-up (36.6; P < .05). Core strength and abdominal endurance were significantly greater at the 1-, 2-, and 3-month posttreatment time points than at baseline (P < .05). Frequently cited reasons for seeking EMMS treatment included a desire to feel stronger (100%; n = 14/14) and to improve athletic performance (100%; n = 14/14). SEQ responses 3 months posttreatment showed that most participants reported feeling stronger (92.9%) and motivated to receive additional EMMS treatments (100%) and work out to maintain treatment results (100%). The majority of participants (>78%) reported being "satisfied" or "very satisfied" with abdominal treatment 1 month posttreatment. One device- and/or procedure-related adverse event of menstrual cycle irregularity was reported in 1 participant and was mild in severity. Conclusions: EMMS treatment of the abdomen is associated with functional strength improvements and high patient satisfaction.

Safety and Efficacy of a Novel, Variable-Sequenced, Long-Pulsed, 532-nm and 1,064-nm Laser With Cryogen Spray Cooling for Pigmented and Vascular Lesions.

BACKGROUND: Patients frequently seek treatment for vascular and pigmented lesions. More recently, a novel, variable-sequenced, long-pulsed, 532-nm and 1,064-nm laser with cryogen spray cooling was developed to offer greater flexibility in treatments. OBJECTIVE: A prospective clinical trial evaluated the safety and efficacy of a novel, variable-sequenced, long-pulsed, 532-nm and 1,064-nm laser with cryogen spray cooling (DermaV, Lutronic, South Korea). MATERIALS AND METHODS: Subjects with vascular and/or pigmented lesions were enrolled and underwent laser treatments. RESULTS: Twenty-three subjects were enrolled with vascular lesions (39.1%), pigmented lesions (17.4%), and both (43.5%). Mean age was 53.1 years, and 91.3% were women. Fitzpatrick skin types II-IV were included. All subjects were treated with 532 nm, and 4 were also treated with 1,064 nm. According to 4 blinded physician reviewers, correct before and after photographs were selected in 94.7%, 92.1%, 84.2%, and 76.3% of cases. Overall, 86.8% were responders, meaning that at least 3 of 4 reviewers agreed. For Global Aesthetic Improvement Scale, improvement occurred in 81.6%, 81.6%, 81.6%, and 76.3% of cases. No serious adverse events occurred. Overall, 87.0% of subjects reported being very satisfied or satisfied. CONCLUSION: A novel, variable-sequenced, long-pulsed, 532-nm and 1,064-nm laser with cryogen spray cooling can safely and effectively improve vascular and pigmented lesions.

Clinical evaluation of the safety and efficacy of a 1064 nm diode laser, and vacuum assisted pulsed electromagnetic fields and multipolar radio frequency for noninvasive fat reduction of the abdomen and flanks.

BACKGROUND: Noninvasive cosmetic body contouring techniques are growing rapidly, and noninvasive lipolysis has been shown to have low pain, little downtime and produce consistent long-term results. The objective of this study was to evaluate the safety and efficacy of a 1064 nm diode laser combined with vacuum assisted PEMF and RF energies for noninvasive fat reduction of the abdomen and flanks. METHODS: Subjects received a series of three treatments 8 weeks apart, each consisting of a diode laser session, followed by vacuum assisted PEMF and RF. Before and after photographs were graded for overall fat reduction by three blinded evaluators. Ultrasound was used to measure changes in the thickness of adipose tissue. Subject satisfaction was assessed using the 5-Point Likert Subject Satisfaction Scale and a subject questionnaire at 16 and 24-week follow-up visits. Throughout each treatment, the subjects were given the Wong-Baker Faces Pain Rating Scale (WBFS) to assess discomfort and pain of the treatment. RESULTS: Thirty-nine subjects (average age 48.6 years) from four clinical sites were enrolled. Evaluators identified the correct before and after images 73.1% of the time and images were graded an average score of 1.12 (SE 0.1) correlating to more than a "slight change." Adipose tissue was reduced by 31.9% based on ultrasound measurements (p < 0.001). Subject satisfaction was high with an average satisfaction score of 7.8 ("satisfied") out of 10. The overall pain over time on average was rated "hurts little bit." Ninety percent of subjects reported either a mild, moderate, or significant improvement in their fat reduction and skin surface appearance. Almost 77% (76.7%) of subjects reported that they would recommend the treatment to a friend. There were six reports of adverse events related to the device during the study that were all transient and resolved rapidly. CONCLUSION: A significant reduction of subcutaneous adipose tissue was measured after treatment with a combination of diode laser and vacuum assisted PEMF and RF. Treatment pain was low and tolerable, and subjects had high levels of satisfaction with the results.

Noninvasive Hands-free Bipolar Radiofrequency Facial Remodeling Device for the Improvement of Skin Appearance.

BACKGROUND: Aging is a multifactorial response to genetic preprogramming nuances, sun exposure, and ultraviolet radiation. Recently, there has been a paradigm shift toward minimally invasive rejuvenation. OBJECTIVE: This prospective multicenter study aims to evaluate the efficacy and safety of a novel hands-free bipolar bulk radiofrequency (RF) device in terms of improvement in skin appearance. PATIENTS AND METHODS: This multicenter prospective study enrolled subjects aged 35 to 75 years with visible signs of aging. The primary objective was to evaluate skin appearance pretreatment and at 1, 3, and 6 months after the final treatment. Each patient received 3 total treatments to the chin and cheeks using the hands-free RF device spaced 2 weeks apart. RESULTS: In total, data from 87 patients were assessed from 6 treatment sites. The average age was 54 years (range 35-75 years). Most patients were female (97%), and Fitzpatrick skin types I to V were represented. Overall, patients found the procedures to be relatively pain-free, and both patients and investigators felt they noted some improvement in their skin appearance. Histological sections demonstrated an increase in collagen or elastic fibers within the papillary dermis. CONCLUSION: This study supports the use of this novel noninvasive hands-free bipolar facial remodeling device for the improvement of skin appearance.

Dermal Micro-coring for the Treatment of Moderate to Severe Facial Wrinkles.

Micro-coring technology (MCT) removes cores of skin without formation of scars, thereby tightening skin and reducing skin wrinkling. The purpose of this study was to evaluate the safety and efficacy of MCT with the dermal micro-coring device for the treatment of facial wrinkles. Methods: This prospective, multicenter clinical trial included fifty-one subjects who underwent MCT treatments of the mid to lower face. The primary study endpoint was change in the Lemperle Wrinkle Severity Scale. Secondary study endpoints were change in Global Aesthetic Improvement Scale (GAIS), participant satisfaction, and evaluation of treatment outcome by an independent review panel. All study endpoints were evaluated at 1, 7, 30, 60, and 150 or 180 days after treatment. Procedure bleeding, pain, and early healing profile were also captured. Results: The mean Lemperle Wrinkle Severity Scale change was 1.3 grades. Improvement in the GAIS was reported for 89.7% (87/97) of treated sites, and average improvement of GAIS was 1.5. Participants reported satisfaction with 85.6% of treatment sites. The independent review panel correctly identified 84.2% of the post-treatment photographs as post-treatment. Procedure bleeding and pain was mild with good healing responses and patient-reported average down time of 3 days. Conclusions: The results of this study demonstrate the safety and efficacy of MCT with the dermal micro-coring device for the treatment of moderate to severe facial wrinkles. MCT led to significant improvement of facial wrinkles with high patient satisfaction and fast recovery time and should be considered in patients who are seeking minimally invasive treatment for wrinkles of the face.

Global Expert Opinion on Cryolipolysis Treatment Recommendations and Considerations: A Modified Delphi Study.

Background: Cryolipolysis is an increasingly popular nonsurgical fat-reduction procedure. Published treatment guidance and adverse event (AE) management protocols are limited. Objective: A modified Delphi study aimed to establish global expert consensus on the use of CoolSculpting (Allergan Aesthetics, an AbbVie Company, Irvine, CA), a noninvasive cryolipolysis treatment system. Methods: A literature search informed survey topics for an 11-expert Delphi panel. Panelists completed an online 39-question survey. An interim panel discussion, with open-ended questions and yes/no voting, informed a second survey containing 61 statements, for which panelists rated agreement using a 5-point Likert scale. Topics included treatment outcome and responder definitions, patient evaluation and selection, treatment protocols, patient satisfaction, and AEs. Results: Panelists achieved consensus on 38 final guidelines and recommendations. They reached moderate to complete consensus on 4 statements on defining responders (ie, patients with a range of visible improvement) and 6 statements on patient factors contributing to treatment outcomes (eg, how well the applicator conforms to patient body region). Panelists defined minimum numbers of treatment cycles to achieve visible clinical outcomes for 12 body regions, with moderate to complete consensus on 31 statements. They achieved a strong to complete consensus on 7 statements about patient satisfaction (eg, importance of patient expectations, visible improvement, and before-and-after photographs). Panelists defined management strategies for AEs, with moderate to complete consensus on 15 statements. Conclusions: A modified Delphi process yielded multiple guideline recommendations for cryolipolysis, providing a needed resource for the broad range of clinicians who perform this noninvasive fat-reduction procedure.

1,550 nm Erbium-Doped and 1,927 nm Thulium Nonablative Fractional Laser System: Best Practices and Treatment Setting Recommendations.

BACKGROUND: The Fraxel Dual laser system (Solta Medical, Inc., Bothell, WA) contains a 1,550 and 1,927 nm wavelength single handpiece with different indications for each wavelength. OBJECTIVE: To discuss treatment setting recommendations and best practices for select on-label and investigational applications of the 1,550 and 1,927 nm dual laser system. MATERIALS AND METHODS: Eight board-certified dermatologists with 10 or more years of experience with the 1,550 and 1,927 nm laser system completed an online survey about their clinical experience with the system and then participated in a roundtable to share clinical perspectives and best practices for using the laser system. RESULTS: For all Fitzpatrick skin types, treatment recommendations were described for selected approved indications for the 1,550 and 1,927 nm laser system, including both lasers in combination. Treatment recommendations were also reached for investigational applications with the 1,550 nm laser and 1,927 nm laser. Best practices for using the lasers during the treatment session to achieve optimal outcomes and decrease the post-treatment recovery time were compiled. CONCLUSION: The 1,550 and 1,927 nm dual laser system is effective for a wide range of aesthetic and therapeutic applications, on and off the face and across all Fitzpatrick skin types.

Clinical Evaluation of Fractional Radiofrequency for the Treatment and Reduction of Wrinkles: A Prospective Study.

BACKGROUND: Fractional radiofrequency (FRF) technology has been shown in clinical studies to improve skin laxity, and to treat various skin conditions related to aging and alternate collagen structures such as rhytids. The objective of this clinical study was to evaluate the safety and performance of FRF (up to 124 mJ per pin) for the treatment of facial rhytids, emphasizing the upper lip and perioral areas. METHODS: Enrolled subjects received a series of 3 FRF treatments to the full face, 3 to 5 weeks apart. Immediately after treatment, the subjects were given a scale to assess pain and tolerability of the treatment. Subject satisfaction questionnaires were completed at follow-up visits at 6 and 12 weeks post final treatment. Before and after photographs were graded for change by three blinded evaluators using the Fitzpatrick Wrinkle and Elastosis Scale (FWES) and the Global Aesthetic Improvement Scale (GAIS). RESULTS: Image sets of 10 enrolled subjects (average age 62.7 years) were assessed by blinded evaluators. The overall face FWES score improved from 5.97 (SE 0.20) at baseline to 5.78 (SE 0.22) at 12-week follow-up. The GAIS improved by 0.4 points and was significant compared to baseline (P = 0.0004). Subject satisfaction was high with subjects giving an average satisfaction score of 3.2 (“satisfied”) out of 4. Pain was rated “mild to moderate” with an average of 3.9 on a 11-point Wong Baker FACES Scale. Ninety percent (90%) of subjects reported either a mild, moderate, or significant improvement to their treatment area. Eighty percent (80%) of subjects reported that they would recommend the treatment to a friend. There were no reports of adverse events or unanticipated side effects during the duration of the study. CONCLUSION: A statistically significant reduction in rhytids of the upper lip and the perioral area, was found, as evaluated by independent blinded evaluators. There were no adverse events. Treatment pain was low and tolerable, and subjects had high levels of satisfaction with the results at last follow-up. J Drugs Dermatol. 2022;21(1):43-48. doi:10.36849/JDD.6492.

Optimizing Outcomes With the 1550/1927 nm Dual Wavelength Non-Ablative Fractional Laser: Experienced User Recommendations.

BACKGROUND: Fractional laser treatment was introduced in 2004 as a non-invasive technique to treat sun-damaged and aging skin. Since then, numerous ablative and non-ablative photothermolysis technologies and devices have been introduced, increasing the options for clinicians and patients but also increasing the complexity regarding which system to use and the techniques to optimize outcomes. No two devices are the same and the user-manuals preset dosimetry does not address many clinical situations, which can create confusion for new and inexperienced users. METHODS: An online survey addressing use of a 1550 nm /1927 nm dual wavelength, non-ablative, fractional laser was sent to eight (8) US board certified dermatologists with extensive experience in the use of the device. The survey included 39 questions, addressing experience, best practices and recommendations for use. RESULTS: The survey data suggests that the device can be used to treat patients of all ages and skin types for indications including photoaging and photodamage, periorbital wrinkles, freckles, (ephelides), solar lentigines, poikiloderma, scarring due to acne or surgery. It can be used on both facial and non-facial areas, including neck, chest, hands, arms, abdomen, legs, and buttocks. Unexpected and adverse effects were rarely reported and those that did were mild and transient. CONCLUSIONS: This position paper provides practical real-world guidelines resulting from a small survey of experienced users, for new and early uses of the novel 1550 nm /1927 nm dual wavelength, non-ablative, fractional laser. J Drugs Dermatol. 2021;20(11):1150-1157. doi:10.36849/JDD.6181.

Cytrellis: A Novel Microcoring Technology for Scarless Skin Removal: Summary of Three Prospective Clinical Trials.

BACKGROUND: We introduce an innovative and novel technology that achieves scarless skin removal without the use of thermal energy. Microcoring technology (MCT) uses a modified, hollow hypodermic needle to remove skin safely and without a scar. This method is advantageous compared to other fractional devices, given that it has the same benefits as energy-based devices (removal of skin cores without a scar), with the added value of immediate closure along the relaxed skin tension lines, with significantly less thermal energy. METHODS: Three prospective clinical safety trials analyzing MCT treatment on abdominal and facial skin (short- and long-term) are described. RESULTS: MCT treatment of human skin resulted in scarless skin removal that was well tolerated by patients. Healing occurred rapidly, with limited side effects. Skin area reduction (skin tightening) and increase in skin thickness were observed long term. CONCLUSIONS: MCT treatment of human skin is safe and well tolerated. Although further studies on efficacy are required to evaluate the full potential of MCT in skin rejuvenation, early findings such as skin tightening and increase in skin thickness are encouraging.

Clinical Evaluation of the Safety and Efficacy of a 1060-nm Diode Laser for Non-Invasive Fat Reduction of the Abdomen.

BACKGROUND: Despite the proven efficacy of liposuction, there is a population of patients who prefer non-surgical alternatives. Laser hyperthermia-induced lipolysis has emerged as one non-invasive alternative to liposuction. OBJECTIVES: The authors sought to evaluate the safety and efficacy of a 1060-nm (±10 nm) diode laser for non-invasive fat reduction of the abdomen. METHODS: This single-arm, 2-center study enrolled 30 patients. Patients received a 25-minute 1060-nm diode laser treatment on their abdomen. Ultrasound adipose measurements, body weight, and circumference were taken at baseline and at 6- and 12-week follow-up visits. Blinded evaluators identified "before" and "after" photos of each patient. A patient satisfaction questionnaire was completed by each patient at study exit. RESULTS: A total 29 patients completed all treatment and follow-up visits. Ultrasound images showed an adipose reduction of 8.55% at 12 weeks post-treatment (P < 0.0001). Blinded evaluators correctly identified 67% of the pre- and post-treatment images at site 01 (Sacramento, CA) and 56% at site 02 (Dallas, TX). Satisfaction was high, with 72% of patients reporting being either "satisfied" or "very satisfied" with their results on a 5-point Likert scale. Pain was rated as mild by 62% of patients, moderate by 38%, and severe by none on the Wong-Baker Scale. CONCLUSIONS: These results indicate that a single treatment with a 1060-nm (±10 nm) diode laser, per the treatment protocol, is safe and effective in reducing unwanted fat in the abdomen as objectively measured employing ultrasound. The treatment was well-tolerated among all patients, with minimal discomfort reported and high patient satisfaction.

Aesthetic Office Disaster Preparedness and Response Plan.

The coronavirus pandemic (COVID-19) has served as a call-to-arms in preparing practices for the next disaster whether it is another infectious disease or a flood, hurricane, earthquake, a sustained power outage, or something else. A group of predominantly core aesthetic physicians discussed the various aspects of their office procedures that warrant consideration in a proactive approach to the next pandemic/disaster-related event. This guide does not set a standard of practice but contains recommendations that may avoid some of the "lessons learned" with the COVID-19 pandemic. In this paper, the board-certified core aesthetic physicians classified these recommendations into four generalized areas: Practice Management; Supplies and Inventory; Office Staffing Considerations and Protocols; and Patient Management Strategies. Proactive strategies are provided in each of these categories that, if implemented, may alleviate the processes involved with an efficient office closure and reopening process including, in the case of COVID-19, methods to reduce the risk of transmission to doctors, staff, and patients. These strategies also include being prepared for emergency-related notifications of employees and patients; the acquisition of necessary equipment and supplies such as personal protective equipment; and the maintenance and accessibility of essential data and contact information for patients, vendors, financial advisors, and other pertinent entities.J Drugs Dermatol. 2021;20(1):10-16. doi:10.36849/JDD.5803.

Feasibility Study of Electromagnetic Muscle Stimulation and Cryolipolysis for Abdominal Contouring.

BACKGROUND: In addition to reducing subcutaneous fat for body contouring, some patients are interested in toning the underlying muscle layer. OBJECTIVE: This feasibility study evaluated the safety and efficacy of electromagnetic muscle stimulation (EMMS) alone, cryolipolysis alone, and cryolipolysis with EMMS for noninvasive contouring of abdomen. METHODS: Abdomens of 50 subjects were treated in a study with 3 cohorts: EMMS alone, Cryolipolysis alone, and Cryolipolysis + EMMS in combination. Electromagnetic muscle stimulation treatments were delivered in 4 sessions over 2 weeks. Cryolipolysis treatments were delivered in one session. Combination treatments consisted of one cryolipolysis and 4 EMMS visits. Efficacy was assessed by independent physician Global Aesthetic Improvement Scale (GAIS), circumferential measurement, Subject GAIS (SGAIS), and Body Satisfaction Questionnaire (BSQ). RESULTS: Safety was demonstrated for all study cohorts with no device- or procedure-related adverse events. Independent photo review showed greatest mean GAIS score for the Cryolipolysis + EMMS cohort followed by Cryolipolysis only, then EMMS only cohort. BSQ showed greatest average score increase for Cryolipolysis + EMMS cohort followed by Cryolipolysis only cohort, then EMMS only cohort. Mean circumferential reduction measurements were greatest for Cryolipolysis + EMMS cohort followed by Cryolipolysis only, and then EMMS only cohort. The mean SGAIS improvement score was equal for the Cryolipolysis only and Cryolipolysis + EMMS cohorts, followed by the EMMS only cohort. CONCLUSION: A multimodal approach using cryolipolysis and EMMS was safe and demonstrated enhanced body contouring efficacy for this feasibility study.

Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia.

BACKGROUND: Nanosecond pulsed electric field (nsPEF) technology involves delivery of ultrashort pulses of electrical energy and is a nonthermal, drug-free technology that has demonstrated favorable effects on cellular structures of the dermis and epidermis. OBJECTIVE: Determine the tolerability and effectiveness of nsPEF treatment of sebaceous gland hyperplasia (SGH). METHODS: This study was a prospective, randomized, open-label, multisite, nonsignificant risk trial in which each subject served as their own control. After injection of local anesthetic, high-intensity, ultrashort pulses of electrical energy were used to treat 72 subjects resulting in a total of 222 treated lesions. Subjects returned for 3 to 4 follow-up evaluations with photographs. RESULTS: At the final study visit, 99.6% of treated SGH lesions were rated clear or mostly clear and 79.3% of the subjects were satisfied or mostly satisfied with the outcome. At 60 days after nsPEF treatment, 55% of the lesions were judged to have no hyperpigmentation and 31% exhibited mild post-treatment hyperpigmentation. At the last observation for all lesions, 32% of the 222 lesions were noted as having slight volume loss. CONCLUSION: Nanosecond pulsed electric field procedure is well tolerated and is very effective in the removal of SGHs. TRIAL REGISTRATION: ClinicalTrials.gov NCT03612570.

Non-Surgical Fat Reduction and Topical Modulation of Adipose Tissue Physiology

Non-surgical fat reduction procedures have gained in popularity over the past few years and remain in great demand. The process results in accumulation of breakdown products, lipid droplets, that are slowly absorbed over a period of months. This paper outlines the physiological process whereby lipid droplets are absorbed through a process of autophagy (lipophagy) involving a repackaging of these droplets to smaller sizes so that macrophages can then cope with digestion of these very large particles. Furthermore, a fat compartment is described within the dermis surrounding the tail of the hair follicle, which is attracting much attention due to its unique phenotype, function, and connection to the deeper subcutaneous fat compartment. This provides an entry route for direct signaling to the subcutaneous fat. Related to these novel concepts, peptides can be designed in liposomal delivery systems to target lipid droplet breakdown via the hair follicle entry route. This concept is elucidated in this paper. J Drugs Dermatol. 2019;18(4):375-380.

An Observational Study of the Safety and Efficacy of Tissue Stabilized-Guided Subcision.

BACKGROUND: Cellulite is a common female cosmetic concern for which there are few treatment options with long-term effectiveness data. The aim of this multisite prospective registry study was to collect observational data on the real-life clinical use of a tissue stabilized-guided subcision (TS-GS) system for long-term improvement of cellulite appearance. METHODS: Fifty-three subjects were enrolled and received a single treatment using the TS-GS system. Physicians treated the subjects according to their standard of care. Global Aesthetic Improvement Scale (GAIS) was completed by the patient and clinician assessing overall aesthetic improvement after 180 days. Treatment parameters, pain scores, quality of life data, and expected treatment effects and adverse events were also recorded throughout the study. RESULTS: The patient and physician GAIS scores at Day 180 revealed an overall improvement in 91% and 96% of patients, respectively. Quality of life and self-confidence scores also improved through 180 days. No serious adverse events were reported. Expected treatment effects were similar to those reported in the pivotal trial supporting FDA clearance. CONCLUSION: This study demonstrated significant improvement in the appearance of cellulite after a single treatment session in patients with moderate-to-severe cellulite. These results are consistent with the previously published the pivotal study data.