A Prospective 2-Year Extension Study to Evaluate the Safety and Effectiveness of PMMA-collagen Gel for the Correction of Mid-Facial Volume Loss.

BACKGROUND: The safety and efficacy of polymethylmethacrylate (PMMA)-collagen gel for long-lasting correction of mid-face volume deficit was established for 12 months. OBJECTIVE: To determine the long-term safety, efficacy, and durability of PMMA-collagen gel for midface volume restoration at 24 and 36 months. METHODS: This prospective, single-center, 2-year extension study enrolled 22 patients treated with PMMA-collagen gel in the initial study. The primary endpoint was a 2-point improvement from baseline at 24 and 36 months on the Midface Volume Deficit Scale (MFVDS). Secondary endpoints included improvement from baseline to 24 and 36 months on the Physician- and Subject-rated Global Aesthetic Improvement Scales (PGAIS and SGAIS, respectively). RESULTS: The primary endpoint was met in 100% of the subjects, and the improvement in MFVDS score from baseline was significant at both 24 and 36 months (P<0.0001). PGAIS scores were rated as at least improved in 100% of subjects at 24 months and in 95% at 36 months. Similarly, 91% of participants at 24 months and 95% at 36 months reported enhanced appearance as measured by SGAIS. No additional adverse events were reported over the extension study. CONCLUSION: PMMA-collagen gel is a safe, effective, and durable treatment for restoring mid-face volume. J Drugs Dermatol. 2023;21(1): doi:10.36849/JDD.6966.

Plume Effect of Fractional Radiofrequency Verus Laser Resurfacing: Considerations in the COVID-19 Pandemic.

INTRODUCTION: The COVID-19 pandemic requires us all to re-evaluate aesthetic practices to ensure optimal patient safety during elective procedures. Specifically, energy-based devices and lasers require special consideration, as they may emit plume which has been shown to contain tissue debris and aerosolized biological materials. Prior studies have shown transmission of viruses and bacteria via plume (i.e., HIV and papillomavirus). The purpose of this study was to evaluate plume characteristics of the Er:YAG resurfacing laser (Sciton; Palo Alto, CA) and compare it to the Morpheus8 fractional radiofrequency device (InMode; Lake Forest, CA). METHODS: Five patients who underwent aesthetic resurfacing and/or skin tightening of the face and neck were treated with the Er:YAG (Sciton Joule, Palo Alto, CA) and/or fractional radiofrequency (Morpheus8, Lake Forest, CA) between April 1 and May 11, 2020. Data collected included patient demographics, past medical history, treatment parameters, adverse events, particle counter data, as well as high magnification video equiptment. Patients were evaluated during treatment with a calibrated particle meter (PCE; Jupiter, FL). The particle meter was used at a consistent focal distance (6-12 inches) to sample the surrounding environment during treatment at 2.83 L/min to a counting efficiency of 50% at 0.3 µm and 100% at >0.45 µm. Recordings were obtained with and without a smoke evacuator. RESULTS: Of our cohort (n = 5), average age was 58 years old (STD ±7.2). Average Fitzpatrick type was between 2 and 3. Two patients received Er:YAG fractional resurfacing in addition to fractional radiofrequency during the same treatment session. Two patients had fractional radiofrequency only, and one patient had laser treatment with the Er:YAG only. There were no adverse events recorded. The particle counter demonstrated ambient baseline particles/second (pps) at 8 (STD ±6). During fractional radiofrequency treatment at 1-mm depth, the mean recording was 8 pps (STD ±8). At the more superficial depth of 0.5 mm, recordings showed 10 pps (STD ±6). The Er:YAG laser resurfacing laser had mean readings of 44 pps (STD ±11). When the particle sizes were broken down by size, the fractional radiofrequency device had overall smaller particle sizes with a count of 251 for 0.3 µm (STD ±147) compared with Er:YAG laser with a count of 112 for 0.3 µm (STD ±84). The fractional radiofrequency did not appear to emit particles >5 µm throughout the treatment, however, the Er:YAG laser consistently recorded majority of particles in the range of 5-10 µm. The addition of the smoke evacuator demonstrated a 50% reduction in both particles per second recorded as well as all particle sizes. CONCLUSION: Re-evaluation of the plume effect from aesthetic devices has become important during the COVID-19 pandemic. Further studies are required to characterize viability of COVID-19 viability and transmissibility in plume specimens. Based on this pilot study, we recommend that devices that generate little to no plume such as fractional radiofrequency devices be used in Phase I reopening of practice while devices that generate a visible plume such as Er:YAG laser resurfacing devices be avoided and only used with appropriate personal protective equipment in addition to a smoke evacuator in Phase IV reopening.

A 12-Month Study to Evaluate Safety and Efficacy of Polymethylmethacrylate-Collagen Gel for Correction of Midface Volume Loss Using a Blunt Cannula as Measured by 3-D Imaging.

BACKGROUND: Although polymethylmethacrylate (PMMA)-collagen gel is approved for correction of nasolabial folds, there are no reports characterizing safety and efficacy in the midface, an area where fillers are often used in clinical practice. OBJECTIVE: To determine the safety and efficacy of PMMA-collagen gel for long-term volume restoration in the midface. METHODS: In this prospective, single-center, 12-month study, 23 subjects with a pretreatment Midface Volume Deficit Scale (MFVDS) grade of 3, 4, or 5 were treated with PMMA-collagen gel. Efficacy was measured by the investigator and blinded reviewers using the MFVDS at 3, 6, and 12 months. Subject Global Aesthetic Improvement Scale (SGAIS) and physician GAIS (PGAIS) ratings were collected at 3, 6, and 12 months. RESULTS: Improvement in the MFVDS score from baseline was significant at all post-treatment time points (p < .0001). All subjects with baseline MFVDS grades of 5 (severe) or 4 (significant) had a grade of 0 (none) or 1 (minimal) at 12 months. Subject GAIS (SGAIS) and PGAIS ratings of improved or much improved were 100% at Month 3 and were maintained at 12 months (PGAIS = 100%, SGAIS = 91.3%). All adverse events were minor. CONCLUSION: Polymethylmethacrylate-collagen gel is safe and effective for long-lasting correction of midface volume deficit.

Collagenase Clostridium Histolyticum-aaes for the Treatment of Cellulite in Women: Results From Two Phase 3 Randomized, Placebo-Controlled Trials.

BACKGROUND: Fibrous septae play a role in contour alterations associated with cellulite. OBJECTIVE: To assess collagenase clostridium histolyticum-aaes (CCH) for the treatment of cellulite. MATERIALS AND METHODS: Two identically designed phase 3, double-blind, randomized studies (RELEASE-1 and RELEASE-2) were conducted. Adult women with moderate/severe cellulite (rating 3-4 on the Patient Reported Photonumeric Cellulite Severity Scale [PR-PCSS] and Clinician Reported PCSS [CR-PCSS]) on the buttocks received up to 3 treatment sessions of subcutaneous CCH 0.84 mg or placebo per treatment area. Composite response (≥2-level or ≥1-level improvement from baseline in both PR-PCSS and CR-PCSS) was determined at Day 71. RESULTS: Eight hundred forty-three women received ≥1 injection (CCH vs placebo: RELEASE-1, n = 210 vs n = 213; RELEASE-2, n = 214 vs n = 206). Greater percentages of CCH-treated women were ≥2-level composite responders versus placebo in RELEASE-1 (7.6% vs 1.9%; p = .006) and RELEASE-2 (5.6% vs 0.5%; p = .002) and ≥1-level composite responders in RELEASE-1 (37.1% vs 17.8%; p < .001) and RELEASE-2 (41.6% vs 11.2%; p < .001). Most adverse events (AEs) in the CCH group were injection site related; few CCH-treated women discontinued because of an AE (≤4.3%). CONCLUSION: Collagenase clostridium histolyticum-aaes significantly improved cellulite appearance and was generally well tolerated.

Lifting and Toning of Arms and Calves Using High-Intensity Focused Electromagnetic Field (HIFEM) Procedure Documented by Ultrasound Assessment.

OBJECTIVE: The HIFEM procedure demonstrates positive outcomes on abdomen and buttock. This multi-center study aims to investigate its effect on adipose tissue and muscle mass located in upper arms and calves. MATERIALS AND METHODS: Twenty subjects (45.10±15.19 years, 24.44±3.22 kg/m2) who underwent a HIFEM procedure (4 sessions; 20 minutes per muscle group) on arms and calves were evaluated. Overall, 7 patients were treated over biceps and triceps, 4 patients over calves, and 9 patients underwent treatment of both upper arms and calves. The changes in adipose and muscle tissue of musculus biceps brachii, triceps brachii, and gastrocnemius were evaluated by using ultrasound. The results from a 1-month, 3-month, and 6-month follow-up were compared to the baseline. Digital photographs, weight measurements, satisfaction, and comfort questionnaires were assessed at baseline and follow-ups. RESULTS: Ultrasound images revealed a significant (P<0.05) increase in the muscle mass of all studied muscles, with the most noticeable improvement in biceps brachii (+16.13% at 3 months). The fat deposits over arms and calves showed significant improvement (P<0.05), reaching -15.12% at 3 months. The results peaked at 3 months and were sustained up to 6 months with a slight but insignificant decline. Aesthetic enhancement of treated areas was documented while patients were highly satisfied. CONCLUSIONS: The achieved outcomes showed that the HIFEM procedure is effective for muscle toning and fat reduction in arms and calves. The results suggest that the use of the HIFEM procedure is not limited only to abdominal and buttock shaping but is also effective for toning of arms and calves. J Drugs Dermatol. 2021;20(7):755-759. doi:10.36849/JDD.5878.

MRI Assessment of Arm and Calf Muscle Toning With High-Intensity Focused Electromagnetic Technology: Case Study.

Arms and calves have long been a subject of interest in aesthetic medicine. Current surgical and non-invasive procedures focus on sagging skin and fat deposits without targeting the muscles. The aim of this study is to investigate the feasibility of high-intensity focused electromagnetic (HIFEM) technology for arm and calf toning through simultaneous fat reduction and muscle strengthening. In this case study, two subjects received four 20-minute HIFEM treatments of biceps, triceps, and calves, with the outcomes assessed by MRI. The analysis of MRI images showed an average increase in all three muscle groups, biceps muscle mass 17.1%, triceps muscle mass 10.2%, and gastrocnemius muscle mass increased by 14.6%. In addition, the arm fat thickness was decreased by 12.8% on average and the calf fat thickness decreased by 9.9%. The results suggest that HIFEM technology is a feasible modality for both arm and calf toning. However, it will be necessary to continue to validate this outcome in a larger sample size study. J Drugs Dermatol. 2020;19(5): doi:10.36849/JDD.2020.4546.

Effects of Tazarotene 0.045% Lotion on Quality of Life in Patients With Moderate-to-Severe Acne.

BACKGROUND: In two phase 3 trials (NCT03168334, NCT03168321), participants with moderate-to-severe acne had significant symptom improvements after 12 weeks of treatment with tazarotene 0.045% lotion. Given the negative psychosocial effects of acne on patients, data from these studies were analyzed to evaluate quality of life in various subgroups. METHODS: Mean changes from baseline to week 12 in Acne-Specific Quality of Life (Acne-QoL) domain and item scores were analyzed in the pooled intent-to-treat (ITT) population and in participants who were categorized as follows: Evaluator's Global Severity Score (EGSS) score=3 (“moderate”) or score=4 (“severe”) at baseline; Acne-QoL total score ≥60 (better quality of life) or <60 (worse quality of life), based on the median score at baseline. Exploratory analyses based on sex and race were also performed. RESULTS: In the pooled ITT population (N=1614), Acne-QoL improvements were greater with tazarotene 0.045% lotion versus vehicle lotion, with significant differences in the acne symptoms domain, 3 acne symptom items, 2 self-perception items, 1 role-emotional item, and 1 role-social item (all P<0.05). Acne-QoL improvements with tazarotene 0.045% lotion were comparable between the EGSS subgroups. However, participants who self-reported worse quality of life at baseline (Acne-QoL total score <60) had notably greater improvements than those with better quality of life. Female and Black participants had greater Acne-QoL improvements than male and White participants. CONCLUSIONS: Participants treated with tazarotene 0.045% lotion had significant quality-of-life improvements. Clinician-rated symptom severity appeared to have a smaller effect on Acne-QoL outcomes than participants’ own assessments of quality of life. J Drugs Dermatol. 2020;19(11): doi:10.36849/JDD.2020.5457.

Ultrasound Assessment of Subcutaneous Abdominal Fat Thickness After Treatments With a High-Intensity Focused Electromagnetic Field Device: A Multicenter Study.

BACKGROUND: High-intensity focused electromagnetic (HIFEM) technology is intended for muscle toning, firming, and strengthening. OBJECTIVE: The goal of this study is to quantify the effect of HIFEM treatments on subcutaneous fat. MATERIALS AND METHODS: A total of 33 patients participated in the study. Each subject underwent 4 treatments on the abdomen with the HIFEM device. Ultrasound images were obtained measuring the thickness of the subcutaneous fat from 4 standardized measurement points. Ultrasound images were taken before treatment and at 1-month and 3-month follow-up visits. Photographs were captured using both 2D and 3D cameras. Weight measurements were taken, as well as surveys assessing both patient comfort, satisfaction, and adverse events. RESULTS: A significant reduction in the subcutaneous fat thickness across the abdomen was observed, averaging 19.0%/4.47 ± 3.23 mm (p < .01) at 1 month after treatment and 23.3%/5.78 ± 4.07 mm 3 months after treatment. At 1 month, the most significant reduction in subcutaneous fat was measured subumbilically (26.6%/6.25 ± 4.70 mm; p < .01) and epiumbilically (21.6%/5.08 ± 3.69 mm; p < .01). No discomfort was reported, and 91% of study participants were satisfied with their result. CONCLUSION: Based on the ultrasonographic and photographic observations, the authors conclude that the application of an HIFEM field is an effective option for the noninvasive treatment of subcutaneous fat.

The Fate of Active Acne and Acne Scars Following Treatment With Fractional Radiofrequency

INTRODUCTION: Acne vulgaris (AV) is a common skin disorder that may result in long-lasting acne scars. Techniques such as delivering fractional radiofrequency (RF) energy through miniature pins or needles have been utilized to manage active acne and acne scars. Skin restoration through dermal remodeling, neo-collagenesis, neo-elastogenesis, and epidermal re-newal are typical results of such treatments. METHODS: 15 subjects suffering from acne received 3 sessions of facial treatments, 3-4 weeks apart, using a fractional RF device with 24 pins tip of 2500µm in length. The treatment's safety and efficacy were evaluated up to 6 months after the last treatment. RESULTS: Facial photos and classifications of active acne, acne scars, and overall skin appearance demonstrated improve-ments in follow-up visits compared to baseline. No significant or unexpected adverse events were detected. CONCLUSION: The current study supports the safety and efficacy of the fractional RF treatment modality for acne condition. J Drugs Dermatol. 2019;18(12):1268-1272.

Safety and Efficacy of a Noninvasive 1,060-nm Diode Laser for Fat Reduction of the Flanks.

BACKGROUND: Preliminary reports indicate a hyperthermic diode laser treatment could be a safe and effective method for noninvasive fat reduction using the 1,060-nm wavelength. This wavelength penetrates the skin to heat subcutaneous adipocytes causing cellular disruption, leaving extracellular lipids, and cellular debris to be evacuated naturally by the body. OBJECTIVE: To evaluate the safety and effectiveness of this modality for noninvasive fat reduction of the flanks. MATERIALS AND METHODS: Forty-nine subjects received single laser treatment to 1 flank. Ultrasound images were taken at baseline, follow-up at 6 and 12 weeks after treatment. High-resolution photographs were taken at baseline and 12 weeks after treatment and then evaluated by independent reviewers. Adverse events recorded at all visits. Subjects completed a satisfaction questionnaire at the conclusion of the trial. RESULTS: Ultrasound images showed statistically significant (p < .001) average fat reduction of 2.6 ± 1.1 mm. Reviewers correctly ordered photographs 90.3% of the time. Ninety-six percentage of subjects rated that they were satisfied. Noted side effects were transient mild to moderate tenderness which subsided within 1 to 3 weeks; no serious adverse events were reported. CONCLUSION: The hyperthermic 1,060-nm diode laser treatment used in this study was safe and effective for noninvasive fat reduction of the flank.

Calcium Hydroxylapatite Dermal Filler for Treatment of Dorsal Hand Volume Loss: Results From a 12-Month, Multicenter, Randomized, Blinded Trial.

BACKGROUND: Calcium hydroxylapatite (CaHA) microspheres suspended in a carrier gel is an opaque dermal filler that has been used to provide immediate volume correction in the dorsal hands. OBJECTIVE: To assess the safety and effectiveness of CaHA for the correction of volume loss in the hands up to 12 months. MATERIALS AND METHODS: This multicenter, controlled, single-blind study (NCT01832090) included 114 subjects randomized 3:1 to CaHA treatment and untreated control groups. Effectiveness was assessed by blinded investigators using the validated Merz Hand Grading Scale (MHGS). Subject-reported improvement was assessed using the Global Aesthetic Improvement Scale. Effects of treatment on hand function were also assessed. RESULTS: A total of 75% of subjects achieved ≥1-point improvement on the MHGS (p < .0001) at 3 months (primary end point); this response was generally maintained through 12 months. Proportions of subjects reporting improvement ranged from 98% (3 months) to 86% (12 months). There were no clinically significant differences between control and CaHA-treated subjects in any hand function measure. Adverse events were generally expected, minor, short-lived, injection-related, and similar to those observed in previous CaHA clinical studies. CONCLUSION: Treatment with CaHA results in significant improvement in the appearance of the dorsal hand and is well tolerated.

Photobiomodulation with non-thermal lasers: Mechanisms of action and therapeutic uses in dermatology and aesthetic medicine.

BACKGROUND: Non-thermal laser therapy in dermatology, is a growing field in medical technology by which therapeutic effects are achieved by exposing tissues to specific wavelengths of light. OBJECTIVES: The purpose of this review was to gain a better understanding of the science behind non-thermal laser and the evidence supporting its use in dermatology. METHODS: A group of dermatologists and surgeons recently convened to review the evidence supporting the use of non-thermal laser for body sculpting, improving the appearance of cellulite, and treating onychomycosis. RESULTS: The use of non-thermal laser for body sculpting is supported by three randomized, double-blind, sham-controlled studies (N = 161), one prospective open-label study (N = 54), and two retrospective studies (N = 775). Non-thermal laser application for improving the appearance of cellulite is supported by one randomized, double-blind, sham-controlled study (N = 38). The use of non-thermal laser for the treatment of onychomycosis is supported by an analysis of three non-randomized, open-label studies demonstrating clinical improvement of nails (N = 292). CONCLUSIONS: Non-thermal laser is steadily moving into mainstream medical practice, such as dermatology. Although present studies have demonstrated the safety and efficacy of non-thermal laser for body sculpting, cellulite reduction and onychomycosis treatment, studies demonstrating the efficacy of non-thermal laser as a stand-alone procedure are still inadequate.

A Multicenter Study for Cellulite Treatment Using a 1440-nm Nd:YAG Wavelength Laser with Side-Firing Fiber.

BACKGROUND: Treatment of cellulite using a 1440-nm YAG wavelength laser with side-firing fiber has proven safe and effective, lasting at least 6 months. OBJECTIVES: The authors evaluate the safety and efficacy of a single, subdermal procedure to treat the underlying structure of cellulite for at least 1 year. METHODS: Fifty-seven patients underwent a 3-step cellulite treatment with a 1440-nm Nd:YAG laser with a side-firing fiber and temperature-sensing cannula. Efficacy was measured by the blinded evaluators to distinguish baseline photos from those taken at 12 months posttreatment, with results on a 5-point, 2-category ordinal photonumeric scale when comparing baseline photos to 12 months posttreatment. Subject and physician satisfaction was assessed based on completion of a satisfaction survey. Adverse events (AE) were recorded throughout the study. Twelve month data were analyzed and compared to 6 month data. RESULTS: Evaluators chose baseline photographs 97% on average from 6 (-1, +2) months and 91% from the 12 (-3, +2) months posttreatment photographs. At 6 (-1, +2) months, the average improvement score was 1.7 for dimples and 1.1 for contour irregularities. At 12 (-3, +2) months, the average improvement score was 1.4 for dimples and 1.0 for contour irregularities. The average satisfaction score for the physician was 5.6 and the patient was 5.3 on a 6-point scale. CONCLUSIONS: A single, 3-step, minimally invasive laser treatment using a 1440-nm Nd:YAG laser, side-firing fiber, and temperature-sensing cannula to treat the underlying structure of cellulite proved to be safe and maintained effectiveness at least 1 year post treatment. LEVEL OF EVIDENCE 2: Therapeutic.

Quantitative & qualitative evaluation of the efficacy of a 1440 nm Nd:YAG laser with novel bi-directional optical fiber in the treatment of cellulite as measured by 3-dimensional surface imaging.

BACKGROUND: Cellulite gives the skin surface an orange peel or mattress-like appearance thought to be caused by expansion of subcutaneous fat, fibrotic septae and, dermal laxity and atrophy. OBJECTIVE: To evaluate the safety and efficacy of a single cellulite treatment using an Nd:YAG 1440-nm laser delivered with a special fiber delivery system and temperature control. METHODS: Women with cellulite on their thighs and buttocks were enrolled in a prospective Institutional Review Board-approved study. Subjects were 15 healthy females of all Fitzpatrick Skin types with cellulite (grades II-III). A single treatment was performed with an average of seven 5 x 5 cm squares treated per leg. Evaluations with 2D and 3D imaging, patient and blinded evaluator scales as well as skin histology were performed at baseline, 3 and 6 months post treatment. RESULTS: In the 2D photographs, blinded evaluators were able to identify treated photographs versus baseline in 90% of cases and the number of sites with improvement in contour irregularities was 94%. With 3D imaging, the average decrease in skin depressions (dimples) was 49% at 6 months and 66% of patients showed improvement in overall skin contour at 6 months follow-up. Patient and physician satisfaction scores were high and no adverse events were reported. CONCLUSION: The Nd:YAG 1440 nm laser with a special fiber delivery system produced significant improvement in cellulite with one treatment after 6 months of follow up. There were no adverse events.

A multicenter study for a single, three-step laser treatment for cellulite using a 1440-nm Nd:YAG laser, a novel side-firing fiber, and a temperature-sensing cannula.

BACKGROUND: Historically, treatments for cellulite have not been able to address all of its physiological components and require multiple sessions. OBJECTIVE: The authors evaluate the safety and efficacy of a single, subdermal procedure to treat the underlying structure of cellulite. METHODS: Fifty-seven patients underwent a 3-step cellulite treatment with a 1440-nm Nd:YAG laser with a side-firing fiber and temperature-sensing cannula. Efficacy was measured by the ability of blinded evaluators to distinguish baseline photos from those taken at 3 and 6 months posttreatment, as well as their rating of the results on a 5-point, 2-category ordinal photonumeric scale when comparing baseline photos to those taken at 2, 3, and 6 months posttreatment. Patient and physician satisfaction was assessed based on completion of a satisfaction survey at 2, 3, and 6 months posttreatment. Adverse events (AE) were recorded throughout the study. RESULTS: At 6 months posttreatment, blinded evaluators rated at least a 1-point improvement in the appearance of cellulite in 96% of treated sites. Blinded evaluators were also able to correctly identify baseline versus posttreatment photos in 95% of cases. At least 90% of patients and physicians reported satisfaction with the results of treatment throughout 6 months. AE were mild in intensity and transient to treatment. CONCLUSIONS: A single, 3-step, minimally invasive laser treatment using a 1440-nm Nd:YAG laser, side-firing fiber, and temperature-sensing cannula to treat the underlying structure of cellulite proved to be safe and maintained effectiveness at least 6 months posttreatment. LEVEL OF EVIDENCE: 2.

Concomitant use of radiofrequency and high intensity focused electromagnetic field energies for full-body remodeling: MRI evidence-based prefatory trial.

BACKGROUND: Radiofrequency and HIFEM have been used as standalone modalities in body contouring. The novel device allows their synchronous emission simultaneously in a single applicator. OBJECTIVES: This prelusive trial aims to investigate the safety and efficacy of such treatment when used on multiple body parts on the same day for a full-body remodeling. METHODS: Three female subjects (21.0 ± 2.0 years) underwent 4 treatment sessions. The treatment was applied to the abdomen, saddlebags, inner thighs, and buttocks, during each visit, lasting 30 min for each site. The outcomes were assessed through examination of MRI images acquired at baseline and 3 months post-treatment. Fat and muscle thickness were measured at predefined locations. Weight and waist, hip, and thigh circumference records along with digital photographs were also taken. RESULTS: Fat thickness measurement showed a reduction of 17.57 ± 3.22 mm in the saddlebag region, 12.43 ± 1.93 mm in inner thighs, and 10.65 ± 1.26 mm in the abdomen. The fat in the buttock region showed negligible changes. The muscle thickness increased on average by 2.98 ± 0.60 mm for rectus abdominis and 7.42 ± 1.56 mm for gluteus maximus. The circumferential reduction was also observed on the waist (7.83 ± 2.25 cm), at the level of outer thighs (2.83 ± 1.53 cm), and inner thighs (3.58 ± 1.84 cm). Digital photographs showed noticeable improvement in the overall body appearance. The treatments were safe, and no side effects were noted. CONCLUSION: The preliminary outcomes indicate that the procedure delivering HIFEM and RF simultaneously on multiple body areas on the same day could be an effective and comfortable treatment for fat reduction on multiple body parts, thickening of underlying muscles, and overall improved aesthetic appearance.

High-Intensity Focused Electromagnetic Field With Synchronized Radiofrequency Achieves Superior Gluteal Muscle Contouring Than High-Intensity Focused Electromagnetic Field Procedure Alone.

Background: The high-intensity focused electromagnetic field (HIFEM) procedure is an effective method for noninvasive toning and shaping of buttocks. Objectives: To investigate and compare the efficacy of simultaneous application of HIFEM procedure with radiofrequency (RF) heating vs HIFEM standalone procedure on the buttocks. Methods: Sixty-seven subjects (21-67 years, BMI 16-34 kg/m2) were recruited and divided into two groups. Group A received simultaneous HIFEM + RF therapy, and group B received standalone HIFEM treatments. All participants underwent four 30-minute bilateral treatments on the buttocks. The MRI was used to evaluate the changes in muscle and fat thickness. Results: Data of 32 subjects from group A and 31 subjects from group B were reviewed at 1-month follow-up. On average, subjects from group A showed a 31.3% higher increase in muscle thickness, as shown in the MRI evaluation. The gluteal muscle thickness continued to grow and peaked at a 3-month follow-up, wherein 27 patients were evaluated in each group (n = 54). Group A showed on average +24.7% increase (gluteus maximus +8.5 ± 1.9 mm, medius +6.0 ± 1.1 mm, minimus +2.9 ± 0.8 mm), while group B exhibited only +15.9% increase in muscle thickness (gluteus maximus +5.2 ± 1.1 mm, medius +3.6 ± 1.0 mm, minimus +1.6 ± 0.4 mm). On average, group A showed a 35.6% higher growth in muscle thickness. Treatments were safe and comfortable with high satisfaction rates. No adverse event was reported throughout the study. Conclusions: Our results suggest that simultaneous use of HIFEM + RF is safe and significantly more effective for gluteal contouring than the HIFEM procedure alone.

Safety and effectiveness of nano-pulse stimulation™ technology to treat acne vulgaris of the back.

BACKGROUND AND OBJECTIVES: This feasibility study describes the effects of Nano-pulse stimulation™ (NPS™) technology using the CellFX™ System on acne vulgaris of the back with the objectives of demonstrating safety and effectiveness. The CellFX System applies nanosecond pulses of electrical energy to induce highly localized regulated cell death (RCD) in the cellular structures of the targeted zone with no thermal effect on the tissue and negligible effects on surrounding non-cellular components. STUDY DESIGN/MATERIALS AND METHODS: Seventeen subjects were enrolled at two sites with thirteen subjects completing treatment. Three 7 X 7 cm regions containing at least five bacne lesions each were identified, one region treated with the CellFX across three treatment sessions, the second region treated as a sham using microneedle tip placement without delivering energy, and the third as an untreated control. RESULTS: CellFX-treated areas showed an average reduction of acne lesions of 82% by 90 days post-last procedure. Acne improvement was observed in 100% of CellFX-treated regions compared to 39% improvement in Sham regions and 31% improvement in the control regions. The most common skin effects were erythema and hyperpigmentation observed in 23% and 92% of the subjects, respectively, at the last timepoint. No serious adverse events were reported. CONCLUSIONS: CellFX is a safe and effective procedure for clearing back acne.

Radiofrequency Heating and High-Intensity Focused Electromagnetic Treatment Delivered Simultaneously: The First Sham-Controlled Randomized Trial.

BACKGROUND: Radiofrequency-based and high-intensity focused electromagnetic (HIFEM)-based devices have proved effective and safe for abdominal body shaping. Radiofrequency is known to reduce adipose tissue, whereas HIFEM treatment is effective for muscle definition. The authors investigated the efficacy of a novel device delivering synchronized radiofrequency and HIFEM treatment simultaneously for abdominal toning and fat reduction. METHODS: Seventy-two patients were enrolled and randomly divided into active (n = 48; age, 45.5 ± 13.0 years) and sham groups (n = 24; age, 44.6 ± 12.3 years). Both groups received three treatments on the abdomen once a week. The intensity in the active group was set to maximum tolerable level; in the sham group, the intensities were set to 5 percent. Ultrasound images were taken before treatment and at 1, 3, and 6 months after treatment to examine changes in subcutaneous fat and rectus abdominis muscle thickness. Digital photographs were taken, and satisfaction and therapy comfort were assessed. RESULTS: Ultrasound images of the active group at 1 month showed significant (p < 0.05) reduction in adipose tissue thickness by 20.5 percent (4.8 ± 2.6 mm), whereas rectus abdominis muscle thickness increased by 21.5 percent (2.0 ± 0.8 mm). Results at 3 months improved to 28.3 percent (7.6 ± 3.7 mm) and 24.2 percent (2.3 ± 0.9 mm), respectively. Improvements were maintained at 6 months after treatment in the active group, whereas the sham group showed no significant changes. Treatments were found to be comfortable. The active group showed higher satisfaction with outcomes. CONCLUSION: Active treatment utilizing simultaneous application of radiofrequency and HIFEM therapy resulted in a significant increase in rectus abdominis thickness and subcutaneous fat reduction, exceeding previously published results for separate HIFEM and radiofrequency treatments. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.