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.

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.

Submental fat reduction using sequential treatment approach with cryolipolysis and ATX-101.

BACKGROUND: Submental fat (SMF) detracts from facial aesthetics and negatively impacts self-image. AIMS: To evaluate safety, effectiveness, and satisfaction of cryolipolysis and ATX-101 used sequentially to reduce SMF. METHODS: A prospective, open-label, interventional, single-site study enrolling 22- to 65-year-old participants rated as Grade 4 (extreme) on the Clinician-Rated SMF Rating Scale (CR-SMFRS). Co-primary effectiveness endpoints were proportions of participants with ≥1-grade and ≥2-grade improvement on CR-SMFRS at 12 weeks post final treatment. Additional assessments included ultrasound measurement of fat thickness and Subject Self-Rating Scale (SSRS) scores at 12 weeks post final treatment. Safety was assessed throughout the study. RESULTS: Of 16 enrolled participants, 62.5% were female, mean age of 43, and mean body mass index of 31.8 kg/m2 . 100% of participants achieved ≥1-grade improvement, and 71.4% achieved ≥2-grade CR-SMFRS improvement. Mean (SD) reduction in SMF thickness was 0.2 mm (1.3), and SSRS scores ≥4 (slightly to extremely satisfied) were reported by 71.4% of participants. Adverse events (AEs) were mild and resolved by study end. No unanticipated adverse device effects or serious or unexpected AEs occurred. CONCLUSION: Sequential treatment with cryolipolysis and ATX-101 was found safe and effective for reducing extreme SMF, resulting in approximately a 2-grade improvement.