Background and ObjectiveMagnetic muscle stimulation (MMS) is a relatively new energy‐based technology that provides a non‐invasive option for body contouring through stimulation and toning of underlying skeletal muscles. This study was conducted to examine the safety, efficacy, and body satisfaction scores of MMS using a CoolToneTM prototype for the aesthetic improvement of abdominal and buttock contour.Study Design/Materials and MethodsThis was a prospective, non‐comparative, non‐randomized, 12‐week, multicenter study. Male and female participants aged 22‐65 years received 4 MMS treatment sessions to the abdomen and/or buttocks. Body Satisfaction Questionnaire (BSQ) scores for abdomen and/or buttocks were assessed at baseline, immediately post final treatment, at 4 weeks (primary endpoint), and 12 weeks post final treatment. Subject‐rated Global Aesthetic Improvement Scale (SGAIS) was assessed at 4 weeks post final treatment (secondary endpoint), and 12 weeks post final treatment. Additional efficacy assessment included abdominal circumference obtained by 3D imaging at baseline, immediately post final treatment, and at 4 and 12 weeks post final treatment. A Subject Experience Questionnaire (SEQ) was used to assess treatment satisfaction and perspectives at 4 weeks and 12 weeks post final treatment. Adverse events (AEs) were monitored throughout the study.ResultsA total of 110 participants were recruited, who were 75% female, 80% Caucasian (mostly non‐Hispanic), average age of 39.5 years (range 22–59) with an average body mass index (BMI) of 23.3 kg/m2 (range 18–29.9). At the 4‐week post final treatment visit, the average BSQ score for participants receiving abdominal treatment (n = 93) was significantly improved with a 5.1 average increase in total score from baseline (possible score range 10–50) and by a 5.5 average increase from baseline for participants receiving buttocks treatment (n = 32) (p < 0.05). At 4 weeks post final treatment, the proportion of participants with SGAIS scores >“Improved” was 68.1% for participants receiving treatment of the abdomen (n = 94), and 81.8% for those receiving buttocks treatment (n = 33). The mean total decrease from baseline in waist circumference was significant at all time points. At the 12‐week post final treatment visit, SEQ data revealed that a majority of participants were “Satisfied” or “Very Satisfied” with overall treatment results and “Agreed” or “Strongly Agreed” that they were motivated to maintain results either by working out or by additional treatment. A total of 6 AEs related to the device and/or treatment were reported, which resolved spontaneously during the study.ConclusionTreatment of the abdomen and/or buttocks with MMS was well‐tolerated and demonstrated significant improvement in aesthetic appearance through the 12‐week post final treatment study duration. As a stand‐alone treatment, MMS expands the range of options for individualized treatment planning for patients seeking abdominal and/or gluteal muscle toning. © 2020 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals, Inc.
ObjectiveCryolipolysis is a safe and effective non‐surgical procedure for reducing subcutaneous fat. It spares adjacent structures, is associated with few adverse events, and is well‐tolerated by patients. Previous studies involving one or two simultaneous treatment sites have shown no effect on serum lipid levels or liver tests. The purpose of this study was to determine whether multiple same day treatments (abdomen plus both flanks) result in changes in these blood tests, and is safe.Study DesignThirty‐five adult males and females underwent same‐day cryolipolysis (CoolSculpting System, ZELTIQ Aesthetics) of the lower abdomen and flanks for reduction of subcutaneous fat. Serum lipids and liver tests were measured prior to treatment and at 1, 4, and 12 weeks post‐treatment. Expected treatment side‐effects were assessed immediately post‐treatment and at the 12‐week follow‐up visit. Adverse events were also monitored.MethodsTreatment consisted of one cycle to the lower abdomen using a large vacuum applicator and simultaneous treatment of both flanks, one cycle each, with medium vacuum applicators .Time between the abdomen and flanks procedures was not to exceed 30 minutes.ResultsThe procedures were well‐tolerated by patients; expected treatment effects were in general mild or moderate, and resolved without intervention. There were no clinically meaningful changes from baseline to any subsequent time point in any serum lipid test. This was also true for all liver tests. There were no treatment‐related adverse events.ConclusionMultiple cycle, same day cryolipolysis treatment of the lower abdomen and both flanks is well‐tolerated and safe. It does not lead to changes in serum lipids or liver tests at any of the measured time points following the procedure. Lasers Surg. Med. 49:640–644, 2017. © 2017 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals Inc.