Safety and Efficacy of a Non-Invasive 1060 nm Diode Laser for Fat Reduction of the Abdomen openaccess articles

January 2018 | Volume 17 | Issue 1 | Original Article | 106 | Copyright © 2018

Lawrence S. Bass MD FACSa and Sean T. Doherty MD FACSb

aDepartment of Plastic Surgery, Manhattan Eye, Ear & Throat Hospital, Hofstra Northwell School of Medicine, New York, NY bDivision of Plastic Surgery, Department of Surgery, Emerson Hospital, Concord, MA

   

Table3Table4Table5

RESULTS

The two study centers enrolled 35 subjects (18 at Site 1 and 17 at Site 2). The majority of subjects treated were Caucasian (83%). Fitzpatrick skin types II-III were 77% and type IV-VI were 23% of subjects with no Fitzpatrick I subjects enrolled. 2 (6%) males and 33 (94%) females were treated with an average age of 47.6 +/-9.4 years (range, 23-61) and average baseline BMI of 25.5+/-2.6 (Table 2). Pre-treatment evaluations for enrolled subject recorded average weight at 149.1 (+/- 21.8 pounds, with BMI ranging from 22 to 31, and fat thickness layer in the proposed treated area ranged from 0.61cm to 2.95cm.Of the 35 subjects, none were discontinued due to an adverse event. 34 subjects completed the study with one lost to follow up. Enrollment data is included for all 35 subjects (Table 3).The efficacy analysis included 34 subjects based on the availability of complete 12-week photographs and ultrasound images. One additional subject was excluded due to a mismatch in the anatomic site of the ultrasound images from baseline and 12 weeks.Subjects’ weights varied modestly over the course of the study. At 6 weeks, the average change in weight was 1.4+/- 2.5 lbs., diminishing to only 0.1+2.7 lbs. at 12 weeks. The greatest weight changes were little more than 5 lbs. either up or down (Table 4). At the 6-week follow-up visit, average weight was 150.5 (+/- 22.3) and at 12 weeks 149.2 (+/-21.6) pounds for an average weight change of 0.1 pounds.Blinded evaluators correctly identified pre- and post-photographs on average 95% of the time as a group (88%, 97% and 100%, individually).Figures 2-4 illustrate three representative subjects who uniformly show a flattening of abdominal contour in the treated areas regardless of weight gain or loss.Ultrasound images showed a reduction in fat layer thickness from baseline of 1.5+/-1.23 mm at 6 weeks and 2.65+/- 1.41 mm at 12 weeks. The reductions at both 6 and 12 weeks were statistically significant compared to baseline based on a paired t-test (P less than 0.001; Table 5).At 12 weeks, 91% (31/34) of subjects were satisfied (slightly satisfied, satisfied, or extremely satisfied) with 85% being satisfied or extremely satisfied (Table 6).Adverse EventsThere were no deaths, serious adverse events (SAE’s), or unanticipated device-related events reported in this study. All the adverse events were typical laser treatment reactions and were self-limited without treatment (see Table 76). Discomfort during treatment was graded at 3.7+1.3 (n=35). This was similar between the two study centers, 3.7±1.4 (n=18) and 3.8±1.2 (n=17). Post-treatment tenderness was the most common adverse event. 74% of adverse events were reported as mild,

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