RESUMEN
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.