Abstract

Cryolipolysis of the arms has been demonstrated to be an effective treatment for non-invasive reduction of subcutaneous fat. This study evaluated the safety and efficacy of the concurrent use of a new commercially-available small applicator in conjunction with an existing medium sized applicator for the customized treatment of arm fat. Bilateral arms of 15 eligible subjects were simultaneously treated using one or two vacuum applicators with flat contours. Either a medium or small cryolipolysis applicator with an oblong cup-shaped cooling surface was selected to treat upper arm fat. The shape of the fat bulge in each subject's arm was assessed and up to two treatment cycles (-11°C for 35 minutes each) were delivered to each arm in one session, based upon investigator discretion. Throughout the procedure and at the completion of each treatment cycle, investigators assessed the subject's level of comfort, as well as sensory and motor nerve effects. Post-treatment manual massage was performed, and clinical assessments of each treatment site were recorded. Adverse events were recorded to monitor procedural safety. Baseline and 12 weeks post-treatment photographs and ultrasound measurements were taken to assess efficacy. Subject questionnaires were administered to evaluate satisfaction. Fifteen female subjects (mean age of 51.1, mean BMI of 26.8) completed the study. Ultrasound imaging revealed statistically significant fat layer reduction of 2.5 mm (SD ± 2.4 mm, 95%CI 1.6-3.3). Subject surveys administered 12 weeks post-treatment demonstrated 87% satisfaction with the arm cryolipolysis procedure. A panel of blinded, independent physicians correctly identified 83% of the before and after photos. Clinical assessments found adverse events were mild and included erythema and mild swelling that resolved without intervention. Mild treatment area numbness was reported by 73% of subjects at the 4-week interim visit and fully resolved at the 12-week visit. This study documents the first reported customized approach for assessment and treatment of arm fat using a small or medium cup applicator with varied applicator placement. By incorporating one or two treatment cycles per arm in a single session, the issue of variable fat distribution in people's arms can be addressed. This approach was shown to be a safe and effective way to reduce unwanted arm fat with high patient satisfaction. Lasers Surg. Med. © 2018 Wiley Periodicals, Inc.

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