BACKGROUND: Cryolipolysis has shown to significantly reduce localized subcutaneous fat, including submental fat. Temperatures below -11°C have not been used to treat the submental region. OBJECTIVE: The purpose of this study was to evaluate safety and efficacy of Cryolipolysis for noninvasive reduction of submental fat using lower temperatures and reduced treatment time. METHODS: A small volume applicator was used to treat 15 subjects, using a noninvasive tissue cooling device (CoolSculpting System, ZELTIQ Aesthetics, Pleasanton, CA, USA) during 45 and 30 minutes at -12 and -15°C, respectively, to induce reduction of submental fat. Two treatments with an interval of 10 weeks were performed. Adverse events were monitored to assess safety. Treated area was evaluated using digital photography, and caliper measurements prior treatment, 10 weeks after first treatment and 12 weeks after second treatment. All patients were also evaluated before and after 12-week postlast treatment by Magnetic Resonance Imaging (MRI). RESULTS: The mean (SD) reduction measured by skin fold caliper was 33% (3.2 mm [1.7 mm]), (95% CI, 0.2297-0.4236; P=.05), and by MRI, mean (SD) reduction was 1.78 mm (1.157 mm). Independent blinded panel was able to correctly identify 60% of before and after photographs; 12 of 15 subjects (80%) were satisfied or very satisfied with the treatment. Side effects were mild and resolved completely within 10 weeks, except for one hyperpigmentation, which resolved spontaneously within 6 months after last treatment. CONCLUSION: Cryolipolysis with colder temperature and reduced treatment time continues to be effective and is safe for noninvasive reduction of the submental fat.
BACKGROUND: Cryolipolysis has shown to significantly reduce localized subcutaneous fat, including submental fat. Temperatures below -11°C have not been used to treat the submental region. OBJECTIVE: The purpose of this study was to evaluate safety and efficacy of Cryolipolysis for noninvasive reduction of submental fat using lower temperatures and reduced treatment time. METHODS: A small volume applicator was used to treat 15 subjects, using a noninvasive tissue cooling device (CoolSculpting System, ZELTIQ Aesthetics, Pleasanton, CA, USA) during 45 and 30 minutes at -12 and -15°C, respectively, to induce reduction of submental fat. Two treatments with an interval of 10 weeks were performed. Adverse events were monitored to assess safety. Treated area was evaluated using digital photography, and caliper measurements prior treatment, 10 weeks after first treatment and 12 weeks after second treatment. All patients were also evaluated before and after 12-week postlast treatment by Magnetic Resonance Imaging (MRI). RESULTS: The mean (SD) reduction measured by skin fold caliper was 33% (3.2 mm [1.7 mm]), (95% CI, 0.2297-0.4236; P=.05), and by MRI, mean (SD) reduction was 1.78 mm (1.157 mm). Independent blinded panel was able to correctly identify 60% of before and after photographs; 12 of 15 subjects (80%) were satisfied or very satisfied with the treatment. Side effects were mild and resolved completely within 10 weeks, except for one hyperpigmentation, which resolved spontaneously within 6 months after last treatment. CONCLUSION: Cryolipolysis with colder temperature and reduced treatment time continues to be effective and is safe for noninvasive reduction of the submental fat.