Cryolipolysis is a safe and effective noninvasive treatment for reducing submental fat, according to a review of several published studies.

In a review of four clinical trials and one case series, which involved a total of 101 patients, cryolipolysis was associated with a statistically significant reduction in submental fat with few adverse effects, reported Shari R. Lipner, MD , of the department of dermatology at Cornell University, New York.

In 2015, the Food and Drug Administration cleared a cryolipolysis device for use in the submental area.

The literature review was performed in May 2017 using Pubmed, EMBASE, Web of Science, and CINAHL databases, searching for the terms cryolipolysis, submental, and paradoxical adipose hyperplasia. Non-English studies were excluded.

The studies included an open-label prospective multicenter trial of 60 patients who underwent cryolipolysis for submental fat reduction once or twice at –10°C for 60 minutes, which found that in 58 evaluable patients, blinded independent reviewers correctly identified baseline photos in 91.4% of cases (P less than .0001). Ultrasound, used to evaluate 57 patients, determined the mean fat layer reduction was 2.0 mm or 20% (ranging from an increase of 2.0 mm to a reduction of –5.9 mm; P less than .0001). Side effects included erythema, edema, bruising, and numbness, which resolved by week 12. Additionally, 83% of the 60 patients were satisfied with the results.

In another study, a prospective nonrandomized study that evaluated overlapping cryolipolysis applications on different visits in 14 patients, pretreatment and post-treatment photographs were correctly identified by blinded independent reviewers 81% of the time (95% confidence interval, 65.9%-91.4%; P = .02). In addition, the mean fat layer reduction, as measured with skin-fold calipers, was 2.3 mm (95% CI, 1.9-2.7 mm; P less than .001), and 93% of the patients were satisfied with the results.

A prospective nonrandomized single-center open-label study of 15 Hispanic patients evaluated cryolipolysis applied to the submental area at two different temperatures (–12°C for 45 minutes and –15°C for 30 minutes) with treatments given 10 weeks apart. The mean reduction in submental fat, as measured by calipers, was 33%, with no significant difference between the two. Blinded physicians correctly identified pre- and post- treatment photos in 60% of cases, and 80% of the patients said they “were satisfied or very satisfied” with the results, according to Dr. Lipner’s review, published online in the Journal of Cosmetic Dermatology .

All studies reported adverse side effects, most commonly erythema, which resolved within weeks of treatment, she wrote. To date, she noted, no cases of mandibular nerve injury or paradoxical adipose hyperplasia have been reported after cryolipolysis for submental fat.

Dr. Lipner referred to early trials in humans found that cryolipolysis was safe and effective for treatment of the back, arms, and chest. Additional trials found no significant changes in lipids or liver function at 1, 4, and 12 weeks’ follow-up when patients were treated for fat in the flanks and lower abdomen.

The results of the literature review suggest that cryolipolysis is safe and effective for submental fat, Dr. Lipner wrote. Appropriate patient selection is important and “patients should be counseled on clinical improvement in the submental contour, number of sessions necessary, side effects, downtime, and cost,” she noted. Liposuction is still the gold standard for removal of large fat deposits, and although cryolipolysis can reduce submental fat, “it may also worsen the appearance on the neck by making platysmal banding or skin imperfections more obvious,” she added.

Dr. Lipner did not report any relevant disclosures. No funding source was provided.

SOURCE: J Cosmet Dermatol. 2018 Jan 17. doi: 10.1111/jocd.12495 .