WAIKOLOA, HAWAII – Patient interest is soaring in fat cell reduction via cryolipolysis using the noninvasive CoolSculpting technology, Dr. Suzanne L. Kilmer said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
She was one of the developers of the “treatment to transformation” (T2T) approach to CoolSculpting, in which larger areas of fat deposits are safely treated per session than in the earliest days of the therapy’s availability.
“Treatment to transformation has been a home run. Our use of this approach has increased greatly in our practice because a lot of people don’t want to do liposuction, which has more risk and downtime. We’ve purchased a second device to accommodate patients and treat two areas at once, said Dr. Kilmer, director of the Laser and Skin Surgery Center of Northern California in Sacramento.
She was lead author of the pivotal trial which led to Food and Drug Administration clearance of Zeltiq Aesthetics’ CoolSculpting for treatment of submental fat. That’s the fifth body area for which FDA clearance has been obtained on the basis of solid evidence of safety and efficacy, the others being the inner thighs, outer thighs, flanks or love handles, and abdomen.
The pivotal trial included 60 patients who underwent CoolSculpting for a double chin, or submental fullness, using a prototype of the device known as the CoolMini submental applicator, a small-volume vacuum delivery cup. The patient’s double chin was placed in the applicator, then a 60-minute–long treatment cycle was delivered to that area at –10° C. An optional second treatment could be delivered 6 weeks later.
There were no procedure-related serious adverse events. Ultrasound assessment carried out 12 weeks after the final cryolipolysis treatment showed a mean 2-mm reduction in fat layer thickness. Eighty-three percent of patients declared themselves satisfied, 77% reported visible fat reduction, 77% reported that they felt their appearance had improved, 76% found the procedure comfortable, and 80% indicated they would recommend submental cryolipolysis to a friend (Lasers Surg Med. 2016 Jan;48:3-13).
Dr. Kilmer noted that cryolipolysis has been cleared by the FDA for fat reduction since 2010. It works by inducing a delayed slow death of fat cells via apoptosis. There is no immediate effect and the noninvasive procedure involves no anesthetics. There is very little inflammation, discomfort, or downtime for recovery. The typical result is roughly a 20% loss in fat cells in treated areas.
She offered a couple of practical tips regarding cryolipolysis for reduction of submental fat. First, the entire targeted area of submental fat must be able to fit inside the applicator. And after successful cryolipolysis, any residual areas of fat cells will have to be targeted using injections of deoxycholic acid (Kybella), because a small pocket of submental fat won’t get sucked up into the CoolMini applicator. (Deoxycholic acid was approved by the FDA in 2015, for treating moderate to severe submental fat in adults.)
“Actually, we use both treatments together on most people. When they have a lot of fat we start out by killing it with cryolipolysis. Then when it gets smaller we trim it down with deoxycholic acid, often with a neuromodulator to deal with the platysmal bands,” Dr. Kilmer said.
She reported serving on medical advisory boards for Zeltiq and a handful of other dermatologic device companies and receiving research funding from half a dozen companies.
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