CLINICAL EFFECTIVENESS OF NON-INVASIVE SELECTIVE CRYOLIPOLYSIS

Unwanted excess subcutaneous fat negatively impacts not only body shape and image, but also causes various chronic diseases. Therefore, concerns of the public, physicians, and scientists have been growing, and the media has been promoting the image of a slim body as the virtue of beauty and health.

Among the numerous therapeutic modalities that have been developed so far, liposuction still remains the most common surgical cosmetic procedure. Although liposuction is an effective therapeutic option for the removal of fat and can be safely performed as an outpatient procedure, it is an invasive method with surgical risks, such as infection, scarring, hematoma, deep vein thrombosis, and pulmonary embolism, in addition to the specific risks associated with general anesthesia (1,2).

A non-invasive procedure that also enables effective fat removal is necessary because of the potential side effects of liposuction. Many such non-invasive treatment methods have been developed, including endermologie (LPG Systems, Valence, France), radiofrequency treatment, and light-based treatment (lasers or low level light therapy)(3 – 5). However, the therapeutic results of these methods are not as satisfactory and they are therefore used as adjunct methods to liposuction. High intensity focused ultrasound (HIFU) is regarded as a treatment that safely and effectively reduces subcutaneous fat tissues (6); however, it is still difficult to use widely because of the pain and high cost of consumable devices.

Non-invasive selective cryolipolysis is a new technology that uses cold exposure or energy extraction to cause localized panniculitis and fat modulation. This technology is based on clinical observations that cold exposure, under the proper circumstances, can result in localized panniculitis. This panniculitis ultimately results in the reduction and clearance of adipose tissue without injury to the surrounding normal tissue (7). Micool™ (Hironic Co., Seongnam, Korea) is a non-invasive selective cryolipolysis device and was approved by the Ministry of Food and Drug Safety (MFDS) of the Korean government in 2013. Several articles have been published reporting the efficacy of non-invasive devices (Zeltiq Aesthetics, Pleasanton, CA), but nothing has been documented related to Micool™, despite its growing clinical usage in Korea. This study aimed to determine the effectiveness of the Micool™ cryolipolysis device and ensure that it does not damage the overlying skin or cause significant side effects.

The treatments delivered to different anatomic sites were also analyzed by gender. Men almost exclusively received treatment to the love handles (50.0%, n=2) and belly (50.0%, n=2). Women, in comparison, received treatment over a much wider range of areas, including the love handles (36.4%, n=4), upper hip (18.2%, n=2), inner thigh (18.2%, n=2), bra line (9.1%, n=1), belly (9.1%, n=1), and under the buttocks (9.1%, n=1). The treatment sites were also analyzed by patient age range. The patients were divided into 2 groups, 20 to 29 years old and more than 30 years old. The number of patients in each group was similar, with 8 for the former and 7 for the latter; however, the composition was quite different. The treatment sites of the former group were love handles (37.5%, n=3), upper hip (25.0%, n=2), inner thigh (25.0%, n=2), and banana muffin (12.5%, n=1). The latter group received treatments of the love handles (42.9%, n=3), belly (42.9%, n=3), and bra line (14.3%, n=1). It can be assumed that both groups were interested in treatment of the love handles, but the younger group desired modification of the thigh or hip area and the older group was more concerned with their belly.

Results of both the objective and subjective assessments were revealed to be statistically significant (p < 0.05) compared to the baseline state. The average point of the objective assessment was 1.7, which implies good to excellent improvement or 50% to 100% subcutaneous fat reduction. The average of the subjective assessment was 2.1, indicating moderately satisfactory results. The assessments were also analyzed by gender and treatment site. The average values of the objective and subjective assessments of male patients were 1.5 and 1.8, respectively. The average points for female subjects were 1.8 and 2.2, respectively. It seemed that the male patients showed slightly more favorable results with cryolipolysis than their female counterparts. The most satisfactory treatment site was area under the buttocks, followed by the love handle. The average values for the objective and subjective assessments of under the buttocks were 1.0 and 1.0, and the love handle showed points of 1.3 and 1.5, respectively. Clinical photos of love handle treatment by cryolipolysis are described in Figure 1. The male patients received cryolipolysis treatment once on the right and once on the left love handle area. After 3 months, they all showed excellent improvement and expressed significant satisfaction with the results. The most dissatisfactory area was the bra line followed by the inner thigh. The average values for both the objective and subjective assessments of the bra line were 3.0 and 4.0, respectively, and the values for the inner thigh were 2.0 and 3.0, respectively. Each subject was closely observed and managed for possible complications during the entire course of the study. All patients experienced immediate erythema (Figure 2a) and minor pain for several hours, but these symptoms vanished within one day without specific management. Bruising (Figure 2b) emerged in some patients at the treatment site and disappeared within 2 to 5 days without further treatment. Neurologic complications, such as tenderness, dulling of sensation or numbness, or tingling sensation, were not reported until 3 months after the last procedure. All patients were also shown to have no other long-lasting symptoms or discomfort at the last questionnaire 3 months after the last treatment.