Cryolipolysis (coolshaping and coolsculpting) uses controlled cooling to damage adipocytes noninvasively for fat reduction, fat removal and body shaping. The selective fat damage results from the greater susceptibility of lipid-rich adipocytes to cold injury compared with surrounding water-rich cells. Coolsculpting and cool shaping have been shown to safely and effectively reduce subcutaneous fat and currently has US Food and Drug Administration clearance for treatment of the flanks, abdomen, thighs, submental area, back, bra area, underneath the buttocks, and arms.
Clinical studies have investigated the safety and efficacy of cryolipolysis (coolshaping and coolsculpting) and treatments for a subcutaneous fat reduction in numerous areas of the body, including the abdomen, flanks, inner thighs, outer thighs, arms, and chest. Noninvasive reduction of submental fat has currently been an area of interest in aesthetic medicine owing to recent advances in technologies, increased public awareness, and a strong record of safety and efficacy for fat reduction. A previous study of coolshaping and coolsculpting of the submental area (double chin) demonstrated that the procedure was safe and well tolerated, produced a visible improvement to the neck contour, and generated high patient satisfaction. This post is to discuss a study performed by Bloom et al. “Safety and Efficacy of Bilateral Submental Cryolipolysis With Quantified 3-Dimensional Imaging of Fat Reduction and Skin Tightening” JAMA Facial Plast Surg. 2017;19(5):350-357.
The study population consisted of 14 participants who were treated from January 22 to June 30, 2016, in the lateral and central submental area for fat reduction at the double chin area. A small-volume cup applicator was used to administer two cryolipolysis treatments via coolsculpting/coolshaping, delivered in 45-minute treatment cycles in 2 sessions. For the first treatment session, all participants received bilateral treatments with approximately 20% overlap of the treatment area. Each participant underwent up to 2 treatment cycles per visit to the lateral and central submental areas based on the investigators’ assessment of the submental area, with 2 treatment visits spaced 6 weeks apart. Each treatment consisted of a maximum of 2 and a minimum of one –11°C, 45-minute cooling cycles using a commercially available, small-volume vacuum cup cryolipolysis applicator (CoolMini Applicator, CoolSculpting System; ZELTIQ Aesthetics). The applicator opening is approximately 2.5 × 7.5 cm and has a concave shape to match the typical curvature of the submental tissue. To mark the treatment areas, the participant’s head was positioned in a neutral position, and a treatment area template was positioned to achieve approximately 20% overlap at the center of the submental area. The method of administration of cryolipolysis treatment was similar to the procedure used in a prior study.A protective transparent coupling gel was applied to the skin, and then the small-volume cup applicator was fitted with a new gel trap (a disposable component of the applicator that prevents gel from being drawn into the vacuum line). After vacuum suction was initiated, the applicator was positioned over the marked treatment area and then placed onto the skin. The vacuum drew the target tissue into the cup, filling it the full depth of 2 cm. The vacuum force adhered the applicator to the treatment area with minimal discomfort, and cloth adhesive straps were attached to a pillow to provide additional support throughout the cooling treatment. At the conclusion of the treatment cycle, the applicator was removed and the treatment area was manually massaged for 2 minutes, allowing the tissue to rewarm and regain its original shape. On the first treatment visit, all 14 participants received 2 bilateral treatment cycles, overlapping approximately 20%. On the second treatment visit, 12 participants received 2 bilateral cycles, and 2 participants received 1 centered cycle because they were deemed not to have sufficient remaining submental fat to allow placement of 2 treatment cycles. At the 6-week follow-up visit, participants were reassessed to determine whether they would benefit from a second treatment and to determine the number of cycles needed to achieve the optimal aesthetic result, and then they were treated a second time. Among the 14 participants (12 women and 2 men; mean [SD] age, 50.5 [10.4] years), the adverse effects of the procedure were typically mild and included numbness and tingling, which resolved without intervention by the final 12-week follow-up visit. An independent review of digital photographs revealed an 81.0% (95% CI, 65.9%-91.4%; P = .02) correct identification rate of the pretreatment and posttreatment images. Caliper measurements demonstrated a mean (SD) fat layer reduction of 2.3 (0.8) mm (range, 0.7-3.5 mm). Three-dimensional imaging revealed a mean (SD) reduction in fat volume of 4.82 (11.42) cm3 (from a reduction of 32.69 cm3 to an increase of 13.85 cm3), in skin surface area of 1.29 (1.42) cm2 (from a reduction of 3.18 cm2 to an increase of 0.99 cm2), and in fat thickness of 3.77 (3.59) mm (from reduction of 13.10 mm to an increase of 0.47 mm). Results of participant surveys indicated that 13 participants (93%) were satisfied with the cryolipolysis treatment. All participants remained within the allowed ±5% weight change limit; therefore, no participants were excluded from the treatment efficacy analysis owing to weight change. The weight change from the first treatment visit to the 12-week follow-up visit was a mean (SD) decrease of 0.5 (2.3) kg (1.2 [5.0] lb). On completion of the treatment cycle and immediately following the removal of the cryolipolysis applicator, photographs were taken prior to manual massage of the treatment area. The immediate posttreatment images in demonstrate the typical firm solidified tissue for the first of 2 bilateral treatments. The tissue was stiff and erythematous immediately after treatment but quickly softened and rewarmed with manual massage. As shown in the infrared images in, the entire tissue within the treatment cup attained uniform cooling, and localized warming is evident presumably owing to blood flow.
Participant 14 at Baseline and 12 Weeks After Treatment
Weight change, 0.05 kg (0.1 lb) (0.05%) from baseline.
Images were quantified to evaluate changes between baseline and 12 weeks after treatment.
Conclusions and Relevance Although safe and efficacious central submental cryolipolysis (coolshaping/ coolsculpting) have been reported; this is the first clinical study of cryolipolysis (coolshaping/ coolsculpting for treatment of the entire submental area using overlapping bilateral treatments and shorter treatment duration. The study demonstrates that bilateral submental cryolipolysis is well tolerated and produces visible and significant fat layer reduction and effective permanent solution to the double chin problem and body shaping in general
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