Prospective Internally Controlled Blind Reviewed Clinical Evaluation of Cryolipolysis Combined With Multipolar Radiofrequency andVaripulseTechnology for Enhanced Subject Results in Circumferential Fat Reduction and Skin Laxity of the Flanks
November 2016 | Volume 15 | Issue 11 | Original Article | 1354 | Copyright © November 2016
Julius Few MD,a Michael Gold MD FAAD,b and Neil Sadick MD FACP FAACS FACPh FAADc
aThe Few Institute, Chicago, IL bGold Skin Care Center;Tennessee Clinical Research Center, Nashville,TN cDepartment of Dermatology,Weill Cornell Medical College; Sadick Dermatology, NewYork, NY
BACKGROUND: Increasing demand for non-invasive skin tightening and body contouring procedures has led to several technological in- novations in energy-based devices such as ultrasound, radiofrequency and cryolipolysis. An emerging trend in the eld is to evaluate whether combination therapies for skin laxity/body contouring using energy-based devices can deliver superior clinical results and patient satisfaction. As such, the objective of this prospective, internal-controlled, blind clinical study was to assess the safety and efficacy of cryolipolysis followed by multipolar radiofrequency with pulsed electromagnetic elds (PEMF) and adjustable pulsed suction for the treatment of skin laxity in the flanks.
METHODS: Ten subjects with focal adiposities in the anks were enrolled in the study. All subjects received one session of cryolipolysis treatment and after randomization received two sessions of radiofrequency with PEMF (spaced two weeks apart), followed by another two sessions of radiofrequency with PEMF and adjustable pulsed suction (spaced two weeks apart). Clinical photography was used to monitor the subject’s results at baseline, one week, three, and six months post treatment. Blinded reviewers and the treating inves- tigator assessed the clinical outcomes using the Global Aesthetic Improvement (GAI) scale. Side effects were recorded at every visit and patient satisfaction was noted at the one week, three and six-month follow-up using a 5-scale subject satisfaction assessment questionnaire.
RESULTS: Analysis of the blinded investigator ratings demonstrated statistical significant enhanced skin laxity mean improvement of 1 grade on the GAI scale in subject treated with the combination treatment (cryolipolysis+RF/PEMF/suction) compared with the cryolipolysis treatment alone. The unblinded investigator GAI ratings also showed enhanced (20%) mean improvement of laxity in the combination treated subjects versus those receiving cryolipolysis alone. Over half of the participants reported satisfaction with both treatment results, but there was a 10% statistically significant higher satisfaction rating of the outcomes in the flank treated with the combination treatment. Procedures were well tolerated, side effects were transient and self-resolving and no unexpected adverse effects were reported for the duration of the study.
CONCLUSION: The results of this study show that the combination of multipolar RF with PEMF/suction following cryolipolysis is a safe, effective, and painless approach to enhance skin tightening following fat reduction procedures in the flanks. J Drugs Dermatol. 2016;15(11):1354-1358.
Photoepilation is one of the top five non-invasive medaesthetic procedures performed in the United States, with over 800,000 procedures performed in 2014 alone.1 The technique has become an attractive long-term solution for both hirsutism and hypertrichosis, as well as for normally distributed but unwanted hair growth. It is most widely exploited by Caucasian (73.2%) and female (87.1%) patients within the 35-50-year-old age group (44.9%).1 Photoepilation is founded upon pulsed delivery of light energy to hair follicles, where it is efficiently absorbed by melanin of the residing stem cells and dermal papilla. The inherent optical and thermal properties of the pigmented cells enable selective photothermolysis of the hair and its follicle, with permanent damage to the follicular epithelium and consequential disruption of hair growth.3 At the same time, overlying skin and proximal cells or tissues are spared, due to their lower optical absorption at the deployed wavelength with the appropriate pulse width.Maximal treatment selectivity is secured by laser hair removal devices combining wavelengths selectively absorbed by melanin (700-1200 nm), pulse durations equal to or shorter than the thermal relaxation time of the follicle and high peak power. However, darker skin phototypes with high epidermal melanin concentrations, compete with the targeted hairs and absorb laser energy, which can lead to thermal skin damage18 and reduced therapeutic efficacy. Devices using longer wavelengths of light provide for reduced scatter and deeper light penetration, most advantageous for skin types with high epidermal melanin concentrations,14,19 but require higher fluence to compensate for the reduced thermal effect within the follicle. Overall, these lasers have demonstrated particular clinical relevance in darker skin phototypes but generally require multiple treatment sessions to obtain satisfactory results.4,8,14,16In addition to the aforementioned tunable optical parameters, spot size inversely correlates with dermal scattering, where larger spot sizes are associated with deeper penetration and a consequential reduction in fluence demands.9 Thus, when designed in conjunction with a large spot size, long-wavelength lasers reduce the epidermal-to-follicular energy absorption ratios, rendering them particularly suitable for dark-skinned patients.The LightSheer Infinity with the HS handpiece (Lumenis Ltd.), designed for delivery of fluences of up to 14 J/cm2 over a 22x35 mm area, is equipped with a vacuum chamber, which