The maximum adipose tissue temperatures at and over the apoptotic threshold of 43°C were reached and maintained in both G1 and G2. The skin surface temperature was slightly higher in G2 after 20 min than in G1 after 30 min, but was still below 43°C. Gross and magnified observation revealed no appreciable differences or thermally-mediated damage between the skin of either of the two groups after the treatments or during the 90-day follow-up period. No lasting erythema or any other adverse event was seen in either group. The liver enzyme markers showed very similar patterns over the 4 weeks of treatment compared with baseline with no levels outside of the normal range. Triglycerides were all within normal rage with no significant differences between the groups. Remarkably similar patterns were noted for the ELISAs in both groups performed over the 4 weeks of treatment and at periods during the 90-day follow-up with no notable abnormal changes in levels. Staining patterns for both G1 and G2 specimens were similar for all stain types during treatment and the 90-day follow-up, showing decreased numbers of adipocytes by the 90-day point. The ultrasound findings revealed a 44.8% and 55.6% decrease in the adipose layer for G1 and G2, respectively, at the 90-day assessment. The 200 W AiRF treatment for 30 min (G1) and the 300 W AiRF treatment for 20 min (G2) produced very similar results in the porcine model for all assessments and at all assessment points during and up to 90 days after treatment, with slightly better findings suggested for G2. Based on the above findings, the two different settings, delivering the same dose, produced good results with no skin damage and no adverse events. This has implications in busy clinics for AiRF treatment, where the shorter treatment time could represent time saving for the clinic and the patient without compromising safety and giving equal if not better efficacy.
Background and Aims: A paradigm shift towards noninvasive body contouring has occurred over the past few years. Radiofrequency (RF) is one popular treatment method. Noncontact-type RF systems with frequencies in the tens of megahertz represent a novel approach. The current pilot study investigated the efficacy of an interesting combination of extracorporeal shock wave therapy (ESWT) and an apoptosis-inducing RF (AiRF) system for circumferential reduction. Subjects and Methods: Twenty-seven females, ages ranging from 13-69 years, (mean age 37.96 years) participated in the study. They were assigned to two treatment-based groups: Group A (n=19) and Group B (n=8). A voluntary daily dietary restriction plan of 500 kcal was put in place for all subjects. A combination of two different devices was used; an extracorporeal shock wave therapy (ESWT) system and a 27.12 MHz AiRF system. Either 4 (n=28) or 6 sessions (n=19) were given, one week apart. In Group A, the ESWT was applied before the RF with the reverse order of application in Group B. Weight and waist circumference were noted at baseline, then one week after the 4th and the 6th treatment sessions at which points clinical photography was also obtained. Results: All patients showed statistically significant waist circumferential loss in both the 4- and 6-week treated groups: Group A, 6.3 cm and 8.8 cm; Group B, 5.9 cm and 6.4 cm, respectively. Greater circumference loss tended to be seen in Group A in both groups, but without statistical significance. No patient complained of pain during or after the treatment sessions, and there were no adverse events. Conclusions: This pilot study showed that the combination of ESWT and AiRF was safe and effective for significant waist circumferential reduction. The results tended to be better when ESWT was applied before AiRF, although the difference was not significant.
Background and Objectives: Radiofrequency (RF) technology has been developed as a noninvasive method to reduce subcutaneous abdominal fat. The aim of this study was to measure the changes of human skin surface temperature and human subcutaneous fat layer temperature, as well as to evaluate the histologic change in porcine adipocytes during and after treatment with contactless apoptosis-inducing RF device. Materials and Methods: A single pig was treated with RF device for 30 minutes at maximum power of 200 Watts. The skin was biopsied and evaluated immediately after the therapy. A female human volunteer was also treated with RF device for 45 minutes. The temperatures of the skin surface and subcutaneous fat layer were measured during the therapy. Results: Skin biopsy specimens from the pig revealed changes in the adipocyte shape and size. Many of the adipocytes had shrunken, with a few showing consensed chromatin and fragmented nuclei, reflecting signs of adipocyte apoptosis. In the human volunteer, subcutaneous fat layer maintained a temperature of 43–45°C, while the skin surface temperature did not reach 43°C during the treatment. Conclusion: The contactless selective RF device achieved the ideal temperature for fat reduction in subcutaneous fat layer during the treatment, while maintaining skin surface temperate below the threshold of heat-induced pain for humans. Apoptosis of subcutaneous adipocytes was confirmed in porcine skin. Further clinical trials are necessary to evaluate the efficacy and safety.