A controlled internal electric field perpendicular to the skin-fat interface is selective in heating up fat and, consequently, has the ability to induce lethal thermal damage to subcutaneous adipose tissues while sparing overlying and underlying tissues. In vitro adipocyte cells are heat sensitive to thermal exposures of 50 and 45 degrees C on the order of minutes, 1 and 3 minutes, respectively. In vivo, 15 minutes thermal exposures to 43-45 degrees C result in a delayed adipocyte cellular death response-in this study, 9 days. The novel RF device presented herein effectively delivers therapeutic thermal exposures to subcutaneous adipose tissues while protecting epidermal and dermal layers.
Background and Objectives: Demand for non-invasive body sculpting procedures has been steadily increasing, spurring the development of new energy-based technologies. This study assessed the safety and efficacy of a new monopolar 2 MHz radiofrequency (RF) device for fat reduction of the flanks and abdomen. Study Design/Materials and Methods: Nineteen subjects from two clinical sites were enrolled in this study and received a single 15-minute treatment with the 2 MHz RF device. Up to six applicators were placed on the abdomen and/or flanks during the treatment. Follow-up assessments were scheduled 12 weeks after treatment. Efficacy evaluations included live ratings and Global Aesthetic Improvement Scale (GAIS) ratings by blinded investigators, ultrasound measurements of fat thickness, and patient-reported outcomes before and after treatment. Results: Investigator assessments showed more than one-point change in the GAIS scale at the 12-week followup visit. Ultrasound measurements revealed a significant reduction in fat thickness in both the abdomen (average 24%) and the flanks (22%). The majority of the patients were satisfied with the treatment and mild self-resolving side effects were observed. No serious adverse events were reported. Conclusions: Treatment of local adiposities with a new monopolar 2 MHz radiofrequency device leads to improvement of body contour with no downtime or side effects. Lasers Surg. Med.
BACKGROUND
Little literature exits on the mechanism of action of implanted polymethylmethacrylate (PMMA) filler.
OBJECTIVE
To characterize PMMA-induced dermal extracellular matrix production in the skin.
MATERIALS AND METHODS
Single-center, open-label prospective study in healthy volunteers undergoing removal of redundant skin was injected intradermally and subdermally with PMMA dermal filler (Bellafill). Punch biopsies were harvested over a time course and evaluated for the deposition of collagen-3 and procollagen-1, proteoglycans and elastin using immunohistochemistry. Blinded histopathologic readings were performed by a dermatopathologist to characterize the nature of the dermal extracellular matrix findings.
RESULTS
Normal inflammatory infiltrate was exhibited at all timepoints after PMMA injection with an influx of fibroblasts and new vasculature. Tissue proteoglycans were noted within the injectate beginning at Week 1 and persisted through the study end point. Increased collagen Type 3 was evident following the first week after injection, peaked at Month 2 and diminished through Months 3 through 6. Procollagen-1 was noted at Month 1 and continued to increase in intensity and organization through the study end point (6 months). Elastin staining was inconclusive. Polymethylmethacrylate microspheres remained within the initial injection area and became encapsulated within new collagen fibers. The growth and pattern of new connective tissue mimicked a normal wound healing response.
CONCLUSION
Polymethylmethacrylate-collagen gel filler stimulates collagen-3 and procollagen-1 when injected into human skin. This combination of neocollagenesis followed by microencapsulation of PMMA microspheres in the new tissue provides for long-lasting results.
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