Our study revealed a vigorous wound healing response is initiated post-treatment, with progressive increase in inflammatory cell infiltration from day 2 through 10 weeks. An active dermal remodeling process driven by the collagen chaperone HSP47 led to complete replacement of RFTZs with new collagen by 10 weeks post-treatment. Furthermore, using both immunohistochemical and PCR studies, we successfully demonstrated for the first time evidence of profound neoelastogenesis following RF treatment of human skin. The combination of neoelastogenesis and neocollagenesis induced by treatment with the FRF system may provide a reliable treatment option for skin laxity and/or rhytids.

Background and Objectives: Noninvasive bipolar and monopolar radiofrequency (RF) deep dermal heating devices have previously been described. A novel minimally invasive RF device employing a bipolar microneedle electrode system is introduced and its resultant thermal effects on human skin in vivo were characterized for the first time. Study Design/Materials and Methods: An investigational 35 W RF device was configured to operate in bipolar mode delivering energy directly within the dermis using 5 microneedle electrode pairs with real-time feedback of tissue temperature for treatment control. Superficial cooling was achieved using a Peltier device. A range of pulse durations between 1 and 25 seconds, and lesion temperatures between 60 and 80 C were tested in vivo on 15 human subjects. Thermal effects were assessed histologically using either hematoxylin & eosin (H&E) or nitroblue-tetrazoliumchloride (NBTC) staining. Treatment effects and adverse events were also monitored clinically. Results: The investigational bipolar RF device delivered controlled heating within dermal tissue. Histological staining with H&E revealed the presence of zones of denatured collagen within the reticular dermis. Lesions were generated at preselected temperatures between 60 and 80 C. Fractional lesions separated by zones of sparing as well as contiguous lesion patterns were demonstrated. Histological staining with H&E and NBTC revealed sparing of adnexal structures and adipose tissue. No major adverse events were observed. Conclusions: A novel fractional RF device utilizing a minimally invasive bipolar microneedle delivery system for the treatment of human tissue was developed. Treatment of 15 human subjects illustrated the controlled creation of dermally located thermal coagulation zones, herein known as radiofrequency thermal zones. We discovered that varying the pulse length allowed for fractional sparing of dermal tissue. To our knowledge, this is the first report to describe use of a direct real-time temperature and impedance feedback system to control energy delivery during deep dermal heating. Lasers Surg. Med. 41:87--95, 2009.

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FEA of the Bipolar FRF system revealed that isotherms were mainly within the dermis. Lesion volume was found to be less sensitive to changes in electrical conductivity than to target temperature and duration. Simulation results matched well the in vivo lesion dimensions. To our knowledge, this is the first model of bipolar FRF treatment capable of accurately predicting the thermal response of human skin in vivo. The findings of this study allow for the development of accurate dose-response curves to aid physicians in parameter selection and achieving efficacy and safety profiles.

Elastometry data showed an average decrease in Young's Modulus and retraction time, both of which suggest that radiofrequency bipolar treatment resulted in more youthful skin. Better mechanical characteristics were consistent with improvements in wrinkles, laxity, and skin quality and appearance.