SPECIAL TOPIC. AboutSkin Dermatology & DermSurgery, Greenwood Village, CO b. The Aesthetic Clinique, Destin, FL c

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1 November Volume 15 Issue 11 Copyright 2016 ORIGINAL ARTICLES SPECIAL TOPIC Multi-Center Pilot Study to Evaluate the Safety Profile of High Energy Fractionated Radiofrequency With Insulated Microneedles to Multiple Levels of the Dermis. Joel L. Cohen MD, a Steven F. Weiner, MD, b Jason N. Pozner, MD, c Omar A. Ibrahimi MD PhD, d David B. Vasily MD, e E. Victor Ross MD, f and Zena Gabriel MD g ABSTRACT a AboutSkin Dermatology & DermSurgery, Greenwood Village, CO b The Aesthetic Clinique, Destin, FL c Sanctuary Plastic Surgery Center, Boca Raton, FL d Connecticut Skin Institute, Stamford, CT e Aesthetica Cosmetic & Laser Center, Bethlehem, PA f Scripps Clinic, San Diego, CA g Dr. Zena Dermatology, Newport Beach, CA In this multi-center pilot study, the safety profile of high intensity focused radiofrequency (RF) delivered to the dermis was evaluated for safety in the treatment of the aging neck and face. A newly designed insulated microneedle system delivers a significant coagulative thermal injury into the dermis while sparing the epidermis from RF injury. Thirty-five healthy subjects from seven aesthetic practices were evaluated, and data from each were incorporated in this case report. The subjects received a single treatment using settings that delivered the highest RF energies suggested from the new recommended protocols. The depth of thermal delivery was adjusted before each pass and all subjects received a minimum of two to three passes to the treated areas. Before and after photographs along with adverse effects were recorded. This case report demonstrates the ability to deliver significant RF thermal injury to several layers of the dermis with insulated microneedles safely with little injury to the epidermis and minimum downtime. J Drugs Dermatol. 2016;15(11): INTRODUCTION The request for an effective method, with little to no downtime, to treat laxity on the aging neck and face is still in demand by today s aesthetic patient. Fractional laser resurfacing has been instrumental in the treatment of skin laxity and the aging neck and is today considered a standard for skin rejuvenation. 1-2 Following the development of fractional technology with lasers, other energy sources were also used in fractionated patterns, such as radiofrequency (RF) and ultrasound. One of the limitations in treating the neck and face with fractional lasers is the risk of hyperpigmentation, particularly in ethnic and darker Fitzpatrick skin phototypes. 3 Because RF energy is not preferentially absorbed by melanin and can be delivered through an array of insulated microneedles to precise depths that spare the epidermis, it has been explored as a treatment in rejuvenation protocols. Having insulated needles, except for the active tip, maximum thermal coagulative injury zones can be delivered to the targeted layers of the dermis while only slight mechanical injury is caused to the epidermis. As a result, patient downtime and recovery are minimized as are risks of hyperpigmentation. Here we report on the safety profile using this device on the face and neck with a case series of 35 patients treated at seven different aesthetic practices using fractionated RF energy delivered through insulated microneedles. METHODS The study device used (INFINI, Lutronic, Inc., Burlington, MA) delivers high intensity focused bipolar radiofrequency energy in a fractional pattern through an array of insulated 200-micron diameter microneedles that are arranged in a 7 X 7 array (49 microneedles) with a total spot size of 10mm X 10mm. A new needle design with enhanced pin-to-pin transmission of RF energy between the 49 gold plated needles was used. Penetration depth of the microneedles can be controlled from 0.5 mm to 3.5 mm which allows for the creation of a latticework of focal RF injuries, thus customizing the treatment, which, in this case series, allowed use of the highest recommended energy settings. The delivered RF energy can be selected by adjustment of the power setting up to 50 Watts and exposure time from 10 msec to 1 second. Protocol This safety pilot study was conducted under IRB approval and all subjects provided signed, informed consent prior to enrollment. Each site treated five subjects on the face and neck

2 612 TABLE 1. Percent Incidence of Side Effects Side Effect Pre n=34 Post n=33 1 Week n=35 2 Week n=34 4 Week n=35 Blistering 0% 0% 0% 0% 0% Bronzing 24% 21% 11% 6% 0% Bruising 0% 39% 20% 0% 0% Dry/Tight 3% 27% 23% 0% 0% Edema 0% 100% 17% 3% 0% Erythema 38% 100% 26% 9% 0% Hyperpigmentation 0% 0% 0% 0% 0% Hypopigmentation 0% 0% 0% 0% 0% Infection 0% 0% 0% 0% 0% Other (Hives) 0% 0% 3% 3% 0% Other Linger 0% 0% 0% 0% 0% Peel/Flake 0% 0% 9% 0% 0% Persis Bleed 0% 18% 0% 0% 0% Petechiae 0% 52% 9% 0% 0% Post-Tx Discomfort 0% 36% 0% 0% 0% Texture Irregularity 0% 0% 3% 3% 0% with the highest energy settings for each combination of location and pass. Over the 3-pass procedure on the lower face and submental area subjects received a total delivered energy of 11J. On the neck in 3-passes, 8J was delivered, and on the upper face 4 to 5 joules was delivered in 2 passes. Subjects received a total of 3.8 to 4.2KJ total energy delivered during the course of the entire procedures which were typically comprised of about 1000 pulses, and were completed in 30 minutes. All subjects received topical anesthetic for approximately 60 minutes prior to treatment, and many also received adjunctive air-cooling to improve comfort. Standardized photography was taken before and immediately after treatment, and at all follow-up visits, FIGURE 1. Subject before and immediately after INFINI treatment of the face using highest recommended energy settings. Mild erythema resolved completely at 1-week follow-up. Photo courtesy of Joel Cohen, MD.

3 613 FIGURE 2. Subject before and immediately after INFINI treatment of the face and neck using highest recommended energy settings. Moderate erythema resolved completely at 1-week follow-up. Photos courtesy of Joel Cohen, MD. along with clinical observation and recording of all side effects using a 5-point scale (0 = none, 1= trace, 2= mild, 3=moderate and 4=severe). All subjects returned for follow-up visits one week after treatment. Any unresolved side effects were then observed again at two weeks or later as needed until all side effects resolved. RESULTS Of the 35 subjects enrolled, 31 (88.6%) were female and 4 (11.4%) were male. Average age of 54 years (range, 27 to 68 years), though 28 of 35 (80.0%) were between 50 and 60 years of age. Most subjects had Fitzpatrick Skin Type (FST) II (n=16, 45.7%) or III (n=18, 51.4%), while 1 subject (2.9%) was FST IV. All subjects FIGURE 3. Subject before and 2 weeks after a single INFINI treatment of the face and neck demonstrating no lingering side effects as well as noticeable skin tightening. Photos courtesy of Vic Ross, MD.

4 614 FIGURE 4. Subject before and 1 week after a single INFINI treatment of the face demonstrating no lingering side effects and improved clinical appearance in skin tone and texture. Photos couresy of David Vasily, MD. tolerated treatments well and completed all clinical follow-up observations. In only 2 cases were the ratings of immediately post treatment side effects omitted. Table 1 summarizes the incident FIGURE 5. Histological H & E staining of ex vivo skin samples demonstrating clearly delineated zones of thermal coagulation following INFINI treatment. rate of side effects scored as trace or higher at each observation time point. All subjects experienced erythema and edema immediately post-treatment, though the vast majority of all side effects scored as trace or mild. Patient downtime was typically only 12 to 48 hours, and discomfort if any present after treatment dissipated in just a couple of hours or less. By 1 week, all side effects had resolved to none or trace in 27 of 35 (77.1%) subjects. By 2 weeks post-treatment, all side effects had completely resolved in 34/35 (97.1%) patients, with the exception of 1 (2.9%) subject who continued to exhibit mild erythema. The side effect profile observed in the safety test is similar to prior observations although investigators commented that erythema and edema reactions were slightly stronger and lasted slightly longer than previous settings. Overall, the updated treatment settings used with the INFINI device did not introduce any new safety issues compared to previous treatment recommendations. CONCLUSION High Intensity Focused RF with insulated microneedles is a new option to treat the aging face and neck worldwide. This multi-center 35 patient safety study demonstrates that using high energy fractionated RF focused into the dermis with

5 615 insulated microneedles is well tolerated and causes minimal side effects with minimal downtime. At the highest RF energy settings over 100mj per pin per pulse is delivered directly into the dermis and a total of approximately 4KJ is delivered during a treatment. Equivalent high-energy settings delivered with ablative of non-ablative fractional lasers would generate significantly greater side effects and downtime. The use of insulated microneedles has shown that significant energy can be delivered directly to the dermis while bypassing the epidermis during treatment and by so doing, substantially minimizes risks and discomfort to the patient. Potential advantages of this technology include the ability to treat the full spectrum of skin types with less downtime than ablative and non-ablative fractional lasers. Further, using insulated microneedles in combination with RF energy to create thermal injury of the dermis, should also prove substantially more beneficial than microneedles alone. AUTHOR CORRESPONDENCE Joel L. Cohen, MD jcohenderm@yahoo.com We are currently in the process of carrying out further studies to better characterize the efficacy of this RF modality with microneedle tip improvements and newly established optimal treatment parameters. DISCLOSURES Dr. Joel Cohen has received funding for clinical consulting and speaker honoraria. Dr. Steven Weiner has received funding for clinical consulting, studies and speaker honoraria. Dr. Jason Pozner has received funding for clinical consulting and speaker honoraria. Dr. Omar Ibrahimi has received funding for research, clinical consulting and speaker honoraria. Dr. David Vasily has received funding for clinical consulting and studies. Dr. E. Vic Ross has received funding for clinical consulting, studies and speaker honoraria. Dr. Zena Gabriel has received funding for clinical consulting and equipment loan. REFERENCES 1. Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR.Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004; 34: Tierney EP, Kouba DJ, Hanke CW. Review of fractional photothermolysis: treatment indications and efficacy. Dermatol Surg. 2009; 35: Clark CM, Silverberg JI, Alexis AF. A retrospective chart review to assess the safety of nonablative fractional laser resurfacing in Fitzpatrick skin types IV to VI. J Drugs Dermatol. 2013; 12: