Multi-Center Pilot Study to Evaluate the Safety Profile of High Energy Fractionated Radiofrequency With Insulated Microneedles to Multiple Levels of the Dermis
November 2016 | Volume 15 | Issue 11 | Original Article | 1308 | Copyright © 2016
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 MDg
aAboutSkin Dermatology & DermSurgery, Greenwood Village, CO bThe Aesthetic Clinique, Destin, FL cSanctuary Plastic Surgery Center, Boca Raton, FL dConnecticut Skin Institute, Stamford, CT eAesthetica Cosmetic & Laser Center, Bethlehem, PA fScripps Clinic, San Diego, CA gDr. Zena Dermatology, Newport Beach, CA
In this multi-center pilot study, the safety pro le 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 signi cant coagulative thermal injury into the dermis while sparing the epidermis from RF injury. Thirty- ve 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):1308-1312.
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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.
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.
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