A Preliminary Study on the Safety and Efficacy of a Novel Fractional CO2 Laser With Synchronous Radiofrequency Delivery

March 2014 | Volume 13 | Issue 3 | Original Article | 299 | Copyright © March 2014


Robert H. Gotkin MD FACSa,c and Deborah S. Sarnoff MD FAAD FACPb,c

aDepartment of Surgery, Division of Plastic Surgery, North Shore/LIJ Lenox Hill Hospital, Private practice in Plastic Surgery, New York, NY bClinical Professor, Department of Dermatology, New York University School of Medicine cCosmetique Dermatology, Laser & Plastic Surgery, LLP, New York, NY

Abstract
Building upon the fractional CO2 technology incorporated into the first generation SmartXide DOT (DEKA / ElEn, SpA, Calenzano, Italy) introduced in the U.S. in 2008, a second generation SmartXide Quadro has recently been introduced. This is a versatile device that has the ability to combine fractional CO2 laser output for skin resurfacing with the synchronous delivery of bipolar radiofrequency (RF) energy for deeper, more diffuse heating. A pilot study was undertaken to demonstrate the safety and efficacy of the SmartXide Quadro, employing both fractional CO2 laser output combined with the synchronous delivery of radiofrequency energy for the treatment of facial rhytides and acne scars. Ten patients, all women, six with facial rhytides and four with acne scarring, were treated with the SmartXide Quadro, a variably pulsed CO2 laser with Pulse Shape Design® technology, a microablative DOT scanner and synchronized bipolar RF emission. Each patient was treated with a single fractional CO2 laser-RF treatment; laser and RF parameters varied according to the severity of the rhytides or acne scars and were based upon both manufacturer-recommended settings and surgeon experience. Follow-up was at three days, one week, 2 weeks, and one month, three months, and six months after treatment. Results were judged by comparison of preoperative and post-operative photos evaluated by independent physicians, preoperative and post-operative grading by treating physicians, subjective evaluation of results by the patients themselves, and tabulation and categorization of adverse events (AEs). The SmartXide Quadro variably pulsed CO2 laser with a microablative DOT scanner, with synchronous delivery of bipolar RF energy emission, proved to be both safe and effective in the treatment of facial rhytides and acne scars. The single treatment protocol was well tolerated and recovery was similar to fractional CO2 laser skin resurfacing alone. The AEs were minimal and no significant complications occurred.

J Drugs Dermatol. 2014;13(3):299-304.

INTRODUCTION AND BACKGROUND

Carbon dioxide (CO2) laser skin resurfacing has been the “gold standard” for cutaneous facial resurfacing of photo-damaged skin since its emergence in the marketplace in the mid-1990s.1-4 Fully ablative CO2 laser (λ = 10,600 nm) technology was excellent for the treatment of facial wrinkles,1-3 acne scars,5-6 sun damage and solar elastosis, but fell into some disfavor due to its inability to be used off the face; its requirement for effective anesthesia; the nature of and downtime associated with recovery following treatment; and the significant risk of dyschromia and scarring. Prolonged post-operative erythema and transient hyperpigmentation were common findings; late (greater than one year post-operatively) hypopigmentation was also not uncommon. These side effects and complications plagued even the most cautious practitioners and well-chosen patients.7-14
The concept of fractional photothermolysis (FP) was described by Manstein et al, in 2004.15 Fractional photothermolysis heats only a fraction of the epidermal and/or dermal architecture leaving intervening areas unchanged. These intact bridges of unaltered skin between the microscopic treatment zones (MTZ) result in rapid healing because the healing occurs not only from the adnexa, but also from the adjacent intact skin bridges. The combination of fractional photothermolysis and CO2 lasers gave rise to the fractional or micro-ablative CO2 laser technology used so widely today.16-17 Ablative fractional skin resurfacing with a CO2 laser ablates portions of both the epidermis and the dermis.18-19 It successfully treats wrinkles, acne scars and other types of scars, striae, benign pigmented lesions such as lentigines, solar elastosis and others features of aged or photo-damaged skin.20-22 Due to the inherent technologic design of FP, it can be used on the face and elsewhere on the body; such areas as the neck, chest, and upper and lower extremities can be treated safely with ablative fractional resurfacing. Furthermore, concurrent full-face fractional ablative CO2 laser skin resurfacing can be safely performed with a facelift in order to address rhytides and solar elastosis not ameliorated during a rhytidectomy.
In addition to being able to be used off the face, this fractionally ablative technology also can reduce healing and downtime as well as the potential for the side effects and complications associated with traditional, fully ablative CO2 laser skin resurfacing. While the ablative quality of the treatment delivers
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