UNCORRECTED PROOF. ARTICLE IN PRESS CID-06076; No of Pages 5

Transcription

1 Clinics in Dermatology (2007) xx, xxx xxx ARTICLE IN PRESS CID-06076; No of Pages Nonablative cutaneous remodeling using 3 radiofrequency devices 4 Tina S. Alster, MD a, *, Jason R. Lupton, MD b 5 6 a Washington Institute of Dermatologic Laser Surgery, Washington, DC, USA b Department of Medicine, University of California, San Diego, CA, USA 8 9 Abstract In recent years, several new radiofrequency devices have been introduced for treatment of a 10 variety of skin conditions, particularly, skin wrinkling and laxity. These nonsurgical systems induce tissue 11 tightening and contour changes through dermal collagen remodeling without disruption of the overlying 12 epidermis, obviating a significant recovery period or risk of serious adverse sequelae. As such, 13 radiofrequency-based systems have been used successfully for nonablative skin rejuvenation, atrophic 14 scar revision, and treatment of unwanted hair, vascular lesions, and inflammatory acne Published by Elsevier Inc Introduction 18 Because of the high demand for antiaging treatments over 19 the past decade, a proliferation of laser and light-based 20 systems were developed. Nonablative technology replaced 21 traditional ablative systems such as carbon dioxide and 22 erbium:yttrium-aluminum-garnet lasers (long considered the 23 criterion standards for skin resurfacing) because of the ability 24 of these nonablative systems to induce dermal neocollagen- 25 esis without epidermal disruption (thereby limiting adverse 26 effects and virtually eliminating postoperative recovery) Because only modest success could be achieved with most of 28 these systems, radiofrequency (RF) devices were introduced 29 to address these shortcomings and to provide the added 30 benefit of tissue tightening Radiofrequency energy has been used for more than a 32 century for a variety of medical applications, including tissue 33 electrodesiccation and electrocoagulation, 19 joint capsular 34 tightening, 20,21 corneal curvature alteration, incompetent tissue without disruption of epidermal integrity. 26 saphenous venous closure, 22 aberrant cardiac electroconduc- 35 tive ablation, 23,24 and prostate and liver neoplasm eradica- 36 tion. 25 The harnessing of RF energy to deliver heat to dermal 37 structures results in nonsurgical lifting and tightening of Because RF energy is produced by an electric current 40 rather than by a light source (as are most dermatologic 41 lasers), it is not subject to diminution by tissue scattering or 42 absorption by epidermal melanin. As such, patients of 43 different skin phototypes can be treated with RF-based 44 systems, and significant thermal energies can be generated 45 safely within the deeper tissue layers to effect collagen 46 contraction and new collagen formation. Radiofrequency 47 energy is conducted electrically to tissue, and heat is 48 produced when the tissue's inherent resistance (impedance) 49 converts the electrical current to thermal energy. This 50 reaction is dictated by the following formula: energy (J) = 51 I 2 R T (where I = current, R = tissue impedance, and T = 52 time of application). High-impedance tissues, such as 53 subcutaneous fat, generate greater heat and account for the 54 deeper thermal effects of RF devices. 55 Both monopolar and bipolar RF devices have been used 56 for cutaneous applications. Monopolar systems deliver 57 Corresponding author. Georgetown University Medical Center, Washington, DC 2005 USA. Tel.: ; fax: address: talster@skinlaser.com (T.S. Alster) X/$ see front matter 2007 Published by Elsevier Inc. doi: /j.clindermatol

2 2 T.S. Alster, J.R. Lupton 58 current through a single contact point with an accompanying 59 grounding pad that serves as a low resistance path for current 60 flow to complete the electrical circuit. Monopolar electrodes 61 concentrate most of their energy near the point of contact, 62 and energy rapidly diminishes as the current flows toward the 63 grounding electrode. Bipolar devices only pass electrical 64 current between 2 positioned electrodes applied to the skin. 65 No grounding pad is necessary with these systems because 66 no current flows throughout the rest of the body. Monopolar 67 RF devices, such as the ablative Visage (ArthroCare Corp, 68 Sunnyvale, Calif) and the nonablative ThermaCool TC 69 (Thermage Inc, Hayward, Calif), and bipolar devices, such as 70 the Aurora and Polaris (Syneron Medical Ltd, Yokneam, 71 Israel), have shown clinical utility within aesthetic medicine 72 for the treatment of excessive facial laxity and rhytide 73 reduction, leg telangiectasias, acne, and unwanted hair. In 74 particular, these systems have proven most effective for the 75 reduction of brow ptosis, prominent melolabial folds, and 76 cheek laxity Monopolar RF (ThermaCool TC) 78 The ThermaCool TC nonablative RF device delivers RF 79 energy to the skin with concomitant contact cooling and is 80 approved for the noninvasive treatment of facial rhytides by 81 the US Food and Drug Administration. This system uses a 82 high frequency generator that produces a 330-W, 6-MHz 83 monopolar current signal. A disposable membrane tip 84 encompassing a treatment area of either 1.0 or 1.5 cm 2 is 85 used with a disposable adhesive return pad that serves as the 86 grounding point. The depth of heating is dependent upon the 87 size and geometry of the treatment tip being used. A 88 conductive coupling fluid is used during treatment to 89 enhance thermal and electrical contact between the treatment 90 tip and the skin. This patented capacitive membrane tip 91 allows for delivery of deep volumes of sustained, uniform, 92 and intense heat to tissue depths of 3 to 6 mm. The treatment 93 tip creates an electrical field within the tissue by alternating 94 its charge from positive to negative 6 million times per 95 second with electrons and ions simultaneously attracted and 96 repelled from the surface. According to Ohm's law, it is the 97 tissue's resistance to the movement of these ions that 98 generates heat. 99 Immediate collagen denaturation with fibril contraction 100 and thickening occurs within treated tissues as proven with 101 ultrastructural analysis using transmission electron micro- 102 scopy. 27 An inflammatory wound healing response ensues 103 with long-term neocollagenesis effecting rhytide reduction 104 and further tissue contraction. In addition, selective heating 105 and tightening of fibrous septae within the subcutaneous 106 layer likely accounts for immediate contour changes in the 107 skin after treatment. 28 Skin surface cooling is maintained 108 before, during, and after RF delivery through the use of a 109 cryogen gas spray device. The cooling device is housed within the handpiece and delivered onto the undersurface of the tip's membrane that is in direct contact with the skin. A balance of deep tissue heating and superficial cooling is therefore produced with creation of a reverse thermal gradient; the most intense heat is delivered deep within the dermis and subcutaneous layer while the superficial layers remain relatively unaffected by thermal delivery. Several recent reports have demonstrated the safety and efficacy of RF delivery for rhytide reduction and tightening of lax facial and neck skin. The largest study, a multicenter trial by Fitzpatrick et al, 11 demonstrated clinically evident periorbital rhytide reduction and brow elevation in 86 patients treated once with this RF device. In the study, 83.2% of patients showed an improvement in periorbital rhytides of at least 1 point on the Fitzpatrick wrinkle scale 6 months after treatment. Fifty percent of patients reported being either satisfied or very satisfied with the degree of rhytide reduction, and 61.5% of patients demonstrated at least a 0.5-mm elevation of the eyebrows on objective photographic analysis. In another study, Iyer et al 29 used the ThermaCool TC RF device to treat 40 patients with redundant skin folds, photodamage, atrophic scarring, and rhytides. They showed a 30%, 50%, and 70% improvement in skin laxity and texture at 1, 2, and 3 months, respectively, after treatment. They also showed that patients who received multiple RF treatment sessions had more impressive clinical results in terms of rhytide reduction and improved skin tone compared with those who received a single treatment. Ruiz-Esparza and Gomez 10 evaluated the tissue tightening effect of one treatment session using the RF device only on preauricular anchoring points in 15 patients. Moderate softening of nasolabial folds in half of the patients treated and more than 50% improvement in cheek contouring in 60% of patients were observed. Marionette lines improved by at least 50% in most patients, but mandibular ridging and jowling responded less favorably. Only one patient developed a superficial burn that healed uneventfully. In most patients, maximum improvement appeared 12 weeks after treatment. Two more recent studies demonstrated improvements in lower face and neck laxity after a single RF treatment. The first of these studies, by Hsu and Kaminer, 12 showed that although only one third of the 16 patients treated with the ThermaCool TC RF device had satisfactory results, higher treatment energies and younger patient ages were associated with superior clinical results. Alster and Tanzi 13 drew similar conclusions in their study of 50 patients who underwent a single treatment session with the device for improvement of mild to moderate cheek or neck laxity. This latter group observed noticeable improvements in 28 of 30 patients treated for cheek laxity and 17 of 20 patients treated for neck and submandibular skin laxity. Of note, neither of these lower face or neck studies had any significant adverse effects or permanent sequelae associated with treatment. Another study also demonstrated gradual cosmetic improvements in Asian skin after a single treatment with

3 Nonablative cutaneous remodeling using radiofrequency devices the RF device for amelioration of lower cheek jowling and 167 prominent nasolabial folds. 17 Most of the 85 patients treated 168 reported high satisfaction rates for the jowls, marionette 169 lines, and nasolabial folds at 3 months, but the scores dipped 170 slightly 6 months after treatment. The authors surmised that 171 retreatments would therefore best be performed within 5 to months after the original treatment session for enhanced 173 clinical results. It was also noted that energy level selection 174 with the device is best determined by constantly evaluating 175 each individual patient's level of pain tolerance during the 176 procedure. Because of individual differences in skin 177 composition, electrical resistance within the tissue will be 178 different among patients and therefore will directly impact 179 the depth and degree of thermal deposition within the skin. 180 Radiofrequency devices have also shown promise for 181 lower eyelid rejuvenation. In 1 study, 9 patients underwent treatment session with the ThermaCool TC device for lower 183 eyelid dermatochalasis. 30 One to 3 passes of RF energy were 184 delivered to the temporal and zygomatic areas of the cheeks, 185 and all patients demonstrated clinical improvement after 186 treatment. Although this was a relatively small sampling of 187 patients, some showed continued improvement 12 months 188 after treatment. There were no complications in this study, 189 and patient satisfaction was very high. 190 The ThermaCool TC RF device has also shown efficacy 191 in the treatment of moderate to severe acne vulgaris and for 192 the amelioration of atrophic facial scarring. 31 Twenty-two 193 patients received 1 or 2 RF treatment sessions with an 194 observable dual benefit: both atrophic scarring and a 195 reduction in active cystic lesions were noted. An excellent 196 response was reported in 82% of patients, a moderate 197 response in 9% of patients, and no response in another 9%. 198 There were no permanent adverse effects, and the treatments 199 were well tolerated by all patients. The authors hypothesized 200 that RF delivery not only stimulated dermal remodeling 201 eventuating in scar reduction, but also directly inhibited 202 sebaceous gland activity to improve acne. These same 203 authors have also recently reported success with this device 204 for breast ptosis breast tissue elevations of 0.2 to 1.5 cm 205 were measured after one treatment session Recommended treatment algorithms with the ThermaCool 207 TC device have changed significantly since its introduction to 208 the medical marketplace nearly 4 years ago. Initially, patients 209 were treated with a single pass of the RF device at high energy 210 settings, often resulting in mixed clinical results and 211 significant treatment discomfort. Topical anesthetic prepara- 212 tions, cold air machines (Cryo 5; Zimmer Elektromedizin, 213 GmbH, Germany), general anesthesia, and regional nerve 214 blockade were each used with varying degrees of success to 215 mitigate treatment pain. Newer treatment guidelines that use a 216 multiple pass technique with reduced energy settings have 217 been proposed, effecting superior clinical and histologic 218 results, as well as significant reduction in patient discom- 219 fort. 15,27 Although most practitioners initially delivered to 150 pulses to the entire face and neck, current guidelines 221 advocate the use of more than 400 pulses for the same areas. Patient feedback regarding tolerability is vital during treatment to avoid excessive thermal delivery to the skin. Although topical anesthetic preparations and oral anxiolytics help intraoperatively, caution should be used with complete and total anesthesia because of its tendency to reduce subjective patient feedback, which could potentially increase the risk of epidermal injury and subsequent thermal burns. In general, there is minimal posttreatment morbidity with the ThermaCool TC RF device. Most patients experience mild erythema and edema, but these adverse effects usually subside within a few hours after treatment. There have been isolated reports of vesiculation and superficial burns after RF treatment, which have been attributed to operator error or use of excessive energy settings. Although improvement in skin laxity is not as pronounced as that observed with surgical lifting procedures, the advantages of RF procedures include a virtually nonexistent postoperative recovery period and extraordinarily low risk of serious adverse effects. Patients should be counseled preoperatively regarding the potentially modest results of the treatment despite the significant skin tightening often observed immediately after the procedure (due to immediate collagen contraction and tissue edema). Combined RF and optical energy A unique combination of RF and optical energies, termed electro-optical synergy, has emerged in an attempt to address the limitations of traditional light-based systems. 16 The use of optical-based systems alone for skin rejuvenation and rhytide reduction has presented several challenges because tissue scatter and melanin absorption significantly decrease light penetration within the skin. Higher treatment energies are therefore required to adequately target dermal structures, and this, in turn, increases the risk of integumental injury and potential for adverse sequelae. With electro-optical synergy technology, optical energy is converted to heat within the tissue according to the principles of selective photothermolysis. 33 One such system (Aurora SR, Syneron) uses intense pulsed light as its optical energy source with emissions between 400 and 980, 580 and 980, and 680 and 980 nm. The optical energy is emitted to preheat dermal structures, which then creates a temperature differential between the targeted structures and the surrounding tissues; these temperature changes allow for the directed application of RF energy to dermal chromophores with less impedance. A combination of skin precooling and selective target heating using the optical energy source creates this thermal gradient. The optical energy levels are lower than those used in traditional light-based systems, thereby enabling potentially safer treatments in all skin types. The delivery of RF energy is also not impeded by skin pigmentation and therefore can be used to treat darkerskinned patients. In this bipolar system, RF energies up to 25 J/cm 3 can be generated with dermal penetration of 4 mm

4 4 T.S. Alster, J.R. Lupton 274 The Aurora SR system is used for skin rejuvenation, 275 including rhytide reduction and improvement in skin 276 texture and tone. Patients typically undergo 3 to 4 treatment 277 sessions at 3- to 4-week intervals for rejuvenation. This 278 system can also be used to treat facial acne or unwanted 279 hair. 34,35 It is approved by the Food and Drug Adminis- 280 tration for hair reduction and for the treatment of vascular 281 and pigmented lesions. This system is also reported to 282 remove lightly pigmented and white hairs because it does 283 not rely solely on melanin absorption for target destruction. 284 A recent study by Bitter and Mulholland 36 examined the 285 Aurora SR for treatment of pigmented and vascular lesions 286 of the face and neck along with wrinkle and pore size 287 reduction and rejuvenation. One hundred patients received 288 between 3 and 5 treatment sessions using a 580- to 980-nm 289 pulsed light source at fluences of 28 to 34 J/cm 2 and an RF 290 energy of 20 J/cm 3. By end-study, more than 97% of 291 patients were satisfied with the improved skin texture. 292 There was also marked diminution of mild to moderate 293 perioral, periorbital, and brow rhytides, and improvements 294 of 70% and 78% for vascular lesions and dyschromias, 295 respectively. Patients who had had undergone prior intense 296 pulsed light treatments also noticed enhanced rhytide 297 reduction with this dual-mode (optical and RF) device 298 compared with intense pulsed light alone. 299 Another dual-mode system using electro-optical synergy 300 technology is the Polaris WR system a combined 900-nm 301 diode laser with RF energy device. Optical energies are 302 delivered through a bipolar electrode tip with fluences 303 ranging from 10 to 50 J/cm 2 and RF energies of 10 to 100 J/ 304 cm 3. These energies are simultaneously delivered to the 305 tissue, and while the RF energy penetrates more deeply and 306 stimulates collagen production, the diode laser addresses 307 superficial rhytides, pigmentation, and vascularity. The systems therefore work synergistically to treat deep wrinkles 309 as well as the more superficial signs of photoaging. 310 A recent study published by Doshi and Alster was the first 311 to evaluate the dual-mode Polaris WR RF/diode laser system 312 for wrinkle reduction and skin laxity. 14 Twenty patients with 313 Fitzpatrick skin types I to III underwent 3 treatment sessions 314 at 3-week intervals. Optical energies of 32 to 40 J/cm 2 and 315 RF energies of 50 to 85 J/cm 3 were applied to effect 316 posttreatment endpoints of mild erythema and edema. 317 Multiple laser passes were performed at each session, 318 which were well tolerated. Evaluations 6 months posttreat- 319 ment demonstrated modest improvements in wrinkles in 320 most of the patients treated. Periorbital rhytides displayed 321 greater improvements than did perioral rhytides in terms of 322 mean clinical scores by end-study. There were no significant 323 adverse effects, and 80% of patients reported only mild 324 treatment-associated discomfort. Interestingly, skin laxity 325 continued to improve over the 6-month follow-up period, 326 whereas clinical improvement scores for rhytides decreased 327 slightly over time. 328 The combined RF/diode Polaris laser system also has 329 been shown to effectively remove unwanted hair, leg veins, and other vascular lesions. 34,35,37 The 900-nm diode laser targets intravascular hemoglobin or dermal pigment, whereas concomitant RF energy effects vascular or hair follicular disruption. Conclusions Nonablative skin rejuvenation with RF-based systems produces skin tightening through controlled dermal collagen contraction and neocollagenesis without integumental injury. This nonsurgical approach to rhytide reduction thereby avoids many of the inherent risks associated with surgical rhytidectomy. Experience with nonablative lasers and light sources has proven that tissue enhancement is possible with controlled dermal wounding without epidermal disruption. Radiofrequency devices are able to achieve greater depths of thermal injury with tissue penetration to the level of the dermis and subcutaneous layer without producing thermal burns. Tissue tightening and reduction of prominent nasolabial folds or jowling are produced as a result. These systems have become very popular because of their minimal morbidity and low risk for postoperative complications. There have been rapid advances in RF technology over the past few years, and the nonsurgical face or neck-lift using this energy source offers great promise to our aging population. Further studies are warranted to help elucidate ideal treatment settings particular to each system, identify the most appropriate candidates for treatment, as well as to discover novel applications for RF energy within aesthetic medicine. References 1. Alster TS. Cutaneous resurfacing with CO 2 and erbium:yag lasers: preoperative, intraoperative, and postoperative considerations. Plast Reconstr Surg 1999;103: Alster TS, Lupton JR. An overview of cutaneous laser resurfacing. Clin Plast Surg 2001;28: Alster TS, Lupton JR. Prevention and treatment of side effects and complications of cutaneous laser resurfacing. Plast Reconstr Surg 2002;109: Tanzi EL, Alster TS. Side effects and complications of variable-pulsed erbium:yag laser skin resurfacing: extended experience with 50 patients. Plast Reconstr Surg 2003;111: Alster TS, Lupton JR. Are all infrared lasers equally effective in skin rejuvenation? Semin Cutan Med Surg 2002;21: Tanzi EL, Alster TS. Comparison of a 1450-nm diode laser and a nm Nd:YAG laser in the treatment of atrophic facial scars: a prospective clinical and histologic study. Dermatol Surg 2004;30: Alster TS, Tanzi EL. Laser and light source treatment of clinical manifestations of photodamage. In: Goldberg DB, editor. Photodamaged skin. New York: Marcel Dekker, Inc; p Alster TS, Tanzi EL. Laser skin resurfacing: ablative and nonablative. In: Robinson J, Sengelman R, Siegal DM, Hanke CM, editors. Surgery of the skin. Philadelphia: Elsevier; p Alster TS, Doshi S. Ablative and nonablative laser skin resurfacing. In: Burgess C, editor. Cosmetic dermatology. Heidelberg: Springer-Verlag; p

5 Nonablative cutaneous remodeling using radiofrequency devices Ruiz-Esparza J, Gomez JB. The medical face lift: a noninvasive, 385 nonsurgical approach to tissue tightening in facial skin using 386 nonablative radiofrequency. Dermatol Surg 2003;29: Fitzpatrick R, Geronemus R, Goldberg D, et al. Multicenter study of 388 noninvasive radiofrequency for periorbital tissue tightening. Lasers 389 Surg Med 2003;33: Hsu TS, Kaminer MS. The use of nonablative radiofrequency 391 technology to tighten the lower face and neck. Semin Cutan Med 392 Surg 2003;22: Alster TS, Tanzi E. Improvement of neck and cheek laxity with a 394 nonablative radiofrequency device: a lifting experience. Dermatol Surg ;30: Nahm WK, Su TT, Rotunda AM, et al. Objective changes in brow 397 position, superior palpebral crease, peak angle of the eyebrow, and jowl 398 surface area after volumetric radiofrequency treatments to half of the 399 face. Dermatol Surg 2004;30: Fritz M, Counters JT, Zelickson BD. Radiofrequency treatment for 401 middle and lower face laxity. Arch Facial Plast Surg 2004;6: Sadick NS, Makino Y. Selective electro-thermolysis in aesthetic 403 medicine: a review. Lasers Surg Med 2004;34: Kushikata N, Negishi K, Tezuka Y, et al. Non-ablative skin 405 tightening with radiofrequency in Asian skin. Lasers Surg Med ;36: Doshi SN, Alster TS. Combination radiofrequency and diode laser for 408 treatment of facial rhytides and skin laxity. J Cosmet Laser Ther 2005;7: Alster TS. Electrosurgical ablation: a new mode of cutaneous 411 resurfacing. Plast Reconstr Surg 2001;107: Tasto JP, Ash SA. Current uses of radiofrequency in arthroscopic knee 413 surgery. Am J Knee Surg 1999;12: Hayashi K, Markel MD. Thermal capsulorrhaphy treatment of shoulder 415 instability: basic science. Clin Orthop 2001;390: Weiss RA, Weiss MA. Controlled radiofrequency endovenous occlu- 417 sion using a unique radiofrequency catheter under duplex guidance to 418 eliminate saphenous varicose vein reflux: a two year follow-up. 419 Dermatol Surg 2002;28: Trohman RG, Parrillo JE. Direct current cardioversion: indications, 421 techniques, and recent advances. Crit Care Med 2000;28:N Baszko A, Rinaldi CA, Simon RD, et al. Atrial fibrillation current and 423 future treatments: radiofrequency ablation and novel pacing techniques. 424 Int J Clin Pract 2002;56: Selli C, Scott CA, Garbagnati F, et al. Transurethral radiofrequency 425 thermal ablation of prostatic tissue: a feasibility study in humans. 426 Urology 2001;57: Carruthers A. Radiofrequency resurfacing: technique and clinical 428 review. Facial Plast Surg Clin N Am 2001;9: Zelickson BD, Kist D, Bernstein E, et al. Histological and ultra- 430 structural evaluation of the effects of a radiofrequency-based non- 431 ablative dermal remodeling device: a pilot study. Arch Dermatol ;104: Pope K, Levinson M, Ross EV. Selective fibrous septae heating: an 434 additional mechanism of action for capacitively coupled monopolar 435 Q1 radiofrequency (In press) Iyer S, Suthamjariya K, Fitzpatrick RE. Using a radiofrequency energy 437 device to treat the lower face: a treatment paradigm for a nonsurgical 438 facelift. Cosmet Dermatol 2003;16: Ruiz-Esparza J. Noninvasive lower eyelid blepharoplasty: a new 440 technique using nonablative radiofrequency on periorbital skin. 441 Dermatol Surg 2004;30: Ruiz-Esparza J, Gomez JB. Nonablative radiofrequency for active acne 443 vulgaris: the use of deep dermal heat in the treatment of moderate to 444 severe active acne vulgaris (thermotherapy): a report of 22 patients. 445 Dermatol Surg 2003;29: Ruiz-Esparza J, Gomez JB. The non-invasive, non-surgical breast lift 447 Q2 radiothermoplexy: tissue tightening via non-ablative radiofrequency. 448 [abstract]. Lasers Surg Med 2003;32: Anderson RR, Parrish JA. Selective photothermolysis: precise micro- 450 surgery by selective absorption of pulsed radiation. Science 1983;220: Sadick NS, Shaoul J. Hair removal using a combination of conducted 453 radiofrequency and optical energies an 18-month follow-up. J Cosmet 454 Laser Ther 2004;6: Sadick NS, Laughlin SA. Effective epilation of white and blond hair 456 using combined radiofrequency and optical energy. J Cosmet Laser 457 Ther 2004;6: Bitter Jr P, Mulholland S. Report of a new technique for enhanced 459 noninvasive skin rejuvenation using a dual-mode pulsed light and 460 radiofrequency energy source: selective radiothermolysis. J Cosmet 461 Laser Ther 2002;1: Chess C. Prospective study on combination diode laser and bipolar 463 radiofrequency energies (ELOS) for the treatment of leg veins. J 464 Cosmet Laser Ther 2004;6: