Autumn 2007 Alma Accent XL Cleared for Face and Body Wrinkles By Lara G. Owens, Contributing Editor Alma Lasers’ (Ceasarea, Israel), Accent XL radiofrequency (RF) device provides both unipolar and bi-polar treatment options for all skin types. FDA clearance was received in May for the treatment of wrinkles and rhytides. According to Macrene Alexiades-Armenakas, M.D., Ph.D., assistant clinical professor, Yale University School of Medicine (New Haven, Connecticut, U.S.) and director of Dermatology and Laser Surgery (New York City, New York, U.S.), the combination of unipolar and bi-polar RF capabilities in a single unit is a significant technological advance. “The Accent XL’s unipolar RF energy peneMacrene Alexiades-Armenakas, trates up to 20 mm, whereM.D., Ph.D. as the bi-polar energy is Assistant Clinical Professor Yale University School of Medicine more superficial, penetratNew Haven, CT, USA ing two to four millimeters,” she noted. “Unipolar energy may be used to treat body cellulite and laxity, whereas the combination of unipolar and bi-polar energy is theoretically more suitable for facial and neck rhytides.” The treatment of cellulite with the Accent XL is currently an off-label use in the United States. Accent XL offers two advantages over existing RF technologies. As director of her dermatology and research clinic, Dr. AlexiadesArmenakas has treated hundreds of patients with the Accent XL device. “Unipolar RF is electromagnetic radiation, not current, so it does not require a grounding pad like the monopolar RF technology in other RF systems,” she explained. “Another advantage is painless treatment. Stationary treatment with a monopolar RF device is painful, whereas mobile delivery with either of the Accent XL’s handpieces heats the skin gradually and does not stimulate a pain sensation.” According to Dr. Alexiades-Armenakas, the Accent XL’s unipolar and bi-polar energy are purported to work through movement stimulation of either water molecules or charged particles in the tissue, respectively, which in turn generates heat. Both stimulate the deep layers of skin by volumetric heating, which means that three-dimensional volumes — rather than only specific structures — are heated uniformly. “According to Ohm’s law, the amount of energy delivered is determined in part by the product of the current and impedance (resistance to current flow) over time,” she explained. “The resistance of charged particles throughout the tissue generates heat in a volume of tissue, so heating occurs throughout the dermis, including the deep dermis.” With the Accent XL’s volumetric heating, temperature of the tissue increases with depth of energy penetration due to superficial cooling of the epidermis through the handpiece. “The immediate thermal effects are collagen contraction in the dermis down to the subcutaneous fat and neocollagenesis,” Dr. Alexiades-Armenakas said. “Theoretically, by treating the dermal-subcutaneous junction, the connective tissue structure is stimulated through collagen contracture and neocollagenesis, thus preventing the herniation of fat into the dermis. This theoretically reduces both the production of new cellulite and the dimpling associated with existing cellulite. Laxity is also reduced presumably as the collagen contracts. More research studies are needed to elucidate the precise mechanism of tissue tightening and the durability of this effect.” Dr. Alexiades-Armenakas emphasized that proper movement of the handpiece is essential to achieving uniform volumetric heating. “Hot spots may occur if one fails to move the handpiece evenly over the treatment area, and it is desirable that contraction due to heating be uniform,” she said. “A handheld infrared thermometer shows whether one has reached the target temperature uniformly across the treatment area. Keep in mind that because the temperature of the tissue increases with depth of energy penetration, subcutaneous temperatures will be higher.” Medical Insight, Inc.® • 120 Vantis #470, Aliso Viejo, CA 92656, USA • +1 949 830 5409 • Facsimile: +1 949 830 8944 • www.euroabg.com clinical roundtable | Accent XL Editor’s Note: In the following clinical roundtable discussion, seven physicians share their knowledge and experience with the Accent XL RF platform. This discussion was moderated by dermatologist, Dr. Alexiades-Armenakas. What conditions do you treat with the Accent XL on and off label? Flor A. Mayoral, M.D. Director Mayoral Dermatology South Miami, FL, USA Greg Keller, M.D. Facial Plastic Surgeon Private Practice Santa Barbara and Los Angeles, CA, USA Martin Braun, M.D. Medical Director of Cosmetic Rejuvenation Vancouver Laser and Skin Care Center Vancouver, BC, Canada Victoria Cirillo-Hyland, M.D. Medical Director Cirillo Cosmetic Dermatology Spa Managing Partner Bryn Mawr Skin & Cancer Institute Rosemont, PA, USA David H. McDaniel, M.D. Laser Center of Virginia Virginia Beach, VA, USA David J. Goldberg, M.D. Clinical Professor of Dermatology Mount Sinai School of Medicine New York, NY, USA J.D. McCoy, N.M.D. Contour Medical Gilbert, AZ, USA 2 European Aesthetic Buyers Guide Autumn 2007 www.euroabg.com I mostly use Accent XL to reduce cellulite on the thighs and buttocks. It also works nicely to tighten skin around the face and to treat loose skin on the abdomen. We use it for skin tightening and wrinkle reduction. Off label, we use it to reduce fat and treat cellulite. I treat skin laxity and now cellulite. We also use the Accent XL with blue light to treat cystic acne, as shown in my case study to be published in the August 2007 issue of Journal of Drugs in Dermatology. The lack of disposables makes the treatment affordable for the acne patient. We use Accent XL to tighten skin on the face, neck and arms, and to reduce fat and cellulite in the abdomen, buttocks and thighs. Our primary use for Accent XL is skin tightening on the face and neck and reducing cellulite on the legs. To a lesser degree we’re also treating loose skin above the knees, upper arms and abdomen. I’ve been using it exclusively for skin tightening on the legs, abdomen and buttocks to ultimately improve cellulite. We do skin tightening, cellulite reduction and body contouring. In some patients, body contouring means some weight loss, but generally it’s more a reduction in inches. The abdomen is the most commonly treated area, which for us also means love handles and the lower back. But we’ve been using Accent XL on all the major areas of the body. clinical roundtable | Accent XL “I like having the choice between unipolar and bi-polar RF.” What are the advantages of the Accent XL over similar treatment modalities? Consider efficacy, adverse effects, downtime, patient satisfaction and disposable costs. Dr. Mayoral: Accent XL is more powerful than similar devices, and therefore more efficacious. There is no downtime and I have seen no adverse effects. It’s not even painful. I’ve actually had patients fall asleep during treatment. Dr. Braun: Accent XL ensures faster treatment times. Other RF devices are slow on large body areas and disposables often make treatments cost prohibitive. Also, since we use discomfort as an indicator that we should reduce the energy, treatment is far more comfortable than competing devices and no analgesics are required. Dr. Keller: We get superior tightening and wrinkle reduction with Accent XL compared to laser heating or other RF devices. It’s also more effective for reducing cellulite and fat. There is no downtime, which is wonderful, and it’s truly hard to hurt anyone with the Accent XL. Dr. Goldberg: Patients can come in every two weeks rather than twice a week, and receive half as many treatments as they would with other modalities. Results last longer, and there is no downtime, no disposables and minimal discomfort. The skin may look pink for a few hours, but that’s it. Before Tx Dr. McDaniel: I like having the choice between unipolar and bi-polar RF. Treatment with traditional RF devices can get hot and uncomfortable on the face, but much less so with the Accent XL system. Also, I have a high percentage of happy patients with the Accent XL. Dr. Cirillo-Hyland: I can use the unipolar handpiece to treat deeper fat on the stomach, buttocks and thighs, and the bi-polar handpiece to treat superficial fat. Dr. McCoy: The thing that’s consistently impressive is predictability. All of our patients get results with the Accent XL. The only adverse effects we see are in some of our obese patients, who notice gastrointestinal changes. Describe treatment in terms of speed, number of treatments required to achieve results and the optimal interval between treatments. Dr. Cirillo-Hyland: Four or five treatments are needed for the face, but everyone’s different. The entire face can be done in 30 to 40 minutes. For the body, we strive for six to ten treatments. Initially the interval was every two weeks, but three or four week intervals allow more time for the body to make collagen and lose fat. Body treatments generally take less than one hour, but treatment time depends on how much area you’re covering. Dr. Mayoral: It takes 15 to 20 minutes per treatment, depending on the area. For the body, we’ve been treating about six times every two weeks. One woman decided to do six more and saw a three inch reduction in her waist. So instead of six treatments for the body, a more realistic number might be ten. After three Accent XL treatments Photos courtesy of Victoria Cirillo-Hyland, M.D. Dr. Goldberg: We use about 140 to 150 watts of power, 30 second intervals and three or four passes. That takes 15 or 20 minutes. You can correlate the pink color to the right temperature. A temperature of roughly 40° to 41° C is our endpoint. Generally we do anywhere European Aesthetic Buyers Guide Autumn 2007 www.euroabg.com 3 clinical roundtable | Accent XL “Accent XL is extremely simple. There isn’t much of a learning curve, so it’s definitely a procedure you can delegate.” from six to eight treatments in two week intervals, and patients begin to notice results after the second or third treatment. Dr. McDaniel: A lot of our patients get three treatments. We’re probably not seeing results as dramatic as those with six treatments, but three treatments makes it simple and has a good value. Photographs of our patients show that improvement continues for six to nine months. Dr. Keller: Patients usually require three to five sessions, which usually take less than an hour unless we’re treating a whole body. The face takes 20 or 30 minutes. Dr. McCoy: It takes approximately 30 minutes to treat one area. Most patients receive treatments every two weeks and each area receives three to six treatments. The majority notice a difference after their first treatment, while for others improvement may require two or three sessions. Before Tx How do pre- and post treatment care and ease of use with Accent XL compare to other treatment modalities? Dr. Cirillo-Hyland: There’s a learning curve, but Accent XL is quicker and easier to use than other devices. I’ll use anesthesia upon request, as long as I can keep measuring the temperature because if they can’t feel pain, there’s potential for burning. After treatment we tell patients to avoid the sun, but that’s basically it. Dr. Mayoral: Accent XL is extremely simple. There isn’t much of a learning curve, so it’s definitely a procedure you can delegate. Dr. McDaniel: We just use baby oil on the skin and nothing after treatment. Most patients are a little red when they leave, but that disappears quickly. We’ve seen swelling, but it was mild compared to what we see with similar devices. Dr. Goldberg: It takes awhile to get used to the rotating motion, but it’s simple. We put some baby oil on the skin which makes the handpiece glide. Dr. McCoy: Patients are quite comfortable during treatment. There is no need for ice or any anesthesia. Physicians will find their own technique, but the learning curve is not steep. After four Accent XL treatments IN-Motion™ involves unique technology and the process of always moving the handpiece to ensure even heating and lower the risk of injury. How do you feel about this statement? Dr. McDaniel: My initial concern was being able to avoid hot spots, but the IN-Motion technique gives me artistic freedom and has turned out to be a real plus. Photos courtesy of Victoria Cirillo-Hyland, M.D. Dr. Keller: I will have to agree with that statement. It’s really an easy and safe technique. That’s the core of the treatment and we love it. Dr. Braun: The unipolar head heats up the body area far more quickly and deeply than any other RF technology I have worked with. Dr. Goldberg: If you’re not moving around quickly enough, the patient will tell you that the skin is getting hot. 4 European Aesthetic Buyers Guide Autumn 2007 www.euroabg.com clinical roundtable | Accent XL “Patients can expect nice tightening around the jowl, jaw line and submental area.” Dr. McCoy: The IN-Motion technology gives the user a significant amount of control. The only potential for a complication comes from not moving the device during treatment. Patients let you know when they’re too hot, so you either stop or move to another area to be treated. How does the Accent XL compare with other treatment modalities regarding pain during treatment? Dr. Braun: We use pain as our guide. If treatment is painful, we turn down the energy. You can’t do that with other RF devices. Dr. McDaniel: No one has complained about the bi-polar treatment being uncomfortable. Some say it feels like a massage. If you are in an area too long with the unipolar handpiece, the sensation can quickly go from warm to very hot, which can get uncomfortable. You get into a rhythm, though, which just takes experience. Dr. Goldberg: It’s a very comfortable procedure for the patient as long as you are constantly in motion. We ask patients to rate the discomfort on a one to five scale, one being comfortable and five being incredibly painful. We want to get to a level of about three. Before Tx Dr. Cirillo-Hyland: You have to move the handpiece fairly quickly. People can feel discomfort if you stay in one spot too long. Intense pulsed light (IPL) hurts more than Accent XL, and so do fillers and lasers. On the body, patients say Accent XL feels like a warm massage. Dr. Mayoral: If the patient tells you an area is getting warm, avoid that area or take your finger off the trigger and move on. You can sometimes see the redness on the skin surface, so simply check the temperature. Dr. Keller: Pain with Accent XL is definitely less than with other devices. You want to raise the temperature of the skin and pass over it at that temperature. If you get hot spots, pass over them more quickly. We don’t use anesthesia. Dr. McCoy: Accent XL is less painful than most other treatment modalities. Most patients rate discomfort at two or three on a scale of one to ten. They say it feels like they just jumped into a hot tub. The heat is intense, but the area cools as soon as you stop treatment, so there is no extended discomfort. How do you manage the expectations of patients? What results can they expect? Dr. Goldberg: Since we’re treating mostly cellulite, it’s easy to manage expectations. Most of these people have already tried many modalities and been disappointed, so their expectations are already low. With Accent XL, they’ll see an improvement of up to an inch in thigh circumference. Dr. Keller: We counsel that Accent XL is not a face-lift. Patients can expect nice tightening around the jowl, jaw line and submental area. In the body, they’ll likely see diminishment of their cellulite and slight diminishment of the circumference of their extremities. After Accent XL Tx Photos courtesy of David H. McDaniel, M.D. Dr. Braun: We are now trying an “Accent XL Club” approach. The patient buys a 15 minute or 30 minute appointment once a week for six months or a year. Theoretically, they could treat their thighs until they’re satisfied then move on. This way, the patient is in control. European Aesthetic Buyers Guide Autumn 2007 www.euroabg.com 5 clinical roundtable | Accent XL “From my experience, people coming back at the quarter are still happy with results, especially on the face and neck.” Dr. Mayoral: I tell them that with any other procedure, some respond early and dramatically and others see a more moderate change. They should undergo the recommended treatments and give it a chance. Dr. Cirillo-Hyland: I tell them that everyone will get a result with Accent XL. The question is how much. If a woman comes in with excessively loose skin on her neck, she probably needs surgery. Dr. McCoy: We show photographs taken before and after treatment and explain that results can vary. What’s interesting is that often, the more wrinkled and textured a person is, the better the result. Patients with lumpier fat deposits also see significantly smoother skin after Accent XL treatment. Please comment on patient satisfaction and convenience with the Accent XL. Dr. Braun: Satisfaction rates are far superior with Accent XL than with many other modalities. Before Tx Dr. Goldberg: They’re gratified because results are clearly better with Accent XL than with anything else they’ve tried. Fewer treatments are needed and the results are longer lasting. Dr. Keller: Patients seem to be as satisfied with Accent XL as any other modality that we use. I think one of the keys to satisfaction is coming up with objective information and that’s what we’re in the process of doing. Dr. Mayoral: Some patients see results after the first or second treatment. Those patients are ecstatic and tell their friends. Dr. McCoy: We have about 40 visits per week and our patient satisfaction is easily 90%. It’s unbelievable. What have been your long-term results with the Accent XL? Do your patients require maintenance treatments? Dr. McDaniel: We’re taking photographs every three months after treatment sessions, but we have no 12 month people yet. Maintenance treatments are likely more necessary with cellulite than with conditions of the face, but cellulite patients from last fall seem to be maintaining the benefit. After Accent XL Tx Photos courtesy of David H. McDaniel, M.D. Dr. Cirillo-Hyland: From my experience, people coming back at the quarter are still happy with results, especially on the face and neck. Sometimes body patients request one or two additional treatments. We have women coming in for their ninth and tenth treatment, and even though I think they look great, they consider it maintenance. Dr. Keller: Results seem to be holding for six to twelve months. It’s too early to tell, but we anticipate some need for maintenance treatments. Dr. Goldberg: These people are not expecting miracles. We have not yet had to perform maintenance procedures, however. We expect that in 12 to 24 months, patients will be back. Dr. Mayoral: I’ve had this device for only a year and a half, so it’s too early to tell if and when maintenance treatments will be necessary. 6 European Aesthetic Buyers Guide Autumn 2007 www.euroabg.com clinical roundtable | Accent XL “Accent XL was not difficult to integrate. It has added another dimension to my practice.” Dr. Braun: Cellulite is an ongoing, progressive problem. We tell patients to expect maintenance once they reach a satisfactory endpoint. Dr. McCoy: I’ve only had the device since June, so it’s difficult to say at this time. Have you combined the Accent XL with other treatment modalities, and if so, what benefits have your patients achieved? Dr. Mayoral: I’ve used Accent XL with IPL, Botox (Allergan, Inc., Irvine, California, U.S.) and injectable fillers. I remind patients that when you put on make-up, you don’t just put on mascara. You combine different treatments for a better final result. Dr. McDaniel: Combining Accent XL with something like Juvéderm (Allergan, Inc., Irvine, California, U.S.) gives the patient an immediate effect and then the long-term benefit of the Accent XL. We might add fractional photothermolysis treatment for patients with a lot of fine lines on their upper lip or a deep nasolabial furrow. Dr. Cirillo-Hyland: If you think of the anti-aging tree, we have many branches we can pull including Botox, fillers, rejuvenation lasers such as the Pixel (Alma Lasers) and pulsed light. I’ve used all of those with Accent XL. It’s like 360° of rejuvenation. Before Tx Dr. Goldberg: In time we’ll undoubtedly be combining Accent XL with focused ultrasound once it becomes available. Focused ultrasound works on the fat and Accent XL works on the fibrous bands. Between the two we should get a synergistic effect. Dr. Keller: We have combined Accent XL treatments with Pixel. We do Accent XL first, let everything cool down, and as long as the skin isn’t red we’ll proceed with Pixel to help get rid of brown pigment and sun damage. The overall effect is nice. Dr. Braun: Combining lipodissolve injections with Accent XL offers better results because the skin has time to retract and there are no undulating rolls, as is frequently seen with liposuction. Dr. McCoy: I’ve been using Accent XL in combination with mesotherapy or lipodissolve for patients with large amounts of localized fat. The combination helps to break down the fat and enhance the overall effect. Describe how you integrated the Accent XL into your practice. Dr. Braun: We started with internal marketing, especially with our sclerotherapy and lipodissolve patients who obviously care about the appearance of their legs. Dr. Cirillo-Hyland: It wasn’t difficult to integrate. We were looking for something painless, non-invasive and flexible that could visibly tighten skin with no downtime or consumable tips. The Accent XL fit that niche well for me. It’s the only thing I use for tightening skin. After Accent XL Tx Photos courtesy of David J. Goldberg, M.D., J.D. Dr. Mayoral: Accent XL was not difficult to integrate. It has added another dimension to my practice. It’s easy to delegate, and because there’s no downtime, the procedure won’t cramp the patient’s lifestyle. Patients like that. Dr. Goldberg: Integration was a piece of cake. We see people for cellulite all the time and we just did not have good modalities of treatment before Accent XL came along. European Aesthetic Buyers Guide Autumn 2007 www.euroabg.com 7 clinical roundtable | Accent XL “We see people for cellulite all the time and we just did not have good modalities of treatment before Accent XL came along.” CONTACTS: Macrene Alexiades-Armenakas, M.D., Ph.D. Director Dermatology and Laser Surgery New York, NY, USA voice: +1 212 570 2067 email: dralexiades@nyderm.org Martin Braun, M.D. Vancouver Laser & Skin Care Centre Inc. Vancouver, BC, Canada voice: +1 604 708 9891 fax: +1 604 708 9803 email: drmbraun@vancouverlaser.com Victoria Cirillo-Hyland, M.D. Medical Director Cirillo Cosmetic Dermatology Spa Rosemont, PA, USA voice: +1 610 525 5028 email: bmscitc@netzero.com David J. Goldberg, M.D., J.D. Director Skin Laser & Surgery Specialists of NY/NJ New York, NY, USA voice: +1 212 750 8900 fax: +1 201 441 9893 email: drdavidgoldberg@drdavidgoldberg.com Greg Keller, M.D. Facial Plastic Surgeon Santa Barbara, CA, USA voice: +1 805 687 6408 fax: +1 805 563 7750 email: faclft@aol.com Flor A. Mayoral, M.D. Director Mayoral Dermatology South Miami, FL, USA voice: +1 305 665 6166 fax: +1 305 662 4649 email: info@flormayoral.com Dr. Keller: We had a hard time, but only because we had it before any parameters were set. Today it would be pretty easy because the techniques of doing it have since been defined. It’s very easy to learn. Dr. McDaniel: It took me a while to figure out what we could realistically promise and predict, but there is more data out now than when I got the Accent XL. But the technique is simple. It’s about blending it in with other treatments and learning its capabilities. Dr. McCoy: It was very easy to integrate. I recognized that the trend was moving toward less invasive ways to contour the body, so the focus of my practice for the last five years has been these kinds of aesthetic treatments. What treatment advice can you offer? Dr. Braun: Advise patients to eat healthy food and watch their weight. If patients pack on fat more quickly than I can melt it off, this treatment is a waste of time and money for them. Dr. Cirillo-Hyland: A realistic expectation is the best advice. Fat reduction is not going to work on someone who is obese or very small. It’s for your average woman, size 10 to 16, and that’s a good sized portion of the American population. Dr. McDaniel: We’ve started giving Accent XL patients light-emitting diode (LED) photomodulation which seems to help reduce post treatment redness. Recently, we’ve been retreating patients by making a 30 second pass on each side of the face with the unipolar handpiece just superior and lateral to the nasolabial furrow. This has produced fairly significant tightening. Dr. Goldberg: During treatment, be constantly in motion and make sure you get that brisk, pink skin color, otherwise you won’t get good results. Dr. Keller: Titration is very easy to do with Accent XL. Start out at the lower setting, work upward and see where your temperatures are. Dr. McCoy: Accent XL treatment is about safely delivering as much energy as possible. The longer the area being treated is at the therapeutic temperature, the more dramatic the overall result. Alma’s protocol says two minutes, which I would say is a minimum. J.D. McCoy, N.M.D. Contour Medical Gilbert, AZ, USA voice: +1 480 545 2832 email: drmccoy@contourmedical.com David H. McDaniel, M.D. Laser Center of Virginia Virginia Beach, VA, USA voice: +1 757 437 8900 8 European Aesthetic Buyers Guide Autumn 2007 www.euroabg.com