Palomar LuxIR Fractional Handpiece

laser & light technology Palomar LuxIR Fractional Handpiece ROUNDTABLE & CLINICAL TRIAL PATIENT INTERVIEW By Catherine Maley, Contributing Editor Technical Introduction by Christine Dierickx, M.D. The Palomar LuxIR Fractional Handpiece is a non-coherent infrared light source which produces light pulses in the 850-1350 nm range of spectrum. This range allows deep penetration of light into the dermis, where a controlled area of elevated temperature is created. This infrared deep heating technology has been shown to trigger a biological response which leads to collagen remodeling in the deep dermis. Remodeled collagen can smooth out fine wrinkles and tighten sagging skin. Deep heating with infrared light can also stimulate increased collagen production to create visible long-term results. The LuxIR s infrared light is delivered through a 12 x 28 mm spot size, masked to create a regular array of 21 small (3 mm diameter) beams. These beams penetrate from 1.5 to 3 mm within the deep dermis. This method creates a lattice of treated areas surrounded by largely untreated areas. This is a much safer method of treatment because the treated areas do not cause bulk damage of the surrounding tissue; and the untreated surrounding tissue provides a quicker remodeling process, with little to no downtime. It also allows more energy to be strategically delivered to the dermis without compromising the skin. SAFETY FEATURES The LuxIR has several additional safety features, including a Contact Sensor attached to the handpiece tip which will not allow pulsing until the handpiece window is in full contact with the skin. Once in contact, the LuxIR delivers 3-Stage Contact Treatment [with LuxIR] is much more gentle on the skin and comfortable for the patient compared to similar technologies. Cooling before, during, and after each pulse with the handpiece tip cooled down to 5º C. The LuxIR, therefore, offers superior skin protection and comfort. My experience with the LuxIR has been very positive. The initial clinical results look very promising, and the treatment is much more gentle on the skin and comfortable for the patient compared to similar technologies. jan. feb 2006 www.aesthetictrends.com 25

ROUNDTABLE The following is a Roundtable How is this different from previous methods of deep heating? Discussion with Drs. Dierickx, Narurkar, and Weiss. All three are highly trained and respected physicians for their advancements in laser and light medicine and have agreed to share their experiences with the Palomar LuxIR. Dierickx This method creates a lattice of treated areas surrounded by largely untreated areas. This is a much safer method of treatment because the treated areas do not cause bulk damage of the surrounding tissue, and the untreated surrounding tissue provides a quicker remodeling process. Christine Dierickx, M.D. Vic A. Narurkar, M.D. Robert A. Weiss, M.D. sapphire to cool the skin. This method of cooling was first used by Palomar in their hair removal products such as the diode laser, and most recently the StarLux, making it the safest laser/light system. The cooling in the LuxIR takes epidermal cooling even further, as these high energies require optimal epidermal protection. Systems which do not utilize this patented cooling can produce significant complications such as permanent scars, which we have seen in our practice. one time. The difference with the LuxIR is that now you can address dozens of spots which add up to one large spot so you can treat a much larger area by working in rows and covering the same amount of space in a fraction of the time. The LuxIR also has the most advanced cooling system with built-in sapphire crystal so the patient now feels slight warmth versus intense heat so they have a more positive experience. Narurkar Fractional IR is a much safer way to deliver the infrared energy as opposed to other technologies which bulk heat the dermis and are, therefore, amenable to more complications. Fractional dermal heating allows you to taper the energy based on the desired result. For example, superficial rhytids will require less heating than deep rhytids; and thinner areas of the skin will require less heating than thicker areas. The biggest advantage of the LuxIR is the most sophisticated form of epidermal cooling, which has been the hallmark of the StarLux. It uses thick Weiss Other technologies have a maximum spot size of six millimeters which is the size of a head of a pencil. So, if you have to covert the entire base, it takes a long time. Another technology addresses only one spot at LuxIR Fractional Handpiece How do you ensure skin safety when delivering pulses of deep heat? Dierickx The LuxIR has a Contact Sensor attached to the handpiece tip, which will not allow pulsing until the handpiece window is in full contact with the skin. Once in contact, the LuxIR delivers 3-Stage Contact Cooling before, during, and after each pulse with the handpiece tip cooled down to 5º C. The LuxIR, therefore, offers superior skin protection and comfort. (Continued on page 28) 26 jan. feb 2006 www.aesthetictrends.com

Outstanding clinical results in skin regeneration Portrait PSR 3 yields dramatic results through a unique thermal profile. New Portrait PSR 3 technology is clinically proven to reduce wrinkles, improve skin tone and texture, and tighten lax facial skin. Portrait PSR 3 initiates skin regeneration by delivering millisecond pulses of nitrogen plasma to the skin s surface. The rapid energy transmission is uniform, not chromophore dependent, and predictable. The presence of inert nitrogen creates a surface microenvironment that eliminates char formation. The stratum corneum and epidermal layers remain intact. This unique tissue response acts as an insulator during treatment and then provides a unique biological dressing which supports the natural healing process of skin regeneration. The net e ect is a wound response of the skin architecture without creating a wound a response completely di erent from that seen with light-based treatments or ablative lasers. Clinical studies show regeneration of the reticular architecture of the upper dermis using either single high-energy or repeat low-energy treatments. 1 A line of cleavage quickly forms after treatment. At high-energy settings the epidermis and upper dermis are shed and at low-energy settings the top 5 6 cells of the stratum corneum are shed. Below the line of cleavage the upper layer of tissue is thermally modified and is progressively replaced by a new skin architecture. Neovascularization occurs and fibroblasts from the deeper dermis migrate to restore the skin to healthier function and appearance. Ongoing matrix-like neocollagenesis further supports demonstrative and ongoing wrinkle improvement. 1 Year Histology Day 0: Pre-treatment showing solar elastosis (blue/black) with a narrow, well-marked collagen band (red) at the flattened DE junction (Grenz zone). There have been no reports of scarring or hypopigmentation in clinical studies to date. Experimental evidence indicates that pulse-stacking does not cause the morbidity associated with other treatments. Portrait PSR 3 is a versatile and safe technology. From superficial epidermal to deeper dermal treatment, Portrait PSR 3 yields the therapeutic results patients and physicians desire with an optimized recovery profile. Long-term clinical studies show a continuing regenerative process producing sustainable improvements up to a year following treatment (see clinical histological evidence at right). Patient benefits reinforce advantages of new Portrait PSR 3 skin regeneration technology. In as little as 15 30 minutes for a full-face treatment (less for regional treatment), sustainable therapeutic results can be achieved with shorter recovery time. In addition to measurable rhytide reduction, improved skin elasticity, texture, and tightening, the benefits of Portrait PSR 3 include minimal erythema, quick healing, little patient discomfort, and high patient acceptance. 2 3 Months: 30% reduction of the depth of elastosis with a widening of the collagen band at the DE junction as new collagen is laid down. Portrait PSR 3 Representative Results 1 Year: Continued marked reduction in elastosis; further neocollagenesis at the DE junction with a healthier undulating appearance. Learn more at www.rhytec.com Before 6 weeks post-treatment 4 months post-treatment Visit us at AACS Booth 515 and AAD Booth 1141 FDA-cleared for treatment of facial rhytides, superficial skin lesions, and actinic keratosis. 1. Harrison R, Ramsden A, Penny K,Wilson H, Andrews P, Gault D. Plasma Skin Resurfacing (PSR) A Preliminary Report of a New Technique for Skin Resurfacing. Lasers in Surgery and Medicine, (suppl 15): 2003. 2. Kilmer S, Semchyshyn N, Shah G, Fitzpatrick R, Lee S, Rokhsar C, Bernstein E. Pilot Study on the Use of a Plasma Skin Regeneration Device (PSR) in Full Facial Rejuvenation Procedures. Presented at ASDS meeting, San Diego, 9/2004. 2006 Rhytec, Inc. Portrait and Portrait PSR 3 are registered trademarks of Rhytec, Inc. True Regenerative Science is a trademark of Rhytec, Inc. All rights reserved. 164998 ATT Jan 06 jan

(Continued from page 26) Narurkar Fractional LuxIR surpasses the safety of previous systems, and the sophisticated cooling makes the treatment much more comfortable for the patient. We have not had the need to use any anesthetics for treatments thus far. Weiss We are able to maintain very constant skin cooling, and the handpiece is designed so it will not fire until there is perfect contact with the skin. It has virtually eliminated any fear of problems such as burning and blistering. Contact sensing is important since it prevents burning of the skin. Fractional delivery of the light improves safety and efficacy due to the lateral spread of heat. Are there other uses for this technology beyond skin tightening and collagen stimulation? LuxIR Lattice of affected areas within the dermis practice for non-invasive tissue tightening such as the jawline, neck, abdomen, arms, and knees. It is FDA cleared for deep tissue heating, and our indications are off-label. The benefit of the LuxIR technology is for patients who are looking for a nonsurgical method for tissue tightening and for a nice addition to StarLux photorejuvenation for enhanced rejuvenation with combination therapy. Weiss We are hoping we will also see textural changes, but it is too early to tell. And we are seeing much potential for active acne as well as acne scarring. We are experimenting with flabbiness on arms and have seen some improvement. The LuxIR addresses the crepiness and a little bit of the fat and excess skin that is noticeable when you hold your arm out. I ve actually tried it on family members but the results are not in yet. Also, we will try abdominal tightening soon. Who is a good candidate for LuxIR skin tightening? DierIckx Really anyone with lax skin in the face, abdomen, or arms. LuxIR treatment won t eradicate wrinkles altogether, but it shows promise to firm up the skin through collagen stimulation. Narurkar The LuxIR is indicated for patients who are seeking a non-surgical approach to tissue Dierickx The collagen stimulation effect has shown promise with skin tightening and may help with skin resurfacing, so there could be further applications for future StarLux handpieces. We ll continue to learn more through clinical trials. Narurkar The LuxIR handpiece is being used in our Female patient s abodomen treated with the LuxIR before (left) and 6 weeks after (right) third treatment. 28 jan. feb 2006 www.aesthetictrends.com

the bottom half of the face - especially the jowls. We also use a computerized device, typically used in research, which measures how easily the skin is stretched or if skin gets tighter and it gets more difficult to suction. Thus, it measures if the skin is really getting tighter versus just looking tighter. I do believe, however, it will take a series of treatments before you can see and expect a WOW result. Again, it is too soon to tell, but we are encouraged with the early results. LuxIR Treatment Vertical cross section (top) and hortizontal cross section (bottom) illustrating the affected areas within the dermis tightening. The best areas are the lower third of the face, the neck, abdomen, and knees. I also use it in combination with photofacials where the StarLux photofacial addresses the facial canvas while LuxIR addresses texture and redundancy. Weiss A good candidate for LuxIR is anyone who is noticing sagging around the jowl area and those who have some excess skin under the chin but not too excessive. Just mild sagging, because someone who needs a facelift still needs a facelift. Also, those who have that sun-damaged, leather-looking skin can benefit greatly from this treatment. What kinds of results are you seeing, and how do they differ from other technologies you ve worked with? How are you measuring results? Dierickx I have found good results with my initial clinical trials observable tightening of the abdomen and jowl area. Narurkar We are seeing nice results for tissue tightening, and a multi-center formal study is underway to document these changes. The measurement of collagen and elastin is being performed through histologic and electron micrographic studies. Weiss We are seeing results and some immediate changes in the skin, but we are not sure if that is actually tightening or edema (swelling). We have been using the LuxIR for six weeks and are seeing some improvement in those patients who have returned after four weeks. To measure results, we use up-todate photographic equipment and take very accurate pictures and position the patients identically, and we are definitely seeing visual tightening on How are the patients tolerating the treatments compared to other devices? How much discomfort is involved? Dierickx The patients reactions have been very positive, since the treatments have been quite comfortable. Since the handpiece is cooled all during treatment, it keeps the epidermis protected and the pulses mild. Narurkar The pain factor has been minimal to nonexistent. We have not had to use topicals and/or medications to prevent pain and have high patient satisfaction. Weiss We adjust the energy until the patient feels just some warmth. Then we do two to three passes over areas to tighten; and, if a particular area gets too hot, we turn down the energy. It is very tolerable so we have not had to use topicals or nerve blocks. I even tried it on my own face, and it was quite bearable. jan. feb 2006 www.aesthetictrends.com 29

spotlight ESBA Laboratories Inc. www.topicaine.com ESBA Laboratories Inc. offers TOPICAINE, topical anesthetic containing lidocaine 4% in a microemulsion gel with skin permeation enhancers and soothing agents. Fast onset of action and good efficacy proven in doubleblind, placebo-controlled independent clinical studies, where it showed better pain control than other leading brands. Reprints of studies are available upon request. Clear, non-oily gel; not conspicuous when applied, and easy to clean up. A 5% concentration is available, with labeling indication for anorectal use. Available in 3 convenient sizes, all packaged in childresistant containers. Sold wholesale to physicians and esthetic professionals, it is an excellent product to dispense from the office, improving comfort and saving both time and money for your patient and staff. No prescription required. It can be ordered directly from the manufacturer, with free shipping for orders over $100. ESBA Laboratories Inc. 800-677-9299 www.topicaine.com How are you positioning LuxIR in your practice, especially given there are so many other technologies you are already using for skin rejuvenation? DierIckx I am positioning it for the face and abdomen principally. I would not recommend it to anyone whose skin was so lax that a facelift might be desired. Narurkar We are positioning the Lux IR as follows in conjunction with StarLux photorejuvenation for lower third face tightening; in conjunction with Botox Cosmetic and fillers for enhanced rejuvenation; and as a stand-alone modality for tissue tightening for the lower third of the face, abdomen, neck, and arms. It is NOT a substitute for candidates who would otherwise require more LuxIR prior to treatment LuxIR placement on the skin s surface LuxIR sending fractional infrared pulses deep into the dermis aggressive modalities such as resurfacing or surgery. Moreover, unlike some other products which have failed because they set unrealistic expectations, the LuxIR has been developed with precision to address these issues. Until the LuxIR, we did not offer these types of procedures to our patients because we were concerned about the relative lack of efficiency with risks. With LuxIR, the safety margin has been improved considerably. We are excited to introduce the LuxIR to our patients. We find that combination therapy is truly the best approach for non-surgical or nonablative rejuvenation. A combination of StarLux photofacials, LuxIR tightening, Botox Cosmetic, and semi-permanent fillers can achieve wonderful results and very satisfied patients. Femal face before (left) and 4 months after (right) one treatment with the LuxIR. (Continued on page 32) 30 jan. feb 2006 www.aesthetictrends.com

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(Continued from page 30) Weiss We position the LuxIR for tightening versus surface textural changes you get from IPL treatments. So, if the patient has sagging skin and textural issues, we might do three to five IPL treatments for broken blood vessels, etc. But, if their concerns are sagging skin, we go to the LuxIR. We also use GentleWaves after every laser or pulsed light treatment to enhance the outcome. We are looking forward to using the LuxIR to help those patients who need a quick fix; and even though they may not get a ton of improvement in a single treatment, it will be a short appointment and they can come back again. Since no oral medications are taken, they can go about their day so this new modality fits in nicely with their schedule. Also, the StarLux platform has so many different options available that it is super versatile, so by adding the IR handpiece, we now have the ability to actually offer skin contraction. LuxIR CLINICAL TRIALS PATIENT INTERVIEW Iam a true believer in looking as good as you feel. For years, this patient had turned back the clock using the miracles of Botox, wrinkle fillers and laser therapies. While this 45-yearold patient was not yet ready for a facelift, she was searching for a safe alternative to facial rejuvenation, even though she could not expect the same dramatic results that she would get from surgery. I have tried other skin-tightening devices and would love to say they worked, but they didn t, said the patient. And she said they were painful and expensive. She also questioned their safety since she had seen other patient photos with adverse reactions such as indentations and scarring. She was a patient accustomed to visiting her dermatologist s office regularly to fine tune and maintain a youthful appearance. She was also a savvy consumer and up-to-date on the technology. I was so happy and satisfied with the results from the Palomar s StarLux, not to mention its comfort and safety, that I enthusiastically agreed to participate in the skin-tightening trials. I agreed to having my neck and knees treated with Palomar LuxIR. This patient was pleasantly surprised that Palomar s skin-tightening The Palomar LuxIR Clinical Roundtable interview was conducted by Aesthetic Trends Contributing Editor Catherine Maley, M.B.A. Ms. Maley s expertise in research of unique manufacturers products and continued timely reporting has allowed us to offer our readers an in-depth look at several products and services to help grow the cosmetic/aesthetic practice. You may reach Catherine via email at: catherine.maley@aesthetictrends.com. handpiece was easy to tolerate, comfortable, and fast. Minimal heat was felt by the patient at certain points under her chin and neck. She felt absolutely no discomfort on her knees I had some redness immediately afterwards but nothing that kept me from my regular activities, said the LuxIR trials patient. Interestingly enough, I had my regular facial a couple of days afterwards, and my esthetician commented on my tighter skin so now I am anxiously awaiting even more visible results to come. 32 jan. feb 2006 www.aesthetictrends.com