W hile it is difficult to get a clear picture of the exact size of the cellulite treatment market, some market watchers estimate that American women are spending nearly $6 billion a year trying to banish those unsightly dimples and lumps. What is clear is that the market is enormous and is likely to continue to grow dramatically in the coming years. Today, only a small percentage of women have tapped into the market products and treatment options, but as products get better and treatments become more effective, more and more woman will enter the marketplace. “Ten years ago, cellulite patients were just a tiny fraction of the patients we saw,” said Mitchel P. Goldman, M.D., Medical Director of La Jolla SpaMD and Dermatology/Cosmetic Laser Associates of La Jolla. “Today, we treat about 10 cellulite patients a day, which is about 10% of our medical spa business. We have four cellulite treatment devices at the spa, and we keep all four very busy.” There are a number of reasons likely why the cellulite market is growing; the greater interest in looking young and vital and the general increase in cosmetic procedures are just two. But perhaps the most important factor in the growth of the market is the fact the there are now treatments on the market that actually work and produce longer lasting results. “We have been treating cellulite for a long time, but it has only been very recently that we have been able to achieve significant, longer-term improvement in the appearance of cellulite,” explained Tina Alster, M.D., Director of the Washington Institute of Dermatologic Laser Surgery and Clinical Professor of Dermatology at Georgetown University. “In the early ’90s, we started using the endermologie device, which produced good results in a certain number of patients. Now we have devices, such as the VelaSmooth, that significantly improves the look of cellulite in most of the patients that we treat.” The VelaSmooth from Syneron Medical Ltd. along with the TriActive LaserDermology Cellulite Treatment System from Cynosure, Inc. are two devices on the market that combine the massage operation of the older endermologie approach with various energy sources that deliver heat and — in the case of the TriActive — low-fluence laser and cooling to the treated area. Both devices have been subject to clinical study and both have been reviewed by the FDA and approved to be marketed as devices that can temporarily reduce the appearance of cellulite. TriActive: Massage with Low-Fluence Laser and Cooling The TriActive system employs mechanical massage, localized cooling and laser stimulation to improve the appearance of cellulite. In addition to improvement in skin appearance as a result of the action of the suction massage elements of the device, the manufacturer claims that the energy from the six diode lasers enhances microcirculation. Reduced circulation is often cited as a cause of cellulite. The device also employs selective cooling that the manufacturer says is a key element in the overall effectiveness of the device. “Before we had the TriActive, there was nothing that would reliably address extensive cellulite. Initially, we were very skeptical about the device because we had been down that road before,” explained Bruce Katz, M.D., Director of the Cosmetic Surgery and Laser Clinic at Mount Sinai Hospital and Clinical Professor at the Mount Sinai School of Medicine. “We started using it about a year ago and now it is our preferred method. We use it to treat women who have extensive cellulite, involving the thighs, buttock and hips, and the results have been terrific.” To determine the effectiveness of the laser, Dr. Katz and his assistant Kathryne Frew, M.D., conducted a study involving 10 women with extensive cellulite. In the study, the women were treated on one side of the body with only the cooling and suction massage, which is comparable to endermologie. On the other side, they were treated using all three components, the suction, cooling, and laser. Each patient had 16 treatments. “We noted improvement in 83% of the patients on the side with the laser on, compared to only 17% with the laser off,” said Dr. Katz. “After 3 months, the percentage of improvement remained the same.” Dr Katz will continue to follow these patients to determine how long the effects last. In practice, the procedure is typically done in a series of 10 to15 treatments spaced as closely as three times per week, or as far apart as once a week. Normally the series can be done annually with follow-up monthly maintenance treatments. Each session lasts about 45 minutes and the procedure is relatively painless. Patients often compare it to a typical massage. Results can vary depending upon the patient, the area being treated and the age of the patient. “TriActive is not going to make all of your cellulite go away, but it significantly improves the appearance of the cellulite in the overwhelming majority of women,” Dr. Katz said. “Right now, our trained massage therapists are treating eight to 10 patients a day in our medical spa and they are almost always very happy with the results. They keep coming back for more.” Other physicians have conducted studies that showed the effectiveness of the TriActive device. “If you are going to use a device at your spa, you need to know that there is something more than hype,” commented Michael Gold, M.D., a Dermatologist in private practice in Nashville, TN. “With the TriActive, I know that I have a device that has been reviewed and clinically studied with demonstrated and published results. In our patient population virtually everyone showed dramatic improvement with the TriActive.” VelaSmooth: Massage coupled with RF and IR VelaSmooth uses bi-polar radiofrequency and infrared light along with tissue mobilization and suction to re-contour the skin surface. The manufacture claims that the combined radiofrequency with infrared light soften and rearrange fat and the suction massage stretches the fibrous strands that contribute to the dimpling. “I have been treating cellulite since the early 90s and I was very excited when the VelaSmooth was introduced,” Dr. Alster said. “We had been using endermologie, but the results with that device varied, some patients responded others didn’t. Once we tried the VelaSmooth, we were very quickly convinced that it worked better. I sold my endermologie machine and switched all my patients over to VelaSmooth. They were all were very happy. As an early adopter of the VelaSmooth, Dr. Alster conducted a study examining the effectiveness of the device. The study looked at 20 adult women who had moderate amounts of bilateral thigh and buttocks cellulite. Each patient in the study received eight treatments twice a week to one or the other thigh. The treatments lasted 30 to 45 minutes. The other thigh was untreated. The patients’ weight and leg measurements were taken prior to the start of treatment. “We took digital photographs of each patient prior to each of the eight treatment sessions and at 1, 3 and 6 months after the final treatment and the photos were evaluated by two medical assessors not involved in the treatments,” said Dr. Alster. Clinical improvement scores were made based on a quartile grading scale (0=<25% improved, 1=25% to 50% improved, 2=51% to 75% improved). Side effects were limited to mild transient erythema and bruising (the latter being observed in only two of the patients and occurred only in the first few treatment sessions). According to Dr. Alster, the average clinical improvement score was 1.82, which corresponds to about a 50% improvement. In addition, the circumferences of the treated thighs were reduced on average by 0.8 centimeters or about one third of an inch. “We looked at body weights and nobody had any significant change in body weight so this drop in the size of the treated thigh is related to the treatment,” Dr. Alster explained. “Of the patients, 18 of the 20 (90%) noticed some overall clinical improvement on the treated side. All but one of those indicated that they would pursue treatment of the contra-lateral thigh.” Follow-up showed a slight decrease in the improvement after 1 month with a nearly 50% drop after 6 months. Dr. Alster concluded that there was an additive effect to the treatments and determined that the best course of treatment is 8 sessions, twice a week for 4 weeks. “We know that when you can increase neocollagenesis, you improve the surface appearance of the skin. The heat delivery to the dermis initiates collagen remolding through controlled tissue inflammation and collagen contraction. It’s the combination of the various modalities that delivers the most impact.” The device is very comfortable for the patient, though some patients complain of a pinching sensation on the lateral aspects of the bottom of the thighs. “What I like about this treatment is that it is totally non-invasive, without needles or blood exposure. People can walk in and have this treatment, literally on their lunch hour and they can go back to work,” explained Dr. Alster. “Most patients experience clinical improvement and some even demonstrate marked improvement. It’s an easy outpatient procedure and is not super expensive.” Dr. Goldman uses a number of different treatments for his cellulite patients, including the VelaSmooth. “My staff prefers the VelaSmooth and they think it is the more effective device,” he said. “The patients like it as well as it seems to give quicker results. I can get most of my patients to between 50% and 70% improvement.” However, Dr. Goldman has found that many patients who do not respond to a particular treatment will often respond to another form of treatment. Dr. Goldman is currently conducting a study comparing the VelaSmooth to the TriActive device. Other Modalities: Endermologie, Ionithermie and Subcision Developed in France and in use since the early ’90s, endermologie was the first widely-used treatment option that employed mechanical massage to improve the appearance of cellulite. The FDA currently uses endermologie as its predicate for determining the effectiveness of other massage-based system for cellulite treatment and many physicians continue to use the device to treat cellulite patients. “We have had good results with many patients using the endermologie device and we continue to use it today on a daily basis,” said Dr. Goldman. “It is a less-expensive option and some of our patients prefer the treatment and are very happy with the results.” Another treatment option is ionithermie. With this procedure, the area to be treated is encased in a mixture of clay, algae and other botanical compounds and then wrapped. The area is stimulated with galvanic and faradic electrical impulses. “If a patient wants to look really good quickly, we use ionithermie, because that will usually take off an inch or two and smooth the skin with one treatment,” explained Dr. Goldman. “But that doesn’t last any more than a day.” If treating small areas of cellulite, some physicians use fat harvested from the patient or other body fillers. However, the viability of harvested fat is variable and the harvesting can cause problems as well. Using a filler may produce more predictable results, but if the patient loses weight the fillers can become visible under the skin. For small areas, many physicians will perform a subcision, which involves the use of a specialized needle to cut the fibrous cords causing the depression. “There are some women who have small pockets of localized cellulite and for those areas, we use subcision using a NoKor needle,” said Dr. Katz. “However, it is not an effective way to treat large areas, nor would it be desirable to do so.” Lotions, Potions and Creams Many physicians advocate the use of anti-cellulite creams as part of an overall cellulite treatment approach, though many question their effectiveness and others wonder about the pressure some physicians might put on their patients to buy these products. Dr. Gold incorporates creams into his cellulite treatment program both because he feels that they work, and also because he believes that it empowers the patients to become more involved with their treatments. “When someone says that they have a green tea extract with caffeine that has been shown to reduce cellulite, there is no question that it has.” said Dr. Gold. “We have vitamin-based therapies that incorporate caffeine that if used properly and maintain can help the appearance of cellulite. I am also a big believer in getting the patient to be an active participant in their own treatment and selling them a cream that they take home is one important way to do that.” Dr. Gold advised that at the very least, patients who use creams as an adjunct to treatment with one of the devices can increase the time between treatments. “If a patient spends $50 on a cream that helps her avoid a couple of $100 treatments, then that is cost- and time-effective,” he said. “Keep in mind that they are going to most likely go to a pharmacy and buy a cream anyway, so they might as well buy from a physician who is selling a product shown to work.” Dr Goldman also maintained that the anti-cellulite creams have a place in treatment. “A number of creams are effective in improving the appearance of cellulite. I have two peer-reviewed studies that show that the creams work,” he said. “We actually combine the creams with a bio-occlusive short that aids in the penetration of the cream into the skin.” He goes on to point out that while not as effective as the machines, published studies have shown patients can achieve a 20% to 35% improvement using the creams. What Does the FDA Have to Say? A quick search of the Internet uncovers countless Web sites claiming “an FDA-approved treatment for cellulite.” However, the FDA does not “approve” cellulite treatment devices the way in which it approves new medications. “There are no cellulite treatment devices that can claim to have FDA approval,” explained Richard Felten, Senior Reviewer and Photobiologist with the General Surgical Devices Branch of the FDA. “They can say that the FDA has granted them a 510(k) permission to market the device as a treatment to temporarily improve the appearance of cellulite. When you use the term FDA-approved, people think that the device has been scrutinized to the degree that we would look at a new drug, and that is simply not the case.” Under section 510(k) of the Food, Drug and Cosmetic Act, anyone who wants to market a new or modified medical device has to submit it to the FDA for review. The FDA only determines two things: is the device at least as effective as devices previously evaluated by the FDA for the same purpose and is the device safe. If they determine that it is both effective and safe, they grant permission to market the device for its intended purpose. “The 510(k) process allows a manufacture to go to market with a device based on a comparison of technology and a finding of equivalence in terms of safety and effectiveness of the device,” said Mr. Felten. “For the cellulite devices, we have simply compared the devices to an existing device and determined that the new devices are as effective and as safe as existing predicates without any in-depth review of clinical data.” Demand for Better Treatments will Continue Until there is a cure for cellulite, and at present there is none, women will continue to seek treatments to improve the appearance of their cellulite. As treatments for cellulite continue to improve, the clamor for even better treatments will grow louder. Patients who today are satisfied with a 50% improvement will demand even greater improvement. Manufactures are scrambling to develop these more effective techniques and physicians are lining up to evaluate new technologies and approaches. “Cellulite is the next horizon and it may be an even bigger market than anyone imaged. Every laser company is looking at what they can do differently, tweaking different IPL systems, different diode systems, using suction, using massaging, combining modality, using special cooling like the TriActive,” said Dr. Gold. “What has been developed works, but don’t be surprised if in a year or two we have three or four more devices that work even better.” Disclosures: Dr. Alster is on the Medical Advisory Board for Syneron. Dr. Gold is a stock holder and receives research grants from Cynosure, Inc. Dr. Goldman conducted a research study for Cynosure on TriActive and is doing a research study with VelaSmooth for Syneron. He also owns and developed the SpaMD anti-cellulite cream and bioceramic shorts. Dr. Katz has no relevant financial disclosures.
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Treating Cellulite: What Really Works?
W hile it is difficult to get a clear picture of the exact size of the cellulite treatment market, some market watchers estimate that American women are spending nearly $6 billion a year trying to banish those unsightly dimples and lumps. What is clear is that the market is enormous and is likely to continue to grow dramatically in the coming years. Today, only a small percentage of women have tapped into the market products and treatment options, but as products get better and treatments become more effective, more and more woman will enter the marketplace. “Ten years ago, cellulite patients were just a tiny fraction of the patients we saw,” said Mitchel P. Goldman, M.D., Medical Director of La Jolla SpaMD and Dermatology/Cosmetic Laser Associates of La Jolla. “Today, we treat about 10 cellulite patients a day, which is about 10% of our medical spa business. We have four cellulite treatment devices at the spa, and we keep all four very busy.” There are a number of reasons likely why the cellulite market is growing; the greater interest in looking young and vital and the general increase in cosmetic procedures are just two. But perhaps the most important factor in the growth of the market is the fact the there are now treatments on the market that actually work and produce longer lasting results. “We have been treating cellulite for a long time, but it has only been very recently that we have been able to achieve significant, longer-term improvement in the appearance of cellulite,” explained Tina Alster, M.D., Director of the Washington Institute of Dermatologic Laser Surgery and Clinical Professor of Dermatology at Georgetown University. “In the early ’90s, we started using the endermologie device, which produced good results in a certain number of patients. Now we have devices, such as the VelaSmooth, that significantly improves the look of cellulite in most of the patients that we treat.” The VelaSmooth from Syneron Medical Ltd. along with the TriActive LaserDermology Cellulite Treatment System from Cynosure, Inc. are two devices on the market that combine the massage operation of the older endermologie approach with various energy sources that deliver heat and — in the case of the TriActive — low-fluence laser and cooling to the treated area. Both devices have been subject to clinical study and both have been reviewed by the FDA and approved to be marketed as devices that can temporarily reduce the appearance of cellulite. TriActive: Massage with Low-Fluence Laser and Cooling The TriActive system employs mechanical massage, localized cooling and laser stimulation to improve the appearance of cellulite. In addition to improvement in skin appearance as a result of the action of the suction massage elements of the device, the manufacturer claims that the energy from the six diode lasers enhances microcirculation. Reduced circulation is often cited as a cause of cellulite. The device also employs selective cooling that the manufacturer says is a key element in the overall effectiveness of the device. “Before we had the TriActive, there was nothing that would reliably address extensive cellulite. Initially, we were very skeptical about the device because we had been down that road before,” explained Bruce Katz, M.D., Director of the Cosmetic Surgery and Laser Clinic at Mount Sinai Hospital and Clinical Professor at the Mount Sinai School of Medicine. “We started using it about a year ago and now it is our preferred method. We use it to treat women who have extensive cellulite, involving the thighs, buttock and hips, and the results have been terrific.” To determine the effectiveness of the laser, Dr. Katz and his assistant Kathryne Frew, M.D., conducted a study involving 10 women with extensive cellulite. In the study, the women were treated on one side of the body with only the cooling and suction massage, which is comparable to endermologie. On the other side, they were treated using all three components, the suction, cooling, and laser. Each patient had 16 treatments. “We noted improvement in 83% of the patients on the side with the laser on, compared to only 17% with the laser off,” said Dr. Katz. “After 3 months, the percentage of improvement remained the same.” Dr Katz will continue to follow these patients to determine how long the effects last. In practice, the procedure is typically done in a series of 10 to15 treatments spaced as closely as three times per week, or as far apart as once a week. Normally the series can be done annually with follow-up monthly maintenance treatments. Each session lasts about 45 minutes and the procedure is relatively painless. Patients often compare it to a typical massage. Results can vary depending upon the patient, the area being treated and the age of the patient. “TriActive is not going to make all of your cellulite go away, but it significantly improves the appearance of the cellulite in the overwhelming majority of women,” Dr. Katz said. “Right now, our trained massage therapists are treating eight to 10 patients a day in our medical spa and they are almost always very happy with the results. They keep coming back for more.” Other physicians have conducted studies that showed the effectiveness of the TriActive device. “If you are going to use a device at your spa, you need to know that there is something more than hype,” commented Michael Gold, M.D., a Dermatologist in private practice in Nashville, TN. “With the TriActive, I know that I have a device that has been reviewed and clinically studied with demonstrated and published results. In our patient population virtually everyone showed dramatic improvement with the TriActive.” VelaSmooth: Massage coupled with RF and IR VelaSmooth uses bi-polar radiofrequency and infrared light along with tissue mobilization and suction to re-contour the skin surface. The manufacture claims that the combined radiofrequency with infrared light soften and rearrange fat and the suction massage stretches the fibrous strands that contribute to the dimpling. “I have been treating cellulite since the early 90s and I was very excited when the VelaSmooth was introduced,” Dr. Alster said. “We had been using endermologie, but the results with that device varied, some patients responded others didn’t. Once we tried the VelaSmooth, we were very quickly convinced that it worked better. I sold my endermologie machine and switched all my patients over to VelaSmooth. They were all were very happy. As an early adopter of the VelaSmooth, Dr. Alster conducted a study examining the effectiveness of the device. The study looked at 20 adult women who had moderate amounts of bilateral thigh and buttocks cellulite. Each patient in the study received eight treatments twice a week to one or the other thigh. The treatments lasted 30 to 45 minutes. The other thigh was untreated. The patients’ weight and leg measurements were taken prior to the start of treatment. “We took digital photographs of each patient prior to each of the eight treatment sessions and at 1, 3 and 6 months after the final treatment and the photos were evaluated by two medical assessors not involved in the treatments,” said Dr. Alster. Clinical improvement scores were made based on a quartile grading scale (0=<25% improved, 1=25% to 50% improved, 2=51% to 75% improved). Side effects were limited to mild transient erythema and bruising (the latter being observed in only two of the patients and occurred only in the first few treatment sessions). According to Dr. Alster, the average clinical improvement score was 1.82, which corresponds to about a 50% improvement. In addition, the circumferences of the treated thighs were reduced on average by 0.8 centimeters or about one third of an inch. “We looked at body weights and nobody had any significant change in body weight so this drop in the size of the treated thigh is related to the treatment,” Dr. Alster explained. “Of the patients, 18 of the 20 (90%) noticed some overall clinical improvement on the treated side. All but one of those indicated that they would pursue treatment of the contra-lateral thigh.” Follow-up showed a slight decrease in the improvement after 1 month with a nearly 50% drop after 6 months. Dr. Alster concluded that there was an additive effect to the treatments and determined that the best course of treatment is 8 sessions, twice a week for 4 weeks. “We know that when you can increase neocollagenesis, you improve the surface appearance of the skin. The heat delivery to the dermis initiates collagen remolding through controlled tissue inflammation and collagen contraction. It’s the combination of the various modalities that delivers the most impact.” The device is very comfortable for the patient, though some patients complain of a pinching sensation on the lateral aspects of the bottom of the thighs. “What I like about this treatment is that it is totally non-invasive, without needles or blood exposure. People can walk in and have this treatment, literally on their lunch hour and they can go back to work,” explained Dr. Alster. “Most patients experience clinical improvement and some even demonstrate marked improvement. It’s an easy outpatient procedure and is not super expensive.” Dr. Goldman uses a number of different treatments for his cellulite patients, including the VelaSmooth. “My staff prefers the VelaSmooth and they think it is the more effective device,” he said. “The patients like it as well as it seems to give quicker results. I can get most of my patients to between 50% and 70% improvement.” However, Dr. Goldman has found that many patients who do not respond to a particular treatment will often respond to another form of treatment. Dr. Goldman is currently conducting a study comparing the VelaSmooth to the TriActive device. Other Modalities: Endermologie, Ionithermie and Subcision Developed in France and in use since the early ’90s, endermologie was the first widely-used treatment option that employed mechanical massage to improve the appearance of cellulite. The FDA currently uses endermologie as its predicate for determining the effectiveness of other massage-based system for cellulite treatment and many physicians continue to use the device to treat cellulite patients. “We have had good results with many patients using the endermologie device and we continue to use it today on a daily basis,” said Dr. Goldman. “It is a less-expensive option and some of our patients prefer the treatment and are very happy with the results.” Another treatment option is ionithermie. With this procedure, the area to be treated is encased in a mixture of clay, algae and other botanical compounds and then wrapped. The area is stimulated with galvanic and faradic electrical impulses. “If a patient wants to look really good quickly, we use ionithermie, because that will usually take off an inch or two and smooth the skin with one treatment,” explained Dr. Goldman. “But that doesn’t last any more than a day.” If treating small areas of cellulite, some physicians use fat harvested from the patient or other body fillers. However, the viability of harvested fat is variable and the harvesting can cause problems as well. Using a filler may produce more predictable results, but if the patient loses weight the fillers can become visible under the skin. For small areas, many physicians will perform a subcision, which involves the use of a specialized needle to cut the fibrous cords causing the depression. “There are some women who have small pockets of localized cellulite and for those areas, we use subcision using a NoKor needle,” said Dr. Katz. “However, it is not an effective way to treat large areas, nor would it be desirable to do so.” Lotions, Potions and Creams Many physicians advocate the use of anti-cellulite creams as part of an overall cellulite treatment approach, though many question their effectiveness and others wonder about the pressure some physicians might put on their patients to buy these products. Dr. Gold incorporates creams into his cellulite treatment program both because he feels that they work, and also because he believes that it empowers the patients to become more involved with their treatments. “When someone says that they have a green tea extract with caffeine that has been shown to reduce cellulite, there is no question that it has.” said Dr. Gold. “We have vitamin-based therapies that incorporate caffeine that if used properly and maintain can help the appearance of cellulite. I am also a big believer in getting the patient to be an active participant in their own treatment and selling them a cream that they take home is one important way to do that.” Dr. Gold advised that at the very least, patients who use creams as an adjunct to treatment with one of the devices can increase the time between treatments. “If a patient spends $50 on a cream that helps her avoid a couple of $100 treatments, then that is cost- and time-effective,” he said. “Keep in mind that they are going to most likely go to a pharmacy and buy a cream anyway, so they might as well buy from a physician who is selling a product shown to work.” Dr Goldman also maintained that the anti-cellulite creams have a place in treatment. “A number of creams are effective in improving the appearance of cellulite. I have two peer-reviewed studies that show that the creams work,” he said. “We actually combine the creams with a bio-occlusive short that aids in the penetration of the cream into the skin.” He goes on to point out that while not as effective as the machines, published studies have shown patients can achieve a 20% to 35% improvement using the creams. What Does the FDA Have to Say? A quick search of the Internet uncovers countless Web sites claiming “an FDA-approved treatment for cellulite.” However, the FDA does not “approve” cellulite treatment devices the way in which it approves new medications. “There are no cellulite treatment devices that can claim to have FDA approval,” explained Richard Felten, Senior Reviewer and Photobiologist with the General Surgical Devices Branch of the FDA. “They can say that the FDA has granted them a 510(k) permission to market the device as a treatment to temporarily improve the appearance of cellulite. When you use the term FDA-approved, people think that the device has been scrutinized to the degree that we would look at a new drug, and that is simply not the case.” Under section 510(k) of the Food, Drug and Cosmetic Act, anyone who wants to market a new or modified medical device has to submit it to the FDA for review. The FDA only determines two things: is the device at least as effective as devices previously evaluated by the FDA for the same purpose and is the device safe. If they determine that it is both effective and safe, they grant permission to market the device for its intended purpose. “The 510(k) process allows a manufacture to go to market with a device based on a comparison of technology and a finding of equivalence in terms of safety and effectiveness of the device,” said Mr. Felten. “For the cellulite devices, we have simply compared the devices to an existing device and determined that the new devices are as effective and as safe as existing predicates without any in-depth review of clinical data.” Demand for Better Treatments will Continue Until there is a cure for cellulite, and at present there is none, women will continue to seek treatments to improve the appearance of their cellulite. As treatments for cellulite continue to improve, the clamor for even better treatments will grow louder. Patients who today are satisfied with a 50% improvement will demand even greater improvement. Manufactures are scrambling to develop these more effective techniques and physicians are lining up to evaluate new technologies and approaches. “Cellulite is the next horizon and it may be an even bigger market than anyone imaged. Every laser company is looking at what they can do differently, tweaking different IPL systems, different diode systems, using suction, using massaging, combining modality, using special cooling like the TriActive,” said Dr. Gold. “What has been developed works, but don’t be surprised if in a year or two we have three or four more devices that work even better.” Disclosures: Dr. Alster is on the Medical Advisory Board for Syneron. Dr. Gold is a stock holder and receives research grants from Cynosure, Inc. Dr. Goldman conducted a research study for Cynosure on TriActive and is doing a research study with VelaSmooth for Syneron. He also owns and developed the SpaMD anti-cellulite cream and bioceramic shorts. Dr. Katz has no relevant financial disclosures.
W hile it is difficult to get a clear picture of the exact size of the cellulite treatment market, some market watchers estimate that American women are spending nearly $6 billion a year trying to banish those unsightly dimples and lumps. What is clear is that the market is enormous and is likely to continue to grow dramatically in the coming years. Today, only a small percentage of women have tapped into the market products and treatment options, but as products get better and treatments become more effective, more and more woman will enter the marketplace. “Ten years ago, cellulite patients were just a tiny fraction of the patients we saw,” said Mitchel P. Goldman, M.D., Medical Director of La Jolla SpaMD and Dermatology/Cosmetic Laser Associates of La Jolla. “Today, we treat about 10 cellulite patients a day, which is about 10% of our medical spa business. We have four cellulite treatment devices at the spa, and we keep all four very busy.” There are a number of reasons likely why the cellulite market is growing; the greater interest in looking young and vital and the general increase in cosmetic procedures are just two. But perhaps the most important factor in the growth of the market is the fact the there are now treatments on the market that actually work and produce longer lasting results. “We have been treating cellulite for a long time, but it has only been very recently that we have been able to achieve significant, longer-term improvement in the appearance of cellulite,” explained Tina Alster, M.D., Director of the Washington Institute of Dermatologic Laser Surgery and Clinical Professor of Dermatology at Georgetown University. “In the early ’90s, we started using the endermologie device, which produced good results in a certain number of patients. Now we have devices, such as the VelaSmooth, that significantly improves the look of cellulite in most of the patients that we treat.” The VelaSmooth from Syneron Medical Ltd. along with the TriActive LaserDermology Cellulite Treatment System from Cynosure, Inc. are two devices on the market that combine the massage operation of the older endermologie approach with various energy sources that deliver heat and — in the case of the TriActive — low-fluence laser and cooling to the treated area. Both devices have been subject to clinical study and both have been reviewed by the FDA and approved to be marketed as devices that can temporarily reduce the appearance of cellulite. TriActive: Massage with Low-Fluence Laser and Cooling The TriActive system employs mechanical massage, localized cooling and laser stimulation to improve the appearance of cellulite. In addition to improvement in skin appearance as a result of the action of the suction massage elements of the device, the manufacturer claims that the energy from the six diode lasers enhances microcirculation. Reduced circulation is often cited as a cause of cellulite. The device also employs selective cooling that the manufacturer says is a key element in the overall effectiveness of the device. “Before we had the TriActive, there was nothing that would reliably address extensive cellulite. Initially, we were very skeptical about the device because we had been down that road before,” explained Bruce Katz, M.D., Director of the Cosmetic Surgery and Laser Clinic at Mount Sinai Hospital and Clinical Professor at the Mount Sinai School of Medicine. “We started using it about a year ago and now it is our preferred method. We use it to treat women who have extensive cellulite, involving the thighs, buttock and hips, and the results have been terrific.” To determine the effectiveness of the laser, Dr. Katz and his assistant Kathryne Frew, M.D., conducted a study involving 10 women with extensive cellulite. In the study, the women were treated on one side of the body with only the cooling and suction massage, which is comparable to endermologie. On the other side, they were treated using all three components, the suction, cooling, and laser. Each patient had 16 treatments. “We noted improvement in 83% of the patients on the side with the laser on, compared to only 17% with the laser off,” said Dr. Katz. “After 3 months, the percentage of improvement remained the same.” Dr Katz will continue to follow these patients to determine how long the effects last. In practice, the procedure is typically done in a series of 10 to15 treatments spaced as closely as three times per week, or as far apart as once a week. Normally the series can be done annually with follow-up monthly maintenance treatments. Each session lasts about 45 minutes and the procedure is relatively painless. Patients often compare it to a typical massage. Results can vary depending upon the patient, the area being treated and the age of the patient. “TriActive is not going to make all of your cellulite go away, but it significantly improves the appearance of the cellulite in the overwhelming majority of women,” Dr. Katz said. “Right now, our trained massage therapists are treating eight to 10 patients a day in our medical spa and they are almost always very happy with the results. They keep coming back for more.” Other physicians have conducted studies that showed the effectiveness of the TriActive device. “If you are going to use a device at your spa, you need to know that there is something more than hype,” commented Michael Gold, M.D., a Dermatologist in private practice in Nashville, TN. “With the TriActive, I know that I have a device that has been reviewed and clinically studied with demonstrated and published results. In our patient population virtually everyone showed dramatic improvement with the TriActive.” VelaSmooth: Massage coupled with RF and IR VelaSmooth uses bi-polar radiofrequency and infrared light along with tissue mobilization and suction to re-contour the skin surface. The manufacture claims that the combined radiofrequency with infrared light soften and rearrange fat and the suction massage stretches the fibrous strands that contribute to the dimpling. “I have been treating cellulite since the early 90s and I was very excited when the VelaSmooth was introduced,” Dr. Alster said. “We had been using endermologie, but the results with that device varied, some patients responded others didn’t. Once we tried the VelaSmooth, we were very quickly convinced that it worked better. I sold my endermologie machine and switched all my patients over to VelaSmooth. They were all were very happy. As an early adopter of the VelaSmooth, Dr. Alster conducted a study examining the effectiveness of the device. The study looked at 20 adult women who had moderate amounts of bilateral thigh and buttocks cellulite. Each patient in the study received eight treatments twice a week to one or the other thigh. The treatments lasted 30 to 45 minutes. The other thigh was untreated. The patients’ weight and leg measurements were taken prior to the start of treatment. “We took digital photographs of each patient prior to each of the eight treatment sessions and at 1, 3 and 6 months after the final treatment and the photos were evaluated by two medical assessors not involved in the treatments,” said Dr. Alster. Clinical improvement scores were made based on a quartile grading scale (0=<25% improved, 1=25% to 50% improved, 2=51% to 75% improved). Side effects were limited to mild transient erythema and bruising (the latter being observed in only two of the patients and occurred only in the first few treatment sessions). According to Dr. Alster, the average clinical improvement score was 1.82, which corresponds to about a 50% improvement. In addition, the circumferences of the treated thighs were reduced on average by 0.8 centimeters or about one third of an inch. “We looked at body weights and nobody had any significant change in body weight so this drop in the size of the treated thigh is related to the treatment,” Dr. Alster explained. “Of the patients, 18 of the 20 (90%) noticed some overall clinical improvement on the treated side. All but one of those indicated that they would pursue treatment of the contra-lateral thigh.” Follow-up showed a slight decrease in the improvement after 1 month with a nearly 50% drop after 6 months. Dr. Alster concluded that there was an additive effect to the treatments and determined that the best course of treatment is 8 sessions, twice a week for 4 weeks. “We know that when you can increase neocollagenesis, you improve the surface appearance of the skin. The heat delivery to the dermis initiates collagen remolding through controlled tissue inflammation and collagen contraction. It’s the combination of the various modalities that delivers the most impact.” The device is very comfortable for the patient, though some patients complain of a pinching sensation on the lateral aspects of the bottom of the thighs. “What I like about this treatment is that it is totally non-invasive, without needles or blood exposure. People can walk in and have this treatment, literally on their lunch hour and they can go back to work,” explained Dr. Alster. “Most patients experience clinical improvement and some even demonstrate marked improvement. It’s an easy outpatient procedure and is not super expensive.” Dr. Goldman uses a number of different treatments for his cellulite patients, including the VelaSmooth. “My staff prefers the VelaSmooth and they think it is the more effective device,” he said. “The patients like it as well as it seems to give quicker results. I can get most of my patients to between 50% and 70% improvement.” However, Dr. Goldman has found that many patients who do not respond to a particular treatment will often respond to another form of treatment. Dr. Goldman is currently conducting a study comparing the VelaSmooth to the TriActive device. Other Modalities: Endermologie, Ionithermie and Subcision Developed in France and in use since the early ’90s, endermologie was the first widely-used treatment option that employed mechanical massage to improve the appearance of cellulite. The FDA currently uses endermologie as its predicate for determining the effectiveness of other massage-based system for cellulite treatment and many physicians continue to use the device to treat cellulite patients. “We have had good results with many patients using the endermologie device and we continue to use it today on a daily basis,” said Dr. Goldman. “It is a less-expensive option and some of our patients prefer the treatment and are very happy with the results.” Another treatment option is ionithermie. With this procedure, the area to be treated is encased in a mixture of clay, algae and other botanical compounds and then wrapped. The area is stimulated with galvanic and faradic electrical impulses. “If a patient wants to look really good quickly, we use ionithermie, because that will usually take off an inch or two and smooth the skin with one treatment,” explained Dr. Goldman. “But that doesn’t last any more than a day.” If treating small areas of cellulite, some physicians use fat harvested from the patient or other body fillers. However, the viability of harvested fat is variable and the harvesting can cause problems as well. Using a filler may produce more predictable results, but if the patient loses weight the fillers can become visible under the skin. For small areas, many physicians will perform a subcision, which involves the use of a specialized needle to cut the fibrous cords causing the depression. “There are some women who have small pockets of localized cellulite and for those areas, we use subcision using a NoKor needle,” said Dr. Katz. “However, it is not an effective way to treat large areas, nor would it be desirable to do so.” Lotions, Potions and Creams Many physicians advocate the use of anti-cellulite creams as part of an overall cellulite treatment approach, though many question their effectiveness and others wonder about the pressure some physicians might put on their patients to buy these products. Dr. Gold incorporates creams into his cellulite treatment program both because he feels that they work, and also because he believes that it empowers the patients to become more involved with their treatments. “When someone says that they have a green tea extract with caffeine that has been shown to reduce cellulite, there is no question that it has.” said Dr. Gold. “We have vitamin-based therapies that incorporate caffeine that if used properly and maintain can help the appearance of cellulite. I am also a big believer in getting the patient to be an active participant in their own treatment and selling them a cream that they take home is one important way to do that.” Dr. Gold advised that at the very least, patients who use creams as an adjunct to treatment with one of the devices can increase the time between treatments. “If a patient spends $50 on a cream that helps her avoid a couple of $100 treatments, then that is cost- and time-effective,” he said. “Keep in mind that they are going to most likely go to a pharmacy and buy a cream anyway, so they might as well buy from a physician who is selling a product shown to work.” Dr Goldman also maintained that the anti-cellulite creams have a place in treatment. “A number of creams are effective in improving the appearance of cellulite. I have two peer-reviewed studies that show that the creams work,” he said. “We actually combine the creams with a bio-occlusive short that aids in the penetration of the cream into the skin.” He goes on to point out that while not as effective as the machines, published studies have shown patients can achieve a 20% to 35% improvement using the creams. What Does the FDA Have to Say? A quick search of the Internet uncovers countless Web sites claiming “an FDA-approved treatment for cellulite.” However, the FDA does not “approve” cellulite treatment devices the way in which it approves new medications. “There are no cellulite treatment devices that can claim to have FDA approval,” explained Richard Felten, Senior Reviewer and Photobiologist with the General Surgical Devices Branch of the FDA. “They can say that the FDA has granted them a 510(k) permission to market the device as a treatment to temporarily improve the appearance of cellulite. When you use the term FDA-approved, people think that the device has been scrutinized to the degree that we would look at a new drug, and that is simply not the case.” Under section 510(k) of the Food, Drug and Cosmetic Act, anyone who wants to market a new or modified medical device has to submit it to the FDA for review. The FDA only determines two things: is the device at least as effective as devices previously evaluated by the FDA for the same purpose and is the device safe. If they determine that it is both effective and safe, they grant permission to market the device for its intended purpose. “The 510(k) process allows a manufacture to go to market with a device based on a comparison of technology and a finding of equivalence in terms of safety and effectiveness of the device,” said Mr. Felten. “For the cellulite devices, we have simply compared the devices to an existing device and determined that the new devices are as effective and as safe as existing predicates without any in-depth review of clinical data.” Demand for Better Treatments will Continue Until there is a cure for cellulite, and at present there is none, women will continue to seek treatments to improve the appearance of their cellulite. As treatments for cellulite continue to improve, the clamor for even better treatments will grow louder. Patients who today are satisfied with a 50% improvement will demand even greater improvement. Manufactures are scrambling to develop these more effective techniques and physicians are lining up to evaluate new technologies and approaches. “Cellulite is the next horizon and it may be an even bigger market than anyone imaged. Every laser company is looking at what they can do differently, tweaking different IPL systems, different diode systems, using suction, using massaging, combining modality, using special cooling like the TriActive,” said Dr. Gold. “What has been developed works, but don’t be surprised if in a year or two we have three or four more devices that work even better.” Disclosures: Dr. Alster is on the Medical Advisory Board for Syneron. Dr. Gold is a stock holder and receives research grants from Cynosure, Inc. Dr. Goldman conducted a research study for Cynosure on TriActive and is doing a research study with VelaSmooth for Syneron. He also owns and developed the SpaMD anti-cellulite cream and bioceramic shorts. Dr. Katz has no relevant financial disclosures.
