BBI Contributing Editor

FLORENCE, Italy True to its motto, "The Renaissance of Dermatology," the 13th Congress of the European Academy of Dermatology and Venereology (EADV; Brussels, Belgium) exposed attendees to a wide range of progressive treatment concepts and innovative aesthetic technologies. The EADV congress was held last November in this city, the site of the first EADV Congress in 1989.

Botulinum toxin was a hot topic at the congress. Its use is quickly expanding in Europe, and botulinum toxin type A is frequently used "as sole treatment or as a building block for the entire aesthetic concept," according to Berthold Rzany, MD, a professor of dermatology at Humboldt University (Berlin). "The focus of treatment has shifted from the frozen face of the 1990s to a smoothened but still expressive face. The goal of treatment today is to treat the mimic muscles more selectively, so that the desirable effect is obtained while still retaining some mimic movements." This kind of treatment requires smaller and smaller dosages of botulinum toxin A, he said. "Treatment with small dosages, however, is a challenge for the physician because individual asymmetries of the face need to be recognized."

Besides treating the upper third of the face, "new indications in the middle and lower third of the face have been developed through precise and accurate application of different dosages and injection techniques," Rzany said.

Dysport from Ipsen Pharma (Ettlingen, Germany) "is a popular botulinum toxin injectable that is efficacious and safe," he said. Indications in aesthetic dermatology are mimic wrinkles, facial contouring and hyperhidrosis. "The patient treatment protocol varies, depending on the strength of mimic muscles and the degree of photodamage, as well as the total area treated," according to Rzany. "After treatment, however, patients can expect a more relaxed, more aesthetic appearance and reduced sweating. You can achieve great efficacy with minimal dosaging."

Either 1.0 ml syringes or 0.3 ml syringes can be used. "The 0.3 ml syringes with a finer graduation (30 units) are especially suitable when very small amounts of Dysport (such as two units per injection point) are used," said Rzany, head of the division of evidence-based medicine in the department of dermatology at Humboldt. Exceptionally fine 30-gauge or 32-gauge needles are used for injection. "The perceived advantage of the 32-gauge needle is that injections feel less painful," he said. "However, there is no solid evidence that this occurs." The standard dilution of 500 Dysport units is accomplished with a 2.5 ml saline solution. "This produces a solution that contains 20 Dysport units in 0.1 ml, or 10 units in 0.05 ml. It is possible to use an increased concentration, for example by using a dilution with 1.5 ml, but this does not provide any advantages."

The standard dosage per injection point is five to 10 Dysport units. "In rare cases in the glabella area and for strongly developed muscles 20 Dysport units may be administered," Rzany said. "Patients with low elastosis require a higher dosage, whereas for patients with increased elastosis, an extremely cautious dosage should be administered."

A follow-up visit should be scheduled two weeks after initial treatment. "At this point, if necessary, a subsequent correction should be undertaken, or else an injection with a filler, a chemical peel or a laser treatment should be started," Rzany said. "Especially when initially using low doses of Dysport, residual wrinkles may remain or existing residual wrinkles may be pronounced. An additional correction should be carried out about two weeks after initial treatment, using the smallest amount of units for example, two to five Dysport units."

Rzany said he feels Dysport "is perfect in combination with biodegradable fillers, microdermabrasion and chemical peels. It also works well with lasers, although I personally do not use them. I believe the future of Dysport is bright."

Botox from Allergan Skin Care (Irvine, California) is another major botulinum toxin A injectable with growing use in Europe. "Botox is a very easy procedure for a trained professional to perform," said Koen De Boulle, MD, a dermatologist in private practice in Aalst, Belgium. "It is also considered a 'lunchtime' procedure. Results are very rewarding. In addition, side effects are minor and totally reversible, if Botox is administered properly. In fact, Botox is the only method in our therapeutic armamentarium to treat dynamic rhytides."

De Boulle pointed out that Botox has a long-standing safety profile, dating back to 1968 for medical use and FDA approval since 1989. "The diffusion pattern of Botox is very controlled. For aesthetic purposes, there are basic and advanced indications. The basic indications include horizontal lines, glabellar frown lines and crow's feet. Advanced indications allow you to perform brow lifts [medial and lateral], bunny lines, zygomatic smile lines and smoker's lines."

After an initial injection, patients are asked to return four months later for a second injection. "On average, after three to six treatments, the interval between visits becomes longer and longer," De Boulle said. "I have patients now who can wait for one year between treatments. And for a medical condition like hyperhidrosis [excessive sweating], that interval can even be longer." Overall, "patient satisfaction is very high. There is a great improvement in dynamic lines. Besides a reduction, there may be disappearance of these lines longer term."

According to De Boulle, 90% of the literature on botulinum toxin is based on the Botox formulation of the compound (type A), and not on the Dysport (also type A) or Myobloc formulation (type B). "Dysport and Myobloc are only marginally written about in the literature," he said. "Botox is also the only botulinum toxin that has peer-reviewed, double-blinded, published studies." He uses Botox in combination with biodegradable, non-permanent fillers or biodegradable, semi-permanent fillers. His favorite combination is Botox and hyaluronic acid. "Botox enhances the effect of this dermal filler material."

De Boulle predicts that Botox will have increasing acceptance in treating the lower face, neck and lower body. "This includes the vertical and oblique lines of the decollate. There are also reports of breast lifting with Botox. There is no question that Botox is one of the major innovations in cosmetic and aesthetic surgery, due to the fact that it has a very safe profile and rewarding outcomes."

Simon Freedman, marketing director for Allergan Europe, said, "Worldwide, Allergan has nearly 90% market share of the neuromodulator market. Botulinum toxin type A is labeled Botox, Vistabel or Vistabex, depending on the indication and country of approval. Our product is widely approved for therapeutic use, with more than 20 indications in over 70 countries worldwide. In Europe, these indications include cervical dystonia, juvenile cerebral palsy, blepharospasm, hemifacial spasm, strabismus, poststroke spasticity and hyperhidrosis."

Freedman added: "For aesthetic use, Vistabel/Vistabex is approved in Switzerland, France, Spain, Italy, Portugal and Scandinavia. There will be a second wave of applications for aesthetic approval in additional European countries by the end of this year."

Dermal filler science evolves

Restylane from Q-Med (Uppsala, Sweden) now comes in five formulations: Restylane (for moderate wrinkles and lip enhancement), Restylane Touch (correction of superficial lines), Restylane Perlane (deep folds, facial contours and lip enhancement), Restylane SubQ (volume augmentation for cheek and chin) and Restylane Vital (rejuvenation). These fillers are all comprised of a crystal-clear, biodegradable non-animal stabilized hyaluronic acid (NASHA) gel, which is injected into the dermis. The distinguishing factor between products is the gel particle size.

"With our Restylane products, physicians can offer their patients a complete solution for tissue tailored facial augmentation a natural beauty lift using the body's own material," said Mikael Svensson, senior marketing director at Q-Med. "The result is instantaneous, producing a long lasting, natural enhancement that is gentle and safe to the skin."

Since its introduction in 1996, "Restylane has undergone extensive histological and clinical studies," Svensson said. "There is an increasing body of evidence relating to its ease of use, tolerability and effectiveness. To date, more than 1.5 million treatments have been successfully carried out worldwide." Both Restylane SubQ and Restylane Vital debuted in 2004. "We anticipate that the effect of Restylane SubQ will last at least 12 months," he said. "Restylane Vital has been mainly launched in southern Europe last summer." Lips usually need to be retreated every four to six months with Restylane, "but other indications can last as long as 18 months," Svensson said. He said that it also is often used in combination with other fillers, especially botulinum toxin.

He predicted that European consumers would increasingly embrace facial injectables. "You're able to achieve a lot with minimal downtime. Most patients show results instantly and treatments may not have to be scheduled that often. Especially with Restylane, treatment for wrinkles and folds commonly need to be repeated only once a year." Biodegradable fillers are where the growth will likely occur, Svensson said. "Frankly, I don't expect that permanent fillers will grow that much. Patients will eventually encounter a problem with these permanent fillers. The question is not if, but when."

New laser technologies

The DioLite 532 laser system from Iridex (Mountain View, California) is the laser of choice for Marco Dal Canton, MD, who is in private practice in Belluno, Italy. "I was particularly attracted by the compact size, minimal maintenance and potential durability of the new diode lasers. I was also excited about the prospect of providing purpurafree treatment for telangiectasias by using a long pulsed 532 nm laser. It appeared to be a device well-suited to the busy, aging population. These patients are searching for rapid clearance of their photoaging signs, with negligible downtime."

Dal Canton said he also was impressed by the reputation and marketing style of Iridex, as well as the positive feedback he had received from colleagues who had used the DioLite 532. "The DioLite is compact, has a small footprint, an easy to read front panel, and a favorable costs/benefits ratio," he said. "Having used the device for a prolonged period now, I appreciate the interchangeable fiberoptic handpieces [200 micron, 500 micron, 700 micron, 1,000 micron and 1,400 micron spot sizes], which are extremely light and effortless to angle. They are apt to trace skin lesions precisely and perpendicularly."

Before using the ScanLite, patients are typically "pre-cooled" with gel packs (a thin layer of water-based 4 C gel). "I use conservative settings with the scanner, usually one pass only, to avoid bulk tissue heating," Dal Canton said. He also sometimes traces specific vascular and pigmented defects with mostly the 500 micron or 700 micron spot. Typically, one to three treatment sessions are required, spaced four to six weeks apart. Apart from approved indications, he said he uses the DioLite to treat some warts. "Compared to cryotherapy, I find the laser to be exceedingly precise and effective on flat warts." He also finds the laser effective for molluscum contagiosum and for select red scars.

Iridex debuted its new dual-wavelength VariLite laser system at the meeting. "The VariLite is cleared for 19 specific indications, including vascular lesions, leg veins, benign pigmented lesions, cutaneous lesions, hair removal and moderate inflammatory acne vulgaris," said Brad Renton, PhD, the company's vice president of aesthetics. "This makes it the most versatile semiconductor-based laser system on the market. The laser is also small, reliable and affordable." Vari-Lite offers both 532 nm and 940 nm wavelengths.

"We have basically taken the DioLite 532 laser system, which has been an extremely popular laser for us, and added a 940 nm direct diode to it," Renton explained. "Of the near-infrared wavelengths, 940 nm is optimal since it has the highest oxyhemoglobin absorption coefficient (9.0 cm-1)."

Bill Kelley, international sales manager for Sciton (Palo Alto, California), said, "It is wonderful to see how the marriage of technologies, or the combined use of lasers, bright light sources, fillers and cosmeceuticals have allowed cosmetic surgeons around the world to dramatically improve the outcomes of their patients." He added: "In the area of devices, surgeons are looking for utility and non-obsolescence in their purchases. They want value for money spent, and the ability to upgrade their capabilities. Industry continues to be innovative and responsive in an effort to fulfill those wishes and needs."

Sciton is just one example of a company trying to meet the needs of the aesthetics market via its multi-platform Profile. "Rather than offering a fixed product design, Sciton allows the surgeon to choose between various laser and light components," Kelley said. "One can mix and match modules, allowing for a diverse range of treatments. Physicians can also add additional modules to the Profile console at a later time. This concept offers a totally flexible arrangement to the buyer. He or she purchases only what they need or want." Applications include pigmented lesions, high-speed hair removal, facial and leg veins, non-ablative rejuvenation, skin peeling, scar revision, port-wine stains, wrinkle treatment and pseudofolliculitis barbae (razor bumps).

Danish Dermatologic Development (Hoersholm, Denmark) manufactures two intense pulsed light (IPL) systems: Ellipse Light and Ellipse Flex. "Ellipse Light is directed at the beauty salons and beauty market segment," said Anders Bjerg, area sales manager for Europe. The two indications for Ellipse Light are permanent hair reduction and skin rejuvenation (including repair of sun-damaged skin). "We call our technology second-generation IPL because of the way we filter the light," he said. "Normally, an IPL system filters the light in only one end of the spectrum. But we filter the light in both ends of the spectrum. Therefore, we achieve a more efficient treatment."

The more expensive Ellipse Flex incorporates the same technology inside, but is targeted to physicians. The system has five applications: hair, vascular lesions, pigmented lesions, photorejuvenation and acne. "The Elipse Flex has so many indications because it is usually operated by doctors or nurses who have the required knowledge of the skin in order to perform these more difficult treatments," Bjerg said.

For today and into the future, Bjerg believes IPL is the most promising light-based technology. "We see a lot of possibilities with future applications. Our devices will likely expand to encompass even more indications. Because of economic development in Europe, the overall aesthetic market is growing, and I don't see any obstacles to continued growth."

One trend affecting growth in Europe is "the proliferation of low-end/low cost products," observed Bill Kelley, vice president of international business at Laserscope (San Jose, California). These include introductory low-cost IPL devices and low-cost lasers. This represents new competition for companies such as Laserscope. It has even reached the point of fee for use; for example, per-pulse charges are an emerging market throughout Europe. This allows the capital acquisition cost to decrease and the doctor can purchase what he uses on the device by purchasing pulses on a credit card.

"On the other hand, we have certainly seen a resurgence in higher-priced quality products, whereby you have multiple applications within one box," Kelley said. "For example, Cutera [Brisbane, California] and Palomar Medical Technologies [Burlington, Massachusetts] market products with multiple wavelengths within a single box," Kelley said. "Candela [Wayland, Massachusetts] also sells multiple lasers within the same accounts."

Noting that "we see a lot of aesthetic practices purchasing multiple lasers or one laser with multiple platforms," Kelley added: "I think the companies that are going to survive are those that are able to effectively solve all the needs of a physician."

He said Laserscope continues to witness growth in the European market. "This consists of our Aura (532 nm) and Lyra (1064 nm Nd:YAG) product line," Kelley said. "We are having more customers buy both products at the same time as opposed to first buying one product, then generating a little revenue before purchasing a second product."

He said he believes there is a lag in technology from the U.S. to Europe. "Some of this is due to the manufacturers concentrated in 'in-country' initial release and some is due to the European market itself looking for validation of the products introduced."

While noting that Europe "lags behind a bit in the number of aesthetic procedures performed," Kelley added: "Interestingly, though, there are a lot more companies and products in the European marketplace compared to the U.S."

The EADV meeting represented the major European launch for Laserscope's Gemini device, which combines and expands on the best aspects of its Aura and Lyra products. "We believe Gemini is going to be a huge product," Kelley said. "With 21 FDA clearances, the Gemini covers 93% of dermatologic indications that a physician is likely to encounter. Gemini will be our ultimate business solution for the aesthetic practice."

The latest edition to the MedArt laser line from Asah Medico (Hvidovre, Denmark) is the MedArt 490, a 30-watt, 1450 nm laser. "The 1450 nm wavelength makes it the perfect choice for collagen renewal," said Bjarne Asah, CEO. "It is the only 1450 nm laser with optional contact skin cooling for increased patient comfort. In addition, the specially developed scanner, a hallmark of our company, secures fast and even treatments. This new treatment modality is a highly promising addition to the aesthetics field."

The MedArt 610 is a 20-watt CO₂ laser and represents a new generation in CO₂ lasers. "It is the world's only CO₂ laser with a super-flexible fiber delivery system. It comes with a 0.3 mm focus point," Asah said. "The flexible fiber is excellent for high-precision surgery because it provides total freedom of movement." The company's 435 laser is a 90-watt, 810 nm for hair removal and vascular lesions.

Asah Medico also has developed ILVO (intraluminal laser vein occlusion). "This is a novel treatment modality which holds a large market potential as a substitute to traditional varicose vein surgery," Asah said.

"Dermatologic lasers are definitely on the rise in Europe," said Ted Barret, international business manager at INTERmedic (Barcelona, Spain), which manufactures and exports lasers to some 18 countries. "Diode lasers, in particular, are becoming more and more common for different applications. These lasers are more effective in treating dermatologic conditions." The basic model of the Multidiode SLP from INTERmedic treats hair only. Upgrades are for wrinkle reduction and vascular treatments.

INTERmedic also offers three models of the Multidiode Endo Laser for endovenous treatments. "We feel physicians, hospitals, consultation rooms and private clinics are increasingly becoming familiar with the usage of lasers," Barret said. "These lasers are replacing the old cutting knife and other ablation methods. Results are more effective, less painful and more cost-effective with lasers."

The company launched a new multi-platform dermatologic/medical system called ContrAge at EADV.

Dominique Rheims, MD, a plastic surgeon in private practice in Paris, said he finds the SkinStation Clinical Phototherapy System from The Radiancy Group "a useful complementary tool to my aesthetic surgery. Reported results with the SkinStation are very good and appear better than comparable technologies." The SkinStation is powered by LHE, which combines light with heat energy. "I believe it is safer than most lasers," Rheims said. He uses the SkinStation to treat photodamaged skin, such as black marks on the face and fine wrinkles around the mouth.

Rheims has also had "very satisfactory results" treating acne patients with the SkinStation. For a surgical facelift, he sometimes uses the SkinStation to prepare the skin beforehand. He also may use it a few months afterwards, especially if there is a lot of photodamage.

The new Titan from Cutera is a unique infrared light source with concurrent cooling to heat the skin. "Titan is used for the correction of lax skin, non-invasively," said Javier Ruiz-Esparza, MD, a dermatologist in private practice. "Treatments can be repeated as often as necessary. But you can see results from only one treatment. To date, he has treated about 15 patients with the Titan on the lower face, neck and forehead for eyebrow lifting. "We are also doing arms, thighs and abdomen. You can perform treatment without anesthesia, since it is virtually painless. Results are also immediate, so patients love it."

Despite what he sees as advantages of infrared light over radio frequency, Ruiz-Esparza said he believes that in the future the Titan will be used in combination with the ThermaCool TC system from Thermage (Hayward, California) rather than the two devices being in competition. "Both systems can be used in the same session," he said.

Claudio Coscia, director of marketing for Europe at Cutera, said, "the aesthetic market has changed a lot during the past three years perhaps more in Europe than in the U.S. Obstacles such as [FDA] regulations and the costs of distribution are preventing smaller companies [from penetrating] the North American market. But there are a vast variety of lasers and other light-based systems offered in Europe."

Noting that IPL technology is widely accepted in Europe, Coscia said Lumenis (Yokneam, Israel) and Danish Dermatologic Development are the two strong players, but that "a countless number of small manufacturers are around as well." He said such companies "offer low-tech devices with minimal service, but extremely low prices. I believe this lowers the overall reputation of our industry and it also confuses the customers."

With competition within the medical community heating up, "physicians have to offer a range of aesthetic applications," Coscia said. "Three or four years ago, providing hair removal alone was acceptable. But today, physicians need to offer procedures like fillers, Botox and microdermabrasion. The progressive aesthetic clinic needs to offer a full range of non-invasive treatments. This includes the removal of unwanted hair, treatment of vascular and pigmented lesions, the improvement of skin quality and tightening of the skin." He maintains that with the introduction of the Titan, "Cutera is the only manufacturer offering a solution to all these needs. Moreover, all indications can be treated by one very economical platform."

Light-emitting diode (LED) technology is a growing aesthetic sector in Europe. "I don't think there is any question that LED systems will have a greater impact in Europe going forward. In fact, I believe these LED technologies hold the most promise among light-based devices," said David Goldberg, MD, a clinical professor of dermatology at Mount Sinai School of Medicine (New York). "The appeal of these systems is that they don't hurt at all and they are less expensive than lasers and other light sources. Treatment may only take minutes."

Three new LED systems from UK-based Photo-therapeutics have entered the market. "The company has a red-light LED, a blue-light LED and a nearinfrared LED," he said. "Basically, each wavelength of light has a different effect on the cells in terms of lessening sun damage and protecting cells from environmental toxins."

The Galaxy system from Syneron Medical (Richmond Hill, Ontario) is becoming one of the most sought-after multi-application aesthetic technology platforms in the world. Currently, five different treatment heads are available with the Galaxy: hair removal, skin rejuvenation, wrinkles, leg vein/vascular and acne. The hybrid design is powered by elos (electro-optical synergy), the technology that combines energy sources light and bipolar radiofrequency. The addition of RF energy with the Galaxy "allows deeper penetration of heat, thereby stimulating more collagen production and overall better skin elasticity and textural improvement," said Stan Kovak, MD, a Chicago area cosmetic physician.

Reliant Technologies (Foster City, California) featured its new Fraxel SR Laser at EADV as an emer-ging trend in the growing aesthetic laser field. It combines ablative and non-ablative technologies by repairing periorbital wrinkles and pigmented lesions without the drawbacks of traditional ablative resurfacing.