Alaser system for skin rejuvenation that delivers ablative fractional resurfacing technology made its official debut at the annual meeting of the American Academy of Dermatology.
Manufactured by Mountain View, Calif.-based Reliant Technologies, the 10,600-nm CO2 Fraxel re:pair laser uses a continuous motion handpiece to create microscopic "zones of treatment" evenly across the surface of the skin. Clinical studies have demonstrated that it can treat up to 6 g of dermal tissue in a single treatment session with depths that range from 300 mcm to 1.6 mm, according to the manufacturer.
In May of 2007 the device was cleared by the Food and Drug Administration for ablation, coagulation, and skin resurfacing. In December of 2007 it received FDA 510(k) clearance for the treatment of wrinkles, rhytids, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia. The current retail price of the Fraxel re:pair system is $129,000.
Studies of the device have included about 500 treatments over the last 2.5 years. In one recent study of its use on the forearm skin of 24 subjects with Fitzpatrick skin types II-IV, researchers tested pulse energies that ranged from 5 to 40 mJ and used hematoxylin and eosin to assess the legions histologically (Lasers Surg. Med. 2007;39:96107). They found that changing the pulse energy from 5 to 30 mJ created a threefold increase in lesion depth and a twofold increase in width.
"Interestingly, ablative fractional resurfacing demonstrated much more rapid reepithelialization when compared to its nonfractional predecessors, whether powered by erbium or CO2 lasers," reported the researchers (some of whom were employed by Reliant), led by Dr. Basil M. Hantash of Stanford (Calif.) University. "By 48 hours, most subjects demonstrated complete reepithelialization."
Subsequent studies of the system have used pulse energies that reach 70 mJ.
In an interview, one of the other study authors, Dr. Christopher Zachary, chair of the department of dermatology, University of California, Irvine, said that as long as physicians work within the recommended parameters, the Fraxel re:pair system "is going to give you a very predictable and reliable result and it's going to be much safer than the traditional carbon dioxide or erbium YAG lasers, which were associated with persistent redness, loss of pigmentationwhich is delayed and permanentscarring, and so forth."
In most cases, one treatment is sufficient and downtime is 24 days depending on the parameters used. "On day 5 you have redness and swelling," said Dr. Zachary, an unpaid consultant to Reliant Technologies.
Dr. Zachary said that he has limited experience using the device in dark-skinned patients, but "I absolutely intend to use it [on dark-skinned patients] on a regular basis," he said. "Darker skin types are going to have problems with skin pigmentation. To prevent it, we are pretreating for at least 2 weeks with a bleaching agent such as hydroquinone 4% cream, which will reside within the normal untreated skin after you have treated a fraction of the skin. That area that you do not treat will have a reservoir of hydroquinone which tends to prevent increased postinflammatory hyperpigmentation."
Trials are currently underway to study the use of the Fraxel re:pair system for treating acne scars, surgical scars, and striae. Dr. Zachary said that patients with severe acne scarring "are probably going to have two to three treatments separated by about a month each."
Dr. Robert A. Weiss, president-elect of the American Society for Dermatologic Surgery, called the Fraxel re:pair system an "elegant device" and noted that ablative fractional technology "is the next phase of fractional. It really does give a lot more improvement."
Dr. Weiss, who practices in Hunt Valley, Md., said that he currently uses a competing fractional laser procedure from Lumenis Ltd. called ActiveFX, which is delivered by the company's UltraCool Encore CO2 system. Dr. Weiss is a member of the medical advisory board for Lumenis Ltd.
Dr. Zachary disclosed that he has received equipment and honoraria from Reliant Technologies and that he serves as a consultant for other laser companies.
A patient is shown before (left) and 1 month after treatment with the Fraxel re:pair laser, which is said to demonstrate "more rapid reepithelialization." Photos courtesy Dr. Zakia Rahman
