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Fractional skin resurfacing technologies like Fraxel, Lumenis ActiveFX, DeepFX, Palomar Starlux 1540 and Starlux 2940, and are quickly becoming familiar to many cosmetic, dermatology, plastic surgery and medical spa practices.

The history of laser skin resurfacing goes back to 1995, when the first full face CO2 laser resurfacing for wrinkle removal was performed. The procedure was a revolution in facial laser surgery. A flock of lasers were developed primarily for plastic surgeons. The procedure was done under general anesthesia and created a burn wound, which took 7-10 months to heal. The hypo pigmentation that followed for about another 10-12 months was normal and fairly well accepted for a few years due to lack of other options.

The next advance in laser skin resurfacing was the development of Erbium (Er:YAG) lasers. They became available to plastic and dermatology surgeons around the year 2000. These were, and continue to be very effective for the resurfacing. Erbium lasers are a lot safer and cause a significantly reduced downtime for the patient. At about the same time fewer patients wanted to have a full face resurfaced as a nicely done areas around the eyes and mouth created a very comparable overall aesthetic result with even faster healing and shorter downtime. A mild laser peel will give most patients an excellent result with about one week of “take it easy” time.

Fractional laserswere introduced to the aesthetic market in 2002-2003 with a big bang and glitzy and very effective promotions by Reliant, which pioneered the fractional photothermolysis. The idea was to bring about a laser that would be non-ablative,  but as effective as the ablative lasers (the CO2 and Erbium) before it.

Fraxel laser by Reliant was the first non-ablative fractional laser for the cosmetic medical market and it gave birth to the first generation of non-ablative fractional lasers. While there were a lot of hype about these non-ablative fractional lasers, the clinical fact is that they had categorically fallen short of the goal of ‘profound results with zero downtime.’ As we have seen with these devices, patients had to tolerate painful treatment in multiple sessions while still enduring disruption of the epidermis and thus multiple episodes of downtime, before the final outcome, which also failed to meet expectations. Fraxel has been upgraded and improved by a number of other competing fractional laser skin resurfacing technologies such as the Lumenis DeepFX and ActiveFX, Palomar Starlux 1540, and Starlux 2940. The newest fractional skin resurfacing technologies employ the use of erbium lasers and may be non-ablative (Fraxel re:fine, Fraxel re:store, Palomar Starlux 1540) or ablative (the newest generation of fractional lasers). The laser beam is ‘fractionated’ into tiny micro-lasers, treating only a small portion of the skin (MTZ – microthermal zone, or sometimes called microscopic treatment zones) and leaving surrounding skin tissue undamaged. The goal is to speed up the healing.   These MTZs cause enough injury to the dermis to trigger new collagen production and stimulate the replacement of collagen damaged by aging and sun exposure. This production of new collagen ‘fills in’ or ‘plumps’ the underlying dermal tissues and smoothes wrinkles. The surrounding, untreated skin speeds the healing process to a mere 3-4 days. Since most of the pigment cells remain intact, hypo pigmentation is effectively prevented. The Fraxel re:fine, Fraxel re:store and Palomar Starlux 1540 are non-ablative lasers that don’t actually vaporize or remove the skin. Instead, the laser instantly heats MTZs, causes the thermal damage, which stimulates new collagen growth during the healing process. Results for wrinkle removal and skin tightening are less dramatic than with any ablative lasers, but some patients may appreciate the benefit of reduced recovery time and fewer side effects.

Fractional Ablative Laser Resurfacing

The newest generation of fractional lasers (Starlux 2940, Lumenis ActiveFX and DeepFx systems and Fraxel re:pair) use the ablative skin resurfacing, i.e. CO2 10600 nm or Erbium 2940 nm. They are designed to offer the best of both worlds: fractional treatments with less downtime and reduced complications and ablative laser skin resurfacing for better wrinkle removal and facial rejuvenation. These lasers actually remove tissue in the micro treatment zones, providing much better cosmetic result for patients with heavily wrinkled and sun damaged skin. These lasers provide “rapid remodeling from the inside out”: the fractional treatment results in both rapid reepitheliazation of the epidermis as well as collagen remodeling to depths of 1.6 mm. The skin heals much faster than if the entire area were treated at once, because the treatment uses the body’s natural healing process to create new, healthy tissue that replaces skin imperfections – such as wrinkles, melasma, dyschromia, actinic ketatosis, pigmented lesions, acne scars and surgical scars.

Actifirm Post Laser Gel combines skin-soothers like Aloe and Chamomile with a Mushroom-derived, exfoliating enzyme, Mucor Miehi Extract, to inhibit pain and inflammation, while helping renew your skin to its freshest form. You’ll be looking your best in no time.


More skin care recommendations by LaserOffers.com

Fractional treatment works on and off the face, including delicate areas like the neck, chest and hands. This is a huge advantage over previous generations of ablative lasers, which required a truly skilled hand to work on these areas.

There is some increase in recovery time:  clinical downtime of 2-3 days (reepitheliazation of epidermis) and 5-7 days of social downtime (time for patients to resume regular activities). Thus the overall downtime is comparable to the downtime after a traditional non-fractional erbium ablative laser treatment.

LaserOffers.com comment

Leaving the laser skin resurfacing by pulsed non-fractionated CO2 lasers in the past (where it belongs now), most experts agree that the newest generation of fractional lasers, which uses ablative technologies (Erbium or CO2), have approached the clinical efficacy achieved by traditional Erbium resurfacing. The pain for the patient, downtime and potential side effects are comparable. It is up to the physician to define what patient will benefit more from the subtle difference between these lasers. In time when value and ROI are particularly important, the cost of acquisition of either type of the ablative laser will be the best helpers to the physician.

S. Brown, PhD et al

Characterization of Non-thermal Focused Ultrasound for Non-invasive Selective Fat Cell Disruption (lysis): Technical and Pre-clinical Assessment

currently available on PRS Advance Online at http://www.plasreconsurg.com

In this new paper, Spencer Brown MD et. al. performs four pre-clinical experiments to elucidate the acute biological effects of the Ultrashape device for non-invasive fat cell disruption.  Brown’s five co-authors are Ultrashape employees.  In general, the presented work appears to be careful and the results accurate.  Unlike the previously reviewed Zeltiq pre-clinical study, however, several important pre-clinical experiments were not performed, so we still do not know how the acute biological effects of the Ultrashape device are related to ultimate clinical outcomes.

In the first two experiments, the authors characterize the energy delivery of the UltraShape probe in water, which is a standard method for characterizing ultrasound energy fields.  Brown shows that the device focuses the ultrasound energy in a volume that has a diameter of about 8mm, and a depth that ranges from about 5mm to about 25mm from the probe.  Brown shows that the energy density (power per cm2) at the probe-water interface is very small, as desired.  Further, the authors showed that the ultrasonic energy created air bubbles in the focal region, consistent with a non-thermal cavitation effect.  Quantitative measures of ultrasonic power density were performed at 0mm and 14mm depth, and showed an absence of “hot spots.”  An improvement to the study would have included power density measurements at 1.5-2mm (approximately the depth of the dermal-fat junction) and 25mm (to characterize the extent of the ultrasonic energy transmission).

In the third experiment, the UltraShape probe was characterized in a gel phantom intended to simulate the ultrasound transmission properties of skin and fat.  In this case the focal volume was 9mm in diameter (slightly less focused than in water) and extended about 18mm in depth (the distance from the surface was not reported, but appears to extend from about 4mm to 22mm from the probe according to the figure).  Again, bubbles were seen in the focal region in this model, consistent with a non-thermal cavitation effect. 

In the fourth experiment, porcine skin was treated and then immediately evaluated with both frozen sections and histologically stained sections.  Untreated control skin was also evaluated to ensure that results were not due to processing artifact.  Importantly, no effect on skin color or skin appearance was seen on the animals receiving this treatment, and histology showed that the dermis and epidermis appeared to be completely unaffected by the treatment.  The subcutaneous fat, however, showed evidence of tissue injury in both the frozen sections and the histology.  Histological staining for LDH activity using NTBC (elevated levels of LDH indicate tissue breakdown) demonstrated a layer of adipocyte cell breakdown extending from about 15mm to 25mm of tissue depth.  In the treated tissue, but not the control tissue, frozen sections and two other histological stains (H&E and Masson’s Trichrome) indicated a “defined area of tissue destruction” extending from approximately 8mm to 18mm of tissue depth.  This region showed clear disruption of fat cells, while connective tissue, blood vessels and nerves remained intact.  No evidence of any thermal damage was seen in any treated tissue, again “consistent with initial cavitation followed by the mechanical destruction of cells.”  The authors state that fourteen animals were treated in this study, and the results were “consistent over time” despite the use of “multiple devices, [and] multiple transducers [by] numerous users.”  No quantification of subject-to-subject variability was provided.  For example, the authors should have measured the zone of tissue damage in each animal, and presented the results as averages with 95% confidence intervals.

So far, the results are promising, with clear evidence of non-invasive damage to subcutaneous fat and no apparent impact to the dermis.  Unfortunately, the analysis stops there.  For example, it is clear from the presented images that not all fat cells in the treated region were disrupted, but the authors do not quantify the percentage of the treatment volume that was disrupted.  Further, the response of the animal to this treatment was not studied.  Biopsies of treated and control areas were not performed at meaningful time durations subsequent to treatment (such a 1 day, 1 week, 1 month and 3 months post-treatment).  Unlike the recent Zeltiq study, we have no idea how the skin and subcutaneous fat respond to these injuries.  Does inflammation occur?  While no changes to the histology of the dermis were seen immediately post-treatment, could an inflammatory response occur over time?  Are non-viable cells removed or replaced?  Does this treatment cause meaningful changes in fat thickness compared to control volumes over time, and if so, when do these changes occur?  Lastly, blood lipid profiles were not analyzed in this study.  We cannot know if release of lipids from the disrupted adipocytes has any systemic effect, either on blood lipids or the liver.

The authors state that these study “observations do not directly lead to predict clinical results,” and they recommend further clinical evaluation.  However, the real need is for further pre-clinical evaluation.  Perhaps this partly explains why this device, widely available in Europe and Canada, is not yet cleared by the FDA.

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  • Filed under: Device Review, MedSpa
  • Fraxel Re:pair versus Face Lift

    Last week, Solta Medical presented a study by Steve Weiner, MD at the annual American Academy for Dermatology meeting. The presentation sparked a few discussions among doctors who have had some experience with the “new Fraxel”.

    Fraxel Re:pair is a “non-invasive” laser treatment used for the reduction of fine to moderate wrinkles on the face, neck and chest. “As a plastic surgeon I’ve found this to be the best treatment on the market to date and I don’t anticipate anything will replace it for many years,” said Weiner. Some may argue that Dr. Weiner’s opinion is biased since he did the study on the Solta’s buck and featured his patients at several nationwide webinars promoting Solta’s lasers. However, Weiner’s research clearly shows the advantages of his technique, which are very valuable for many physicians.

    How does Fraxel Re:pair compare to a traditional face lift?

    A face-lift is a surgical procedure under general anaesthesia performed by a plastic surgeon, often in a specialized outpatient center or a hospital. The Fraxel Re:pair is considered to be a non-invasive treatment with the use of CO2 laser technology, which can be done by physicians of different specialties and in a doctor’s office. Results are expected to last up to 10 years. For most patients only one treatment is required, for deeper wrinkles two may be necessary, according to Weiner.

    The laser effectively removes portions the epidermis and heats the dermis to tighten the skin and help with collagen elasticity, referred to as resurfacing. As with other laser treatment the new skin is exposed and wound care is necessary. This is the part where one may question the definition of a non-invasive treatment. After the Fraxel treatment the patient goes home with dressings on the face. The dressings need to be changed every 3-4 hours and you have to stay indoors for 5-7 days. Most patients would arguably call this pretty invasive.

    The Fraxel Re:pair seems to work very well on mildly deep wrinkles, acne scars and brown spots, caused by the sun exposure. With some extra skill and experiens a doctor can work with Asians and Hispanics. Smokers and individuals with heavily tanned, pigmented or very dark skin types are not good candidates for this treatment.

    The cost for Fraxel Re:pair ranges from $1,300 to $6,300, approximately 1/3 the cost for a surgical face lift which can cost more than $10,000.

    LaserOffers comment

    Our medical panel agrees that leaving the issue of cost differential aside, for the vast majority of patients the CO2 fractional treatment with Fraxel will work just as well, if not better than the surgical face-lift. The additional benefit is that the laser actually improves the skin texture, whereas the lift merely stretches the skin.

    Actifirm Post Laser Gel combines skin-soothers like Aloe and Chamomile with a Mushroom-derived, exfoliating enzyme, Mucor Miehi Extract, to inhibit pain and inflammation, while helping renew your skin to its freshest form. You’ll be looking your best in no time.


    More skin care recommendations by LaserOffers.com

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  • Filed under: Laser Clinics, LT | fractional, New Lasers, Research
  • J Cosmet Laser Ther. 2009 Mar;11(1):34-44
    Bousquet-Rouaud R, Bazan M, Chaintreuil J, Echague AV.
    Dermatological Laser Unit, Millenium Clinic, Montpellier, France.
    http://www.ncbi.nlm.nih.gov/pubmed/19214861

    This article presents the first evaluation of the use of a high-power pulsed Nd:YAG laser for the treatment of cellulite.  Three of the four authors are employees of Candela Corporation, the maker of the laser.

    The study at first appears to be well-designed.  Quantitative endpoints of dermis thickness and ultrasound density were chosen, and preliminary studies were performed to show that measurement methods were not subject to intra-observer or inter-observer error.  Twelve patients were treated, with one thigh randomized to treatment and the other randomized to control.  In addition to pre-treatment ultrasound measurements, follow-up measurements were performed at 1 month and 3 months after the final treatment of the series of three treatments.  Adjunctive photographs were taken before each treatment, and presumably at the follow-up visits.  The example photograph appears to be of high quality.  The treatments were appropriately standardized to minimize the impact of dosage variation on outcome.  Likewise, the patient population appears to be reasonably homogenous in terms of age, body mass index, and pre-treatment evaluation of cellulite severity, to minimize the impact of patient variation on outcome variation.

    Given the apparent care taken in the study design, the analysis was extremely disappointing.  The analysis presents only the variation in ultrasound measurements of the treated thigh, and completely ignores the control thigh.  The authors claim that the mean dermal thickness of treated thighs decreases from the beginning to the end of the study, but this is a flawed claim.  Because they do not present data on the control thigh, we cannot know if this result stems from a treatment effect, or from a natural variation in the patient population over time.  For all we know, the dermal thickness of the control thigh improved more than the treated leg.  This is the whole point of having a control thigh.  No other control variables, such as BMI or weight, were presented.

    Further, the authors include the raw data for the dermal thickness measurements in all 12 patients, but offer no explanation why some patients have increased thickness at 1 month follow-up which then decreases at 3 months, while other patients show decreased thickness at 1 month with subsequent increases at 3 months.  Presumably, the treatment effect would go in generally the same direction in this homogeneous group that recieved the same treatment regime.  This variation adds to the concern that something else was going on with these patients during the study that might effect dermal thickness.  The same comments apply to the raw data on dermal echogenicity.

    The exclusion of measurements of the control thigh from the analysis renders any conclusions moot.  The authors further present patient satisfaction data.  This type of data is notoriously challenging to interpret, as patients often feel satisfied that they are taking steps towards treating a condition. In this case, on average the patients reported being somewhat satisfied, and no patients reported being very satisfied.  Readers of the article should not be satisfied at all.

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  • Filed under: Device Review, LT | cellulite, MedSpa
  • AAD launches today include the Aesthera’s acne system with the peer reviewed clinical paper titled “Treatment of Acne with Photopneumatic Therapy,” by Tina S. Alster MD et al. The paper studies the clinical efficacy of Photopneumatic Therapy for the treatment of mild to severe facial acne. “Our study noted greatest improvement in patients with severe acne. We are pleased with treatment outcomes, especially for severe acne,” said study co-investigator Dr. Alster. The study was performed using Aesthera’s ISOLAZ system, the only FDA cleared device for the treatment of Comedonal and Pustular Acne.

    Aesthera is launching Profusion(TM) – (Pro for Professional and Fusion is a Combination) – a skin therapy that combines the Photopneumatic light treatments with the delivery of Aesthera’s proprietary skincare to enhance skin treatment outcomes for acne, skin rejuvenation and body tightening. “Profusion’s novel mechanism has tremendous therapeutic potential for innovative new applications. We are very excited about its clinical potential,” says Vic Narurkar, MD, Chair of Dermatology at the California Pacific Medical Center (CPMC) in San Francisco, CA. “Profusion Skin Therapy is the fastest growing procedure in our practice. We routinely perform it in combination with the majority of skin treatments we offer,” he adds. New applications of the technology include body tightening and skin lightening.

    Body Tightening Technology. What’s it all about?

    It is about Photopneumatic(TM) Technology, a delivery mechanism, and the applicator that will allow for high treatment precision and focused energy delivery. The patient benefits of Aesthera’s unique solution will be fast, painless, and extremely precise treatments.

    Photopneumatic Therapy, that powers the Isolaz(TM) and Isolaz Pro(TM) system, is a proprietary combination of pneumatic energy and broad band light. Photopneumatic devices are the only laser or light based devices cleared by FDA for the treatment of inflammatory acne, comedonal acne and pustular acne. They are also cleared for the treatment of mild to moderate inflammatory acne. Photopneumatic treatments have an immediate visible impact on acne 24 – 48 hour post first treatment and are painless. Facial treatments take approximately 10 minutes, require no anesthetics or numbing creams and provide additional cosmetic benefits such as smoother appearing skin. Additionally, Photopneumatic treatments have an immediate visible impact on acne 24 – 48 hour post first treatment and are painless. Facial treatments take approximately 10 minutes, require no anesthetics or numbing creams and provide additional cosmetic benefits such as smoother appearing skin. Additionally, Photopneumatic Therapy is also cleared for the treatment of benign vascular and pigmented lesions and hair removal.

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  • Filed under: Device Review, LT | acne, Market | businesses, New Lasers
  • Cynosure has a new machine for the American Academy of Dermatology’s 67th Annual Meeting in San Francisco – Elite MPX for its Smartlipo MPX laser lipolysis workstation.

    Through the company’s patented MultiPlex(TM) technology, Elite MPX combines two wavelengths — 755nm Alexandrite and 1064 nmNd:YAG – along with Xenon Pulsed Light (XPL2) technology to create one of the industry’s most powerful workstations for vascular treatment, hair removal and skin rejuvenation. In addition, Cynosure is introducing two new intelligent delivery systems for the Smartlipo MPX workstation for laser lipolysis: SmartSense with ThermaGuide and ThermaView, the world’s first subcutaneous temperature sensing technology and thermal imaging system for Laser Body Contouring.

    Elite MPX incorporates Cynosure’s proprietary MultiPlex technology, which sequentially fires two wavelengths for more effective treatments than single-wavelength systems. A completely new software system runs the graphically enhanced Graphic User Interface, which makes its operation simple and easy.

    The workstation also features a built-in Zimmer SmartCool(R) skin cooling system that is exclusive to Cynosure. Rather than requiring a separate SmartCool device, Zimmer technology is integrated into a single compact module, saving precious office space and reducing treatment time. In addition, the Elite MPX includes eight different spot sizes, including an 18mm spot size that results in 44% more treatment area per pulse than standard spot sizes.

    “Cynosure’s Elite MPX is a powerful and versatile system that enables clinicians to customize treatments for a broad range of skin types and conditions, including sun-damaged skin, pigmented lesions, dyschromia and rosacea,” said Emil Tanghetti, M.D., Clinical Professor of Dermatology at the University of California, Davis and Director of The Center for Dermatology and Laser Surgery, Sacramento, California. “As practitioners, we are seeing a growing cultural diversity within our patient base, and I expect the Elite MPX will provide benefits across the spectrum of applications for these patients.”

    According to InMedica, the worldwide demand for hair removal, pigmented lesion removal and vascular lesion removal is expected to increase from $650 million in 2007 to $750 million by 2010.

    SmartSense with ThermaGuideis equipped with a thermal sensing cannula for measuring temperatures in the subcutaneous areas of the body. This technology allows the practitioner to set temperature thresholds to achieve targeted and controlled energy delivery for a safe and optimal clinical endpoint.

    The ThermaView thermal camera system measures skin surface temperature and provides a visual map of temperatures within the treatment area in order to provide a homogeneous delivery of thermal energy. This intelligence is integrated into the Smartlipo MPX system. As a result, thermal energy is delivered to a targeted temperature setting, helping to ensure the safe and effective treatment of the superficial layer of the surface area.

    LaserOffers.com comment

    Many people will call these advances bells and whistles. We disagree. Cynosure has come up with a lot of real technological advances rolling out this system. High capacity, large volume clinics will benefit from it, if they can afford it. All it takes to get your money back is a few hundred patients a month. Every month.

    Many consumers bombard laser manufacturers looking to buy a hair removal laser for home use. “The price for a full body hair removal at a medical aesthetic clinic is over $3,000. Why can’t buy a laser and do it myself and share the laser with the family?” Most people are surprised that even for a used light-based device for hair removal medical professionals have to pay upwards of $50,000.

    Why laser manufacturers do not make devices for consumers?

    The simple answer is: laser hair removal devices are not a consumer technology. It’s not a matter of cost. Some consumers might consider footing a $50K bill for personal use. It’s not a matter of making the laser technology cheap and affordable to general public. Due to safety considerations lasers should never be used without medical supervision.

    The home-based market for aesthetic devices is a potential source of significant growth for the aesthetic industry.  While this seems to represent a considerably larger market opportunity than the professional aesthetic equipment market, we believe that even cheap low power home-based hair removal devices will be competing against conventional razors, electronic razors, waxing products, light-based epilation, electrolysis, bleaching, and hair growth inhibitors. For skin rejuvenation, some of the leading alternatives include conventional facials, chemical peels, and microdermabrasion, which are competitively offered by day spa kind of outfits.

    What consumer laser devices are avaialble now?

    Palomar Medical Technologies has made the most advanced attempt into the field. Years ago they forged a what seemed a guaranteed success partnership with Gillette to develop and commercialize a home-based hair removal device. It was very long in the making and recently Gillette waived the exclusive distribution rights to the device, which seems like a clear indication that the device did not meet internal expectations during the 12-month consumer assessment trial. The future of the project is unclear.

    Privately held Radiancy introduced its homebased hair removal device, no!no!, in October 2007 in the U.S., which is exclusively offered through cosmetics retailer Sephora at $250 per unit. The company’s approach to market was unique in that it contracted directly with a single retailer that has a national presence as opposed to consumer products distributor capable of reaching multiple retail outlets (the approach currently being pursued by Syneron and Palomar). We believe that Radiancy is expanding its home-use line to include solutions for acne and facial skin rejuvenation.

    All patients who used Silk’n, a low-energy pulsed-light device intended for home-use hair removal, showed a positive clinical response to treatment in a controlled study by the Washington Institute of Dermatologic Laser Surgery, which was published in mid-March 2009. Hair counts were reduced 37.8% to 53.6% 6 months after three treatments. Skin region influenced clinical response, with lower legs exhibiting greater hair reduction than arms and inguinal and axillary areas. Mild erythema was experienced in 25% of patients, but no other side effects or complications were encountered. Patient satisfaction scores were high, with all patients stating that they would purchase the device for future home use.

    It appears that this low-energy pulsed light device can be applied safely and effectively for at-home hair removal in a variety of nonfacial locations and skin phototypes I-IV. These devices are available via a limited number of physicians in the U.S.

    Other devices, such as nuFace and Zeno, are not using laser technologies.

    LaserOffers.com. It is highly unlikely that consumers will see an affordable but effective light-based device for permanent hair reduction or photorejuvenation in a store near you in the many years to come. The long-term efficacy of the experimental devices listed above is incomparable to any hair reduction treatments offered by professional IPLs and lasers.

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  • Filed under: CURRENT NEWS, Device Review, LT | hair removal
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