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Therapeutics Update Product News Gaining Clarity. Patients with acne may be pleased to know that a brand-new OTC agent has recently become available. Stiefel, a GSK company’s, new acne regimen, The MaxClarity regimen, is now widely available. MaxClarity uses VersaFoam Technology to enhance penetration of benzoyl peroxide and salicyclic acid. New clinical data indicated that two thirds of patients experienced significant improvement in acne with one week of use of MaxClarity, while 80 percent of users experienced clinically significant improvements at four weeks, according to Stiefel/GSK. The system includes a Deep Cleanser, Advanced Acne Treatment, and Rejuvenating Toner. Purchases can also be made online at www.maxclarity.com. Before Zeltiq CoolSculpting Coming to Practices. A novel, non-invasive fat reduction device, Zeltiq has earned FDA clearance for treatment of the flank areas of the torso. Based on the science of After Zeltiq Cryolipolysis or cold lipolysis, Zeltiq’s unique CoolSculpting technique involves use of advanced cooling to gently and effectively reduce fat bulges in targeted areas of the body without needles, incisions, pain medication, or recovery time. Fat cells are naturally more sensitive to the effects of cold than other cells, the developer explains, permitting the device to target and kill only the underlying fat, leaving surface skin tissue unaffected. Among patients treated at 12 centers nationwide, there was an average fat layer reduction of 20 percent at four months after only one procedure. Restoring Balance. The latest product in the Cetaphil line is designed specifically to manage symptoms of eczema. Cetaphil Restoraderm Skin Restoring Body Wash and Skin Restoring Moisturizer soothe itch by enhancing the skin’s ability to restore hydration and repair the epidermal barrier. The Skin Restoring Moisturizer contains a combination of filaggrin break- down product and ceramides, while the Skin Restoring Body Wash rebuilds the lipid bilayer during bathing, allowing for maximum replenishment of moisture, Galderma says. Cosmetics For a Cause. For the launch of their new pink Radiance Bx Finishing Lines + DMAE (dimethylaminoethanol) anti-aging treatment in October 2010, Mesoestetic will donate 10 percent of proceeds from the month’s sales of the product to breast cancer research. DMAE is an anti-flaccidity agent that penetrates deep into the dermis to strengthen the connective tissue and stretch the skin’s surface, producing an immediate lifting effect, Mesoestetic says. Other ingredients include Acetyl Hexapeptide-3, Palmitoyl Pentapeptide-3, Palmitoyl Tripeptide-3, Ascorbyl Glucoside and common oat seed extract, which work collectively to stimulate collagen and enhance skin elasticity and firmness. Peel in a Jar? With an effective pH of 2.1 to 2.3, Lexli daily exfoliant differs from other OTC products because it contains an effective pH near that of a chemical peel, according to developer AloeGlyC. They say the product's base contains pharmaceutical-grade aloe to counteract the potential for inflammation from glycolic acid and antioxidants and vitamins C, A and E to protect the skin from environmental damage. AloeGlyC products are available to skincare professionals. Home Laser. Palomar Medical Technologies Inc. recently announced that it would move the launch of its patented, home-use laser for the treatment of periorbital wrinkles to the Spring of 2011. The device is the only laser with over-the-counter clearance from the FDA for the treatment of periorbital wrinkles. OTC clearance allows the laser to be marketed and sold directly to consumers without a prescription. October 2010 | Practical Dermatology | 47 Therapeutics Update Product News Targeting Psoriasis at Home. Personal Targeted Phototherapy for psoriasis is now available from Levia, an at-home (or in-office) therapeutic device from Lerner Medical Devices. Levia, a new class of UVB medical device, is a safe and effective non-drug option for the self-treatment of scalp and small area psoriasis. It incorporates two proprietary beam delivery attachments, the LiteBrush and LiteSpot, which ensure precise and safe delivery of therapeutic UV light. For more information, visit www.mylevia.com. Opal Updated. An update to a 15-year-old fade gel, the new Black Opal Fade Systems are intended to treat Patient treated with Black Opal Fade System hyperpigmentation and reactive skin. The highest concentration of hydroquinone available OTC is combined with Citrus and Lotus Extracts in the BioIntensive Skin Complex to even tone and provide skin brightness. The new Black Opal Fade Collection includes Advanced Dual Complex Fade Gel Maximum Strength or Sensitive Skin Formula, Body Fade Crème Maximum Strength or Sensitive Skin Formula, and Daily Fade Creme SPF 15 Maximum Strength or Sensitive Skin Formula. Products retail for $12.95 to $15.95. ■ Advertising Index October 2010 Advertiser. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Page Allergan,Inc. www.allergan.com/site/skin Aczone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51-52 Astellas Pharma www.astellas.com . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 Coria Laboratories www.corialabs.com Atralin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19-20 Refissa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-8 FDAACTIONS Cosmetic Surgery Forum www.cosmeticsurgeryforum.com/ . . . . . . . . . . . . . . . . . .49 Ipilimumab Accepted for Review. FDA recently accepted for filing and review the Biologics License Application for ipilimumab (Bristol-Myers Squibb) for the treatment of adult patients with advanced melanoma who have been previously treated. Ipilimumab is a novel T-cell potentiator that specifically blocks the inhibitory signal of CTLA-4, a molecule that plays a critical role in regulating natural immune responses. The filing is based on results from the primary analysis of the pivotal MDX010-020 trial, which were published online in the New England Journal of Medicine and presented at the American Society of Clinical Oncology in June. The study compared the overall survival rate of patients who received ipilimumab plus the gp100 vaccine (3 mg/kg and 1 mg/kg every three weeks for four doses), ipilimumab alone (3 mg/kg every three weeks for four doses), and the control therapy of gp100 alone. Based on the FDA’s sixmonth goal for completing priority reviews, the projected FDA action date is December 25, 2010. Galderma www.galdermausa.com Psoriasis Pro . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42 48 | Practical Dermatology | October 2010 Ortho Dermatologics www.orthodermatologics.com Retin-A Micro . . . . . . . . . . . . . . . . . . . . . . . . . .2-3, 33 Stiefel a GSK Company www.stiefel.com Altabax . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27-28 Duac . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-12 Winter Clinical Dermatology Conference www.clinicaldermconf.org/ . . . . . . . . . . . . . . . . . . . . . . .41 For advertising inquiries please contact : Alan Guralnick, Group Publisher [email protected] • 484-581-1832 Ali Kinnie, Publisher [email protected] • 917-589-4160