MedEsthetics magazines offers business education and in-depth coverage of the latest noninvasive cosmetic procedures for physicians and practice managers working in the medical aesthetics industry.
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EDITOR'S NOTE EDITORIAL ADVISORY BOARD Botox Approved for Crow's Feet The most requested product in aesthetic medicine has received FDA approval for one of its most common off-label indications. Allergan (allergan.com) announced in September that it has received FDA approval for Botox Cosmetic in the treatment of lateral canthal lines or crow's feet. Steven Dayan, MD, of Denova Research, Chicago, was the lead investigator on two clinical trials that were held in more than 20 facilities across the country and included healthy adults (18 to 65 years of age) with moderate-to-severe lateral canthal lines. The patients were Inga Hansen Executive Editor/Associate Publisher randomly assigned to receive either Botox Cosmetic (N=833) or placebo (N=529). In the first study, investigators assessed treatment of canthal lines alone; In study 2, they assessed simultaneous treatment of the canthal lines and glabella. In both studies subjects treated with Botox showed greater improvement than those who received a placebo. To establish efficacy, the company needed to show a two-grade improvement on the Facial Wrinkle Scale. The patients were treated with 12 units of toxin, and their lateral canthal lines were observed when smiling at baseline and 30 days following treatment. The most common adverse reaction in the treatment group was eyelid edema. In a release following the approval, the FDA notes that "Botox and Botox Cosmetic have a boxed warning that says the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. But there has not been a confirmed serious case of toxin spread when Botox or Botox Cosmetic has been used at the recommended dose for the approved indications." "Botox Cosmetic has a long safety history in the glabella area. This approval further solidifies the safety and efficacy of the treatment," says Dr. Dayan. Though physicians have been using Botox Cosmetic off-label for the treatment of crow's feet for years, he notes that FDA approval of the procedure "will increase awareness of the safety of treatment in this area." The off-label use of injectables and devices is widespread in the medical aesthetic industry. As physicians work with new products and technologies, they often discover new applications for FDA-approved products. In order to safely expand indications, however, it is imperative that physicians stay up-to-date on the latest research and anecdotal evidence coming in from their colleagues. Dermal fillers have now surpassed botulinum toxins in terms of growth in popularity among consumers, and their indications are expanding rapidly as well. One page 26, dermatologists and plastic surgeons share their experiences with the use of dermal fillers for localized wrinkles, tear troughs, the lips and volume replacement in the face. Fractional resurfacing is another area that has seen rapid growth in terms of both technologies and indications. On page 34, writer Linda W. Lewis offers a review of the different modalities now being used to fractionally resurface aging skin and highlights some of the key differences between the fractional devices now available. As we say goodbye to 2013, we look forward to seeing you at the upcoming 2014 meetings and learning more about how physicians are utilizing the latest tools to offer their patients the best—and safest—outcomes. ihansen@creativeage.com • 603.354.3291 2 NOVEMBER/DECEMBER 2013 | MedEsthetics Mary Lee Amerian, MD Santa Monica Laser and Skin Care Center, Santa Monica, CA Saul R. Berger, MD Medical Director, New Age Aesthetics, Encino, CA Padraic Deighan, MBA, JD, PhD Vail, CO Michael H. Gold, MD Assistant Clinical Professor, Vanderbilt University Medical Center Founder, Gold Skin Care Center, Nashville, TN Bruce Katz, MD Clinical Professor Dermatology, The Mount Sinai School of Medicine Director, Juva Skin & Laser Center, New York Lorrie Klein, MD Assistant Clinical Professor, University of California-Irvine Medical School Founder, LK Dermatology & Laser Center Euro Day Spas, Laguna Niguel, CA Allan Share President, International Medical Spa Association, Minnetonka, MN David H. McDaniel, MD Assistant Professor of Clinical Dermatology and Plastic Surgery, Eastern Virginia Medical School Director, The Institute of Anti-Aging Research, Virginia, Virginia Beach, VA Vic Narurkar, MD Associate Clinical Professor of Dermatology, UC Davis Medical School Chief of Dermatology, California Pacific Medical Center, San Francisco Ava Shamban, MD Laser Institute for Dermatology and European Skin Care, Santa Monica, CA Hema Sundaram, MD Director, Dermatology, Cosmetic & Laser Surgery Rockville, MD and Fairfax, VA Wm. Philip Werschler, MD Spokane Dermatology Clinic and Aesthetic Image Medical Spa, Spokane, WA