FDA Approvals and NewsFraxel Laser Approved to Treat Acne and Surgical ScarsReliant Technologies announced that it has received FDA clearance to market a new indication for its Fraxel Laser, enabling physicians to treat acne scars and surgical scars. Approval was based on a study led by Zakia Rahman, M.D., Clinical Instructor of Dermatology at Stanford University in Palo Alto, CA, and Medical Director of the Fraxel Laser Clinic in Mountain View, CA.The study enrolled 40 subjects who had 53 scars that were treated with the Fraxel laser. Clinical outcomes were reviewed after three to five treatments at 1- and 3-month follow-ups. Independent investigator evaluation indicated that 92% of all subjects treated sustained statistically significant improvement in overall scar severity at the 3-month follow-up visit. Treatments were safe and well tolerated with no serious adverse events observed. The Fraxel laser provides a comprehensive treatment approach that gently repairs the epidermal abnormalities and also reaches deep into the dermis to induce new collagen formation without compromising patient safety. EpiCeram Granted 510k Clearance Ceragenix Pharmaceuticals, Inc., announced it has received 510K clearance from the FDA for its EpiCeram Skin Barrier Emulsion to improve dry skin conditions and relieve and manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions by maintaining a moist wound and skin environment. This topical, non-steroidal treatment that consists of a specific combination of lipids will be available by prescription only. Palomar Receives FDA Clearance for New HandpiecePalomar’s LuxIR Fractional Infrared Handpiece, and attachment for the StarLux Pulsed Light and Laser System, recently received FDA clearance for coagulation of soft tissue for dermatological procedures. It already had clearance for deep heating for pain relief. The LuxIR handpiece delivers infrared light into the dermis and hypodermis with the light contracting the skin through soft tissue coagulation, resulting in overall skin tightening, according to the company. The LuxIR Fractional Infrared Handpiece delivers energy as a regular array of small beams ranging from 1.5 mm to 3 mm within the deep dermis. This delivery method creates a lattice of highly affected areas surrounded by less affected areas. First Head and Neck Cancer Treatment Cleared in 45 Years The FDA announced the approval of cetuximab (Erbitux) for use in combination with radiation therapy to treat patients with squamous cell cancer (SCC) of the head and neck that cannot be removed by surgery. This is the first drug approved for head and neck cancer that has shown a survival benefit in this population.Erbitux was also approved for use as a monotherapy to treat patients whose head and neck cancer has metastasized despite the use of standard chemotherapy. Approval of Erbitux, the first drug approved to treat head and neck cancer since methotrexate became available in the 1950s, in combination with radiation therapy was based on a study that showed it prolonged survival by 20 months compared to treatment with radiation alone. Approval of Erbitux monotherapy was based on evidence of tumor shrinkage in 13% of patients, lasting an average of 6 months. Safety and effectiveness of the drug was established in two studies. A randomized clinical trial of 424 patients using Erbitux in combination with radiation therapy showed a survival time of 49 months versus 29.3 months on radiation therapy alone. Delay in tumor growth was observed with the combination treatment, compared to radiation alone. A second trial of 103 patients with recurrent or metastatic SCC of the head and neck showed Erbitux helped to shrink tumors after the tumors no longer responded to platinum-based therapy, the current standard treatment for this disease. Skin & Aging News Are Sunscreen Labels Misleading?Several coordinated lawsuits were filed in California Superior Court in Los Angeles on March 29, accusing several sunscreen manufacturers of lying about the effectivness of their products in blocking sun rays and preventing skin diseases, including cancer. The complaint charges that some products marketed as protective “sunblocks” are unreliable in protecting adults and children and can create a sense of false security that actually endangers users. Two law firms are litigating coordinated class actions, alleging systematic fraud, false advertising and persistently misleading claims that exaggerate the ability of sunscreens to protect against the sun and reduce the risk of cancer and other skin ailments. The suits claim that manufacturers are making fraudulent and misleading claims on labels, Web sites and in advertising and seek an injunction on the claims, compensation for consumers and other remedies, including an industry-funded public education program on sun protection. The seven defendants and their five brands named in the suits include Schering Plough (Coppertone), Sun Pharmaceuticals and Playtex Products (Banana Boat); Tanning Research Laboratories (Hawaiian Tropic), Neutrogena Corp., and Johnson & Johnson (Neutrogena); and Chattem, Inc., (Bullfrog).The AAD’s Stance on the IssueJust 2 days after the suits were filed, the American Academy of Dermatology (AAD) released a statement reaffirming its position that sunscreen is beneficial when used regularly and properly and in conjunction with wearing protective clothing and seeking shade. “Scientific evidence supports the beneficial effects of proper sunscreen usage,” Stephen P. Stone, M.D., President of the AAD, said in the statment. “While it is an important tool in the fight against skin cancer, sunscreen alone does not protect you enough. People shouldn’t feel they can stay in the sun for extended periods of time just because they are wearing sunscreen.”“While health issues are complex and involve multiple factors, we know that ultraviolet (UV) rays are the primary cause of skin cancer and the solution is to avoid excessive exposure to the sun and other forms of UV radiation,” stated Dr. Stone. “In fact, the United States Department of Health & Human Services declared UV radiation from the sun and artificial sources as a carcinogen in 2002.” New Acne and Rosacea SocietyA dedicated, varied group of dermatologists met recently at the American Academy of Dermatology annual meeting with a singular focus: elevating the understanding and treatment of acne and rosacea.Gathering for the first time, members of the newly established American Acne & Rosacea Society (AARS) met to discuss the group’s goals and objectives and to hear an entertaining keynote address from renowned dermatologist Albert Kligman, M.D., Ph.D.According to AARS President Guy Webster, M.D., Ph.D., “AARS was formed to promote research and education on the biology and treatment of acne. Although acne and rosacea are common diseases that make up a large part of daily dermatologic practice, the academic community pays little attention to them. “We aim to correct this imbalance by encouraging investigation and developing young investigators. Educational programs will be created to aid in resident training, and our meetings will provide a forum for presenting the latest research.”In addition to Dr. Webster, other Executive Committee members include President-Elect Hilary Baldwin, M.D., and Lee Zane, M.D., who is s Secretary-Treasurer. Founding Society Chairmen include Dr. Kligman, as well as Dr. John Strauss, Dr. Peter Pochi, Dr. Alan Shalita and Dr. Jim Leyden. The list of Founding Directors is equally impressive and includes the following: Diane Berson, M.D., David Cohen, M.D., James Q. Del Rosso, D.O., Lawrence Eichenfield, M.D., Julie Harper, M.D., Mark Jackson, M.D., Sewon Kang, M.D., Anne Lucky, M.D., Leonard Swinyer, M.D., and Diane Thiboutot, M.D.If you’re interested in learning more about this group or joining the AARS, contact Dr. Baldwin at hbaldwin@downstate.edu.The AARS has not yet set a date for its next meeting; however, this enthusiastic group is sure to have a lasting impact.“Our inaugural meeting was a happy collision of veteran researchers and young acne specialists, a sort of hybrid of the All-Star Game and the Hall of Fame all at once,” says Dr. Webster. “With such a group assembled I expect great things to happen!” Preventing Skin Cancer & MelanomaThe American Academy of Dermatology (AAD) is celebrating Melanoma/Skin Cancer Detection and Prevention Month in May by coordinating several activities to raise awareness about skin cancer and sun-safe behaviors.The AAD will host several free screenings for skin cancer throughout the country.Also, this month the AAD has teamed up again with Major League Baseball and the Major League Baseball Players Association to continue the Play Smart When It Comes to the Sun Program to raise skin cancer awareness among baseball players and fans. The AAD also runs Make Sun Safety Your Goal! — a public education program designed to raise awareness with soccer players and their fans through a public service partnership among the AAD, Major League Soccer, the U.S. Soccer Foundation and the Environmental Protection Agency. Applications are available for the AAD’s Shade Structure Program, which is supported by a grant from Johnson & Johnson Consumer Products Companies. The grants are available to community-based, non-profit organizations in need of shade for an outdoor location. Applicants must demonstrate a commitment to sun safety and have their application sponsored by an AAD member. Visit www.aad.org for applications and additional information.