FDA Approvals & NewsOracea Approved for RosaceaThe first orally administered and systemically delivered drug for the treatment of rosacea has now been granted FDA approval. Oracea, from CollaGenex Pharmaceuticals, is indicated for the treatment of inflammatory lesions of rosacea in adults. The approval for this once-a-day treatment is based on results from two Phase III, double-blind, placebo-controlled studies that reported on data from 537 patients in 28 U.S. centers. Patients in these studies who received Oracea experienced statistically significant (p<0.001) results that included a 61% and 46% mean reduction in inflammatory lesions compared with 29% and 20% mean reduction in those receiving placebo. In addition, the drug’s side effect profile was similar to placebo.Oracea, which will be available in a 40-mg capsule, will launch this July. CollaGenex is also conducting a Phase II clinical trial to determine optimum dosing for its second potential dermatology drug, incyclinide, which will be for the treatment of acne. The company also has a preclinical compound for the treatment of redness associated with rosacea and other skin disorders under study. New Hyaluronic Acid Filler ApprovedThe FDA has granted approval to Allergan’s Juvéderm, touted as a next-generation hyaluronic acid filler. Juvéderm has the highest concentration of cross-linked hyaluronic acid of any FDA-approved dermal filler, which effectively increases the longevity of results patients attain with this filler agent. FDA approval was based on data from a double-blind, randomized and controlled clinical trial that compared Juvéderm to the bovine-based collagen agent Zyplast. In this 6-month trial, a total of 439 people were injected with either one of three formulations of Juvéderm that included the following:1. Juvéderm 24HV (highly cross-linked and formulated for more versatility in contouring and volumizing facial wrinkles and folds)2. Juvéderm 30HV (more highly cross-linked and better for correcting deeper wrinkles and folds)3. Juvéderm 30 (highly cross-linked and formulated for subtle corrections of facial wrinkles and folds).Study participants received Juvéderm in one nasolabial fold and Zyplast in the other. Over the 6-month study, 90% of participants maintained at least a 1-grade improvement in nasolabial fold correction in the Juvéderm side vs. 36% to 45% in the Zyplast-corrected side. Juvéderm is also the only “approved hyaluronic acid dermal filler that has demonstrated its safety and effectiveness in patients of all skin types and colors,” Allergan reported. In clinical trials of non-Caucasian patients, patients experienced no increased risk of hyperpigmentation or hypertrophic scarring.  Extended-Release Minocycline TabletThe FDA has approved Solodyn Extended Release Tablets (minocycline HCl) as a once-a-day treatment for inflammatory lesions and non-nodular moderate to severe acne vulgaris in patients who are 12 years of age or older. This formulation is the only approved minocycline extended-release tablet. Approval was based on multi-year clinical trials of more than 1,000 patients. According to Medicis, sponsor of the trials, patients did not benefit therapeutically from doses of minocycline that were above the recommended 1 mg/kg daily. In fact, higher doses were associated with more acute vestibular side effects.  S&A News & TrendsNatural Fighter of MRSAA new antimicrobial compound produced by a bacterium has the ability to effectively fight methicillin-resistant Staphylococcus aureus (MRSA) infections, reported the May issue of the journal Nature, according to Reuters Health.The bacterium Streptomyces platensis helps form the antibiotic platensimycin, which has been studied in the lab and in animals. In mice treated with platensimycin, which has no known toxicities, infections caused by S. aureus were effectively eliminated. Platensimycin works by “blocking microbes’ ability to synthesize lipids,” according to Reuters, and the antibiotic has demonstrated broad-spectrum activity against multiple microbes. Researchers discovered the antibiotic after screening 250,000 natural products. Top Skin AllergensMayo clinic dermatologists tested more than 1,500 patients with a series of up to 73 allergens to determine the top causes of skin allergies. Results of the study, led by Mark D. P. David, M.D., were announced at the American Academy of Dermatology’s annual meeting. According to the study, the top 10 skin allergens were:• Nickel (nickel sulfate hexahydrate). This metal is commonly found in jewelry, clasps and buttons.• Gold (gold sodium thiosulfate). The precious metal is often found in jewelry.• Balsam of Peru (myroxylon pereirae). This fragrance is used in many perfumes and skin lotions.• Thimerosol. This mercury compound is used in local antiseptics and as a preservative in some vaccines.• Neomycin sulfate. A topical antibiotic that is used in first-aid creams and ointments and in some cosmetic products.• Fragrance mix. This is a group of eight of the most common fragrance allergens found in foods, cosmetic products, insecticides, perfumes, dental products., etc.• Formaldehyde. This preservative is found in paper products, paints, medications, cleansers, cosmetic products and fabric finishes. • Cobalt chloride. This metal is found in medical products, hair dye and objects plated with metal.• Bacitracin. This is a topical antibiotic.• Quaternium 15. A preservative that is used in many cosmetic and industrial products.For more information on many of these allergens, read Skin & Aging’s “Allergen Focus” column each month. This month, columnist Dr. Sharon Jacob focuses on gold on page 16. Also, go to skinandaging.com and visit our archives to read past “Allergen Focus” columns in which many of the top-10 allergens mentioned above have already been covered in-depth.  In Brief...The National Rosacea Society Announced…that new grants are available in 2006 to support research into the potential causes and other key aspects of rosacea. Earlier this year, five new studies were awarded funding, totaling $123,600, as part of its research grants program to advance scientific knowledge of rosacea. Researchers interested in applying for grants should call (847) 382-8971 or e-mail rosaceas@aol.com.DUSA Pharmaceuticals Announced…the hiring of William F. O'Dell as Executive Vice President, Sales and Marketing. Mr. O'Dell has more than 30 years experience in the pharmaceutical and medical device industries. Taro Pharmaceutical Industries Ltd., Reported…that it has entered into an agreement with Alkem Laboratories Ltd., under which the companies will develop products jointly for the United States and other markets. Details of the agreement have not been disclosed.DermAvance Pharmaceuticals, Inc. Announced… the appointment of Keith A. Greathouse as President and Chief Executive Officer. The privately held specialty dermatology pharmaceutical company also announced the launch of its first products including Vivelif (acetyl hexapeptide-3), a topical therapy designed to treat the visible signs of aging.