FDA Approvals & NewsOlux-E Approved to Treat Psoriasis and EczemaFDA granted approval for clobetasol propionate (Olux-E Foam, 0.05%) for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive psoriasis and eczema in patients aged 12 years and older. Clinical studies with Olux-E, which is the first super-high potency corticosteroid that is delivered in an emollient-based foam, were conducted in people with moderate to severe atopic dermatitis. During the studies, 251 people were treated twice daily for 2 weeks with Olux-E Foam and 126 subjects were treated with vehicle foam. At the end of treatment, 131 of 251 subjects (52%) treated with Olux-E Foam compared with 18 of 126 (14%) treated with vehicle foam achieved treatment success. Treatment success was defined by an Investigator’s Static Global Assessment (ISGA) score of clear (0) or almost clear (1) with at least 2 grades improvement from baseline, and scores of absent or minimal (0 or 1) for erythema and induration/papulation.In an additional randomized study of subjects 12 years of age and older with mild to moderate plaque type psoriasis, 253 subjects were treated with Olux-E Foam and 123 subjects were treated with vehicle foam. Subjects were treated twice daily for 2 weeks. At the end of treatment, 41 of 253 subjects (16%) treated with Olux-E Foam compared with 5 of 123 (4%) treated with vehicle foam achieved treatment success. Treatment success was defined by an Investigator’s Static Global Assessment (ISGA) score of clear (0) or almost clear (1) with at least 2 grades improvement from baseline, scores of none or faint/minimal (0 or 1) for erythema and scaling, and a score of none (0) for plaque thickness.Adverse events noted in the controlled clinical trials included a 1.9% incidence of application site atrophy and a 1.6% incidence of application site reaction.Treatment should be limited to 2 consecutive weeks, and patients should not use more than 50 g of Olux-E per week, according to Stiefel Laboratories.  Public Health Advisory on Topical AnestheticsThe FDA has issued a public health advisory to warn against the potential hazards of using topical anesthetics for cosmetic procedures. Last month, the FDA warned five firms to cease compounding topical anesthetic creams.The most recent advisory, however, recounts the cases of two women, aged 22 and 25, who had applied topical anesthetics at home, then wrapped their legs in plastic wrap and later died as a result of too much anesthetic causing seizure, coma and death. The advisory details other adverse events the FDA has received regarding reports of serious and life-threatening side effects documented from topical anesthetics, and it outlines some steps for consumers to take before using a topical anesthetic to ensure safety. For a copy of this public health advisory, log onto: www.fda.gov/cder/drug/advisory/topical_anesthetics.htm.  Hormone Approved to Treat AcneThe first and only oral contraceptive to be approved for three indications has received FDA approval to treat acne. The hormone YAZ (3 mg drospirenone/20 mcg ethinyl estradiol), which is manufactured by Berlex Inc., was approved for the indication of treating moderate acne vulgaris in women who desire an oral contraceptive for birth control. The approval was based on two, 6-month, multicenter, double-blind, placebo-controlled, randomized clinical trials of more than 1,000 patients. Treatment with YAZ resulted in statistically significant reductions in total inflammatory and non-inflammatory acne lesion counts. Patients who received treatment with YAZ in the trial, as compared to patients who received placebo, were four times more likely to attain investigator ratings of “clear” or “almost clear” using the Investigator’s Static Global Assessment scale.  SA News & TrendsPhoto Essay Brings Impact of Eczema to LifeThe national Eczema Association, celebrity photographer Jeremy Kost and Novartis Pharmaceuticals collaborated to product Images of Isolation, a photographic essay designed to visually bring to life the impact eczema has on the lives of patients living with the condition. The photographic essay, compiled as a full-color portfolio of patients’ pictures and stories, was published in October 2006 to coincide with National Eczema Awareness Month. All the photos were taken by Jeremy Kost, who is known for his unique Polaroid shots of A-list celebrities. Mr. Kost traveled to cities across the country to take the pictures of those living with eczema in their everyday lives. Inspiration for EssayInspiration for the photo essay came from the International Study of Life with Atopic Eczema (ISOLATE), a large study to assess the impact of atopic dermatitis (AD) on the lives of those living with it and how patients and caregivers mange the condition. The study comprised of interviews with 2,002 patients from eight countries over the age of 13 and caregivers of children between the ages of 2 to 13, with moderate to severe eczema. Questions were developed by national patient associations and physicians from countries included in the study. The study results showed:• On average, 55% of patients are either always or sometimes worried about the next eczema flare, and 51% are either always or sometimes unhappy/depressed.• 75% of caregivers and patients feel that being able to effectively control eczema would be the single most important improvement to their or their child’s quality of life.• On average, 43% of patients are fairly or very concerned about being seen in public during an eczema flare. • The most commonly affected parts of the body in patients during eczema flares were the face and neck, regardless of age, gender or severity.• On average patients take 2.5 days off school or work per year due to eczema and 9% of the time their concentration is affected at school or work while in flare.• 74% of patients and caregivers state that their physicians have never discussed the emotional aspect the eczema has had on their lives.Images of Isolation, according to the National Eczema Association, was designed to focus on the people who live with eczema in their daily lives, rather than on the skin condition. Each photo of a patient, also includes a story about his or her life. Visit www. nationaleczema.org.  Court Ruling Allows Doctors to Continue to Sell ProductsA recent ruling by the Washington Supreme Court overturned a 2002 decision that doctors could not profit from selling prescription medications to their patients, which was part of a criminal class action lawsuit against a physician by a group of patients who claimed the physician violated the anti-kickback provision of Washington’s Consumer Protection Act when he profited from selling fen-phen to patients. The recent ruling found that the 1949 Washington anti-kickback statute was meant to forbid illegal referrals or “unearned” profits from a third party, but not to prevent doctors from making money off the goods that they provide directly to patients, whether medications or medical equipment.According to an amednews.com Nov. 20, 2006 article, doctors praised the court’s decision. And, if the court had found against the doctor, doctors, pharmacists, hospitals and clinics in Washington that mark up the costs of medications or medical devices, such as crutches, may also be found guilty of committing a crime. The attorney for the plaintiff, on the other hand, says the statute was meant to protect patients from doctors’ conflicting business interests and prevent doctors from making money from the sale of drugs or other goods, according to the article, and that the court’s narrow interpretation of the law could make it difficult to enforce when it is abused.  In Brief...FriendlyLight Lasers Recently Executed… a new corporate identity plan. The developer, manufacturer, and marketer of unique air-cooled medical/aesthetic lasers is now Aerolase. In addition to the new name, the new plan will include product re-branding and a re-messaging of marketing materials.Iridex Corp. Announced the Appointment… of Meryl A. Rains as Chief Financial Officer. Ms. Rains replaces Larry Tannenbaum, who has been named the company’s first Chief Business Officer, responsible for overseeing the company’s corporate business development and the integration of the Laserscope aesthetics business, which was acquired in January. PhotoMedex, Inc. Announced… the launch of its new corporate Web site (www.photomedex.com). The site, which has been completely redesigned, contains new features such as a site search functionality and improved navigation. The redesigned site consolidates the corporate Web sites of Procyte (www.procyte.com) and Surgical Laser Technologies (www.slti.com) under the PhotoMedex umbrella to offer doctors, patients and investors a complete view of the company's offering in the areas of dermatology lasers, therapeutic skin, hair and wound care products and surgical products and services.Thermage, Inc. Announced… that it has entered into a strategic partnership with Radiance Medspa Franchise Group, a medical spa franchise, based in Scottsdale, AZ, with 44 franchises across the United States. Specific terms of the agreement were not disclosed.Electro-Optical Sciences, Inc. Announced… the initiation of a pivotal clinical trial for MelaFind, the company's non-invasive, point-of-care instrument to assist in the early diagnosis of melanoma. The MelaFind pivotal study will include up to 1,200 pigmented skin lesions, and at least 93 eligible melanomas for analysis. MelaFind features a hand-held imaging device that emits light of multiple wavelengths to capture images of suspicious pigmented skin lesions and extract data. Using algorithms, the data are then analyzed against a proprietary database of melanomas and benign lesions in order to provide information and produce a recommendation of whether the lesion should be biopsied.