FDA Approvals & NewsRemicade Approved for PsoriasisThe anti-TNF-alpha treatment infliximab (Remicade) has received FDA approval for the treatment of adult patients with chronic severe plaque psoriasis. Specifically, according to Centocor, the drug’s manufacturer, the indication is for patients who are candidates for systemic therapy when other systemic therapies are medically less appropriate.Delivered intravenously at a doctor’s office or clinic, Remicade is infused over a 2-hour period at a dosage of 5 mg/kg for psoriasis. Early in therapy, this treatment is administered at the patient’s initial visit and then at 2 weeks and 6 weeks. Afterward, patients receive treatment at 8-week intervals. FDA approval was based on data from two Phase III studies, EXPRESS and EXPRESS II, that included more than 1,200 patients. The data are as follows:EXPRESS. In this study, 8 out of 10 patients experienced a 75% improvement in their psoriasis as measured by the Psoriasis Area Severity Index (PASI 75) by week 10.EXPRESS II. Patients in this study maintained PASI 75 when evaluated at every 8-week interval up to 6 months. According to study data, the majority of patients continued to achieve PASI 75 at week 50, which was the last visit for both studies. In addition to the newest indication for psoriasis, Remicade is also indicated for the treatment of psoriatic arthritis, rheumatoid arthritis, Crohn’s disease, both for adults and pediatric patients, ulcerative colitis and ankylosing spondylitis.  New Atopic Dermatitis Foam TreatmentThe FDA has approved a new treatment for atopic dermatitis. Desonide (Verdeso Foam 0.05%), a low-potency topical corticosteroid from Connetics, was approved for the treatment of mild-to-moderate atopic dermatitis.As the first product approved using the company’s propriety emulsion foam (VersaFoam-EF), Verdeso is also the first product approved for Connetics that’s indicated for the treatment of pediatric patients. Approval was based on data from a double-blind, randomized study of 581 patients aged 3 months to 17 years old. In the study, success was defined as an improvement in the five-point Investigator’s Static Global Assessment (ISGA) of two grades from baseline to week 4. Study data indicate that 39% (152) of the 387 patients who underwent treatment with Verdeso achieved success with this therapy as compared to only 9% (18) of the 194 patients who received the foam vehicle. Previously known as Desilux, Verdeso will be marketed to physicians in the fourth quarter of this year. The therapy will be available in 50-g and 100-g trade unit sizes.  Newly Approved Product for Highest Level UVA/UVB ProtectionThe FDA recently approved Anthelios SX with Mexoryl, which is an organic filter that offers high-level protection against short UVA waves. The approval of Mexoryl marks the first time since 1988 that the FDA has approved a new sunscreen filter. While other sunscreens offer protection against UVA rays, Mexoryl is formulated to protect against the short UVA wave spectrum that is not covered by other sun filters. Anthelios, which is made by LaRoche-Posy, is a moisturizing cream that combines other sun filters besides Mexoryl. These include Octocrylene and Avobenzone (photo-stabilized Parsol 1789). The sun filters work together to provide the most complete protection against UVB and UVA rays, according to La Roche Posay. In addition, Anthelios is formulated for even the most sensitive skin.  iPLEDGE: FDA Eliminates a Major HeadacheThe FDA and the iPLEDGE program have updated iPLEDGE to eliminate one of the most frustrating elements of the program to dermatologists — the 23-day lock-out period for males and females of non-child bearing potential. This change does not affect female patients of child-bearing potential. For the complete MedWatch Safety summary, log on to: http://internetdev/medwatch/safety/2006/safety06.htm#Isotretinoin.  New Indication for the Portrait P SR3The FDA has granted clearance to Rhytec’s Portrait Plasma Skin Regeneration (Portrait P SR3) system for use in treating non-facial rhytids. The Portrait delivers nitrogen plasma energy to accomplish skin resurfacing. With this treatment, the outer layers of the skin remain intact and provide a protective cover for the skin while it regenerates. When the skin underneath has healed, the protective layer peels away. The Portrait was first cleared in 2003 for the treatment of facial and non-facial areas for superficial skin lesions, actinic keratosis, seborrheic keratosis and viral papillomata. In 2005, the device was cleared for treatment of facial rhytids.  New Gel for Seborrheic DermatitisBarrier Therapeutics received FDA approval for ketoconazole (Xolegel Gel, 2%) for the treatment of seborrheic dermatitis in immunocompetent adults and children aged 12 years and older. This steroid-free, anti-fungal agent was previously referred to by the company as Sebazole. Xolegel is the first prescription gel formulation of ketoconazole approved in the United States. This treatment is prescribed for once-daily application for 2 weeks.  Drug News In Brief...• The first generic prednicarbate cream was approved by the FDA for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The reference drug is Dermatop.• The FDA has accepted a supplemental premarket application for Sculptra (poly-L-lactic acid) for facial cosmetic use.  News & TrendsCan a Tanning Cream Decrease Skin Cancer Risks?Scientists at the Dana-Farber Cancer Institute and Children’s Hospital in Boston say they have discovered a cream that may ward off skin cancer by tanning skin without exposure to sun. A study, which was published in the Sept. 21 issue of Nature, involved giving tans to specially engineered mice through application of a cream that switched on a “tanning mechanism” in their skin cells, not by exposing them to ultraviolet rays in sunlight. Because people who tan easily, or have naturally dark skin, are far less likely to develop skin cancer than fair-skinned individuals, researchers say the findings suggest that medicinally-induced tans can protect at-risk individuals from the disease. “The study involved using a small molecule to essentially mimic the process that occurs when skin cells are struck by ultraviolet light from the sun,” explained the study’s senior author, David E. Fisher, M.D., Ph.D., Director of the Melanoma Program at Dana-Farber and a Professor in pediatrics at Children’s Hospital Boston, in a press release. The mouse skin cells were genetically designed to resemble those in fair-skinned people, such as redheads. The compound used in the study has not yet been tested in humans, although researchers say that is the next step. The compound used in the study, called forskolin, is derived from the root of the forskohlii plant found in India. The mice involved in the experiment experienced darkened skin, proving that melanocytes in redheads aren’t inherently unable to make pigment if appropriately stimulated, according to researchers. Researchers also showed that tans acquired through forskolin offered protection against skin cancer caused by exposure to UV light. Researchers sill need to determine whether forskolin will penetrate deeply enough in human skin to activate melanocytes.More Research NeededJames Spencer, M.D., a dermatologist in private practice in St. Petersburg, FL, says the idea behind this research is interesting since melanin is “nature’s sunscreen”, and incidents of skin cancer in dark-skinned patients is very low. Dark-skinned people are born tan, and thus have protective melanin without having to expose their skin to carcinogenic UV light first. In contrast, fair-skinned people have little melanin naturally: They can expose their skin to carcinogenic UV light and make more melanin, but they have to damage their skin first. A true melanin tan is protective, so if there is a way to trick the skin into tanning without UV damage, the protection against melanoma would be great. This is not the first research of its kind, explains Dr. Spencer. Researchers at the University of Arizona came up with a derivative of melanocyte stimulating hormone to try to trick the body into tanning, and a company in Australia, Epitan, is trying to commercialize it. Dr. Barbara A. Gilchrest also studied how tanning happens when the body tries to excise and dispose of damaged genetic material, and in the process the skin erects a protective barrier that tries to stop sunlight from further destroying cellular DNA.“If somebody can perfect this and develop a product that’s safe and causes a true melanin tan, it would be protective,” says Dr. Spencer. However, he explains, the cream being researched currently is a long way from being a commercial product. Researchers need to determine if it’s safe and make sure that it doesn’t produce melanoma or moles or potentiate melanoma. In the long run, though, an artificial melanin tan would be protective and something consumers want since consumers are interested in cosmetic tans.