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Therapeutics Update
PRODUCT NEWS
New Psoriasis Formulation Launched. Featuring a familiar active ingredient, Zithranol RR (Elorac) is a steroid-free cream featuring rapid release microcrystalline encapsulated anthralin, 1.2%. According to the company, which just launched the product, Zithranol reduces the risk of staining and irritation associated with traditional formulations of anthralin. Lipid technology is used to deliver the active agent, releasing the anthralin as the body's heat dissolves the encapsulation. It is approved for once-daily, short-contact therapy and is available by prescription only.
Building the Barrier. Helping to visibly improve the appearance of scarring, Kinerase's new Scar Healing Therapy softens, flattens, and smooth scars and also helps to normalize collagen deposition, the company says. Ingredients include cyclopentasiloxane, dimethicone, phenyl trimethicone, polysilicone-1, and polymethylisilesquioxane, and according to the company can improve the appearance of new or old scars in eight weeks.
Moisturizing Therapy. Winter, along with the drying effects of artificial heat, is just around the corner. For patients affected by dry skin, Vaseline has introduced Vaseline Clinical Therapy Body Lotion, described as an over-the-counter prescription-strength moisturizer. In a clinical study reported by the marketer, Clinical Therapy Body Lotion was shown to reduce itching by up to 64 percent and provide protection against severely dry skin even three days post application. In addition, 87 percent of patients reported a significant reduction in itching, while 88 percent of patients with dry skin reported positive skin improvements after two weeks of use of the lotion.
Radiesse Kit Released. BioForm Medical last month announced FDA approval of a process to mix Radiesse with lidocaine in order to enhance patient comfort. The company has since introduced a mixing kit, including a male-to-female/female-to-mail coupler that enables the mixture of syringe contents.
FDA ACTIONS
New Indication for Sculptra. With the addition of "Aesthetic" to its brand name, injectable poly-L-lactic acid (Sculptra Aesthetic, Sanofi-Aventis US) is now approved for use in immune-competent people to correct shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern injection technique is appropriate. The approval was based on data from a randomized, comparative, evaluator-blinded, parallel-group, multicenter study showing that use of the product yielded greater improvements in wrinkle correction at 13 months compared with human-derived collagen, as determined by wrinkle assessment scores. During the extension-phase study, patients initially treated with injectable poly-L-lactic acid continued to demonstrate gradual improvements in wrinkle assessment scores; benefits were maintained for up to 25 months after completion of therapy compared with three months for patients treated with human-derived collagen.
Skin Cancer Detector Moves Forward. FDA formally accepted for filing Electro-Optical Sciences, Inc.'s Pre-Market Approval (PMA) application for MelaFind, a non-invasive and objective computer vision system intended to aid in the early detection of melanoma. The FDA's action means that the PMA application was sufficiently complete and ready for substantive review. FDA also confirmed that the PMA application will receive expedited review and processing.
Combo Cream for Herpes Labialis Released. A new cream formulation featuring hydrocortisone plus acyclovir (Lipsovir, Medivir AB) received approval for the early treatment of recurrent herpes labialis to reduce the likelihood of ulcerative cold sores and to shorten lesion healing time. Treatment is approved for adults and children 12 and older. The approval was based on data from a clinical phase III trial showing that 42 percent of patients using hydrocortisone/acyclovir cream did not develop cold sores with blisters, ulcers, and crusting compared with 26 percent of those receiving placebo. For those patients who developed cold sores while using the combination cream, healing time was significantly decreased by 1.5 days compared to controls.
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