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FDA approves luliconazole for tinea pedis

This article was updated November 25, 2013 to correct an error in treatment duration. 

The Food and Drug Administration has approved luliconazole (Luzu Cream, 1 percent, Valeant Pharmaceuticals) for the two-week, once-daily treatment of interdigital tinea pedis, tinea cruris, and tinea corporis, caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients ages 18 and older.

Luzu has undergone three positive pivotal studies in the United States that were the basis for approval, according to a news release. The studies were conducted in 679 patients who had either tinea pedis or tinea cruris.

For the two studies in tinea pedis with a treatment duration of two weeks, the primary endpoint was defined as complete clearance at four weeks post-treatment, meaning patients’ skin showed no clinical involvement and no evidence of fungus.

In study 1, 26 percent of patients treated with luliconazole demonstrated complete clearance, compared to 2 percent of patients treated with vehicle. In study 2, 14 percent of patients treated with luliconazole were completely cleared, compared to 3 percent of patients treated with vehicle.

For the study in tinea cruris, complete clearance was assessed at three weeks post-treatment. After one week of treatment, 21 percent of patients treated with luliconazole were completely cleared, compared to 4 percent of those treated with vehicle.

Application site reactions — the most common adverse events — were reported in less than 1 percent of patients for both luliconazole and vehicle.

All other approved treatments for these skin conditions require two weeks of treatment, according to the company. Luliconazole has been approved in Japan since 2005.

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