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FDA Approves New Drug for Tinea Corporis

The FDA recently approved a new drug application to treat tinea corporis, tinea cruris, and tinea pedis. The drug is luliconazole, a topical azole antifungal cream.

Luliconazole is approved for a 1-week, once-daily treatment regimen treatment course in adults over 18 years old with tinea corporis or tinea cruris. Treatment for interdigital tinea pedis is once daily for 2 weeks. 

FDA approval followed on the heels of three studies consisting of 679 patients with tinea pedis or tinea cruris.  Two of the studies looked at tinea pedis. Treatment was administered for a duration of 2 weeks and primary endpoint was defined as complete clearance at 4-weeks post-treatment. Twenty-six percent and 14% of participants achieved complete clearance with luliconazole in the studies, respectively, compared to only 2 – 3% of participants who were treated with vehicle.

The third study defined complete clearing of tinea cruris at 3 weeks post treatment. Twenty-one percent of participants displayed complete clearance as opposed to only 4% of participants treated with vehicle.

FDA approval of luliconazole gives health care providers another option for treating tinea corporis, tinea cruris, and tinea pedis. 

 

Sources: 1, 2

Image: Matthew T Rader




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