Clinical Trials Resource Center

Athlete's Foot (Tinea Pedis)

October 12, 2009

Topica Pharmaceuticals issued positive results from a phase II trial of luliconazole for the treatment of tinea pedis (athlete's foot). This multi-center, randomized, double blind, trial evaluated the safety and efficacy of 1% luliconazole cream administered once daily for 14 or 28 days in patients with moderate to severe tinea pedis. The primary endpoint was the proportion of subjects who achieved complete clearance at 2 weeks post-treatment. At day 42, the 14-day dose resulted in a 53.7% complete clearance rate compared with a placebo rate of 4.5% (p≡0.0001) and the 28-day dose resulted in a 45.7% complete clearance rate compared with a placebo rate of 10% (p≡0.0071). There was no statistical difference in complete clearance between the 14 or 28 day once daily dosing regimen (p≡0.4928). The mycologic results also improved over time post treatment. The 14-day dose resulted in a 78% mycologic cure at day 28 and 82.9% at day 42. No serious or drug-related adverse events were reported.

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