TOPICA Pharmaceuticals, a privately-held biotechnology company, today announced positive results from its Phase 2 clinical study evaluating luliconazole, one of the most potent and broad spectrum topical antifungal agents, in patients with tinea pedis (athlete's foot). The study was designed to assess the effectiveness of 1% luliconazole cream applied once daily for 14 days compared with once daily for 28 days. The study met its primary efficacy endpoint demonstrating that luliconazole, when applied once daily for 14 days, was able to achieve "complete clearance," as evaluated by a clear clinical score and negative mycology assessment (negative fungal culture and negative potassium hydroxide (KOH) test) equivalent to the 28-day dosing regimen.
"These Phase 2 results suggest that luliconazole may be able to treat tinea pedis in half the time, compared with commonly prescribed products in the U.S., which require treatment once or twice a day for four weeks. For tinea pedis patients, these results may translate to a significantly easier treatment plan to follow, which should improve clinical outcomes. It is impressive to see that even four weeks after treatment ends with luliconazole, its antifungal effects continued to persist," said Terry M. Jones, M.D., a board certified dermatologist and leading enroller in the phase 2 trial.
The multi-center, randomized, double blind, trial evaluated the safety and optimal duration of 1% luliconazole cream administered once daily for 14 or 28 days in patients with moderate to severe tinea pedis. The Phase 2 results demonstrated: