The primary endpoint was stringently defined as the complete cure rate at Week 52, which means that the target nail showed no clinical involvement and no evidence of fungus present by both KOH testing and by a negative fungal culture.In both studies, the primary endpoint of complete cure was statistically significant ( P < .001) in favor of efinaconazole topical solution 10%. In Study 1, 17.8% of subjects treated with efinaconazole were completely cured compared to only 3.3% of subjects treated with vehicle. In Study 2, 15.2% of subjects treated with efinaconazole were completely cured compared to only 5.5% of subjects treated with vehicle. Although no head-to-head studies have been conducted, these results are comparable to that reported with oral treatment of onychomycosis.
Valeant Pharmaceuticals Announces Publication Of Efinaconazole Phase III Results
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