Safety & Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails

A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study of the Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenails for 52 Wks

The objectives of this study are to assess the safety of NAB001 for topical treatment of mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.

Inclusion Criteria:

• mild to moderate fungal infection of the toenail as assessed by study doctor
• koh positive & dermatophyte culture positive at Visit 1
• good general health as assessed by the study doctor

Exclusion Criteria:

• severe fungal toenail infection
• prior use of antifungal drugs (wash-out allowed, duration varies on class)
• significant confounding conditions as assessed by study doctor
• pregnancy/lactation
• must forego nail salon procedures during study for at least ~60 weeks