Efficacy and Safety of AN2690 Topical Solution to Treat Onychomycosis of the Toenail

• Drug: AN2690 Topical Solution, 5%
  
  AN2690 Topical Solution, 5%, applied once daily for 48 weeks
• Drug: Solution Vehicle
  
  AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks

• Experimental: AN2690 Topical Solution, 5%
  
  AN2690 Topical Solution, 5%
  Intervention: Drug: AN2690 Topical Solution, 5%
• Placebo Comparator: Solution Vehicle
  
  Solution Vehicle
  Intervention: Drug: Solution Vehicle

Inclusion Criteria:

• Clinical diagnosis of distal subungual onychomycosis affecting at least one great toenail
• KOH positive at screening
• Willingness not to use any other products including nail polish applied to the toenails during the study
• Women of childbearing potential who are currently sexually active must agree to use contraception for the entire study period

Exclusion Criteria:

• Concurrent or recent use of certain topical or systemic medications without a sufficient washout period
• History of any significant chronic fungal disease other than onychomycosis
• Significant confounding conditions as assessed by study doctor
• Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
• Pregnancy or lactation