- 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
- 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