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

A Randomized, Double-Blind, Vehicle-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of AN2690 Topical Solution, 5%, vs. Solution Vehicle in the Treatment of Onychomycosis of the Toenail in Adults

The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.

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