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

• Status: Completed
• Trial end date: 2013-01-08
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Pharmaceutical Solutions; Tavaborole

Criteria

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