The Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of topical application of IDP-108 versus vehicle in treating patients with onychomycosis.

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

Details

• Lead Sponsor: Dow Pharmaceutical Sciences

Criteria

Inclusion Criteria:

• Clinically diagnosed onychomycosis of the target nail

• Presence of mild to moderate onychomycosis, defined as 20 - 50% of the area of the target nail being clinically affected

• Has a positive KOH examination from the target nail

• Has a positive dermatophyte culture from the target nail

Exclusion Criteria:

• Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug

• Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis

• Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit

• Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period