Overview

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