Safety and Efficacy of Luliconazole Solution, 10% in Subjects With Mild to Moderate Onychomycosis

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and efficacy of a topical antifungal formulation, Luliconazole Solution, 10%, in the treatment of adults with onychomycosis of the toenails.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Topica Pharmaceuticals
• Treatments: Luliconazole; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Subjects of either gender, any race and between the ages of 18 and 70 inclusive

• Subjects with a clinical diagnosis with culture confirmation of distal subungual onychomycosis (DSO) - Subjects must be free of any disease that in the Investigator's opinion might interfere with the study evaluations or jeopardize the subject's safety

Exclusion Criteria:

• Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the solution

• Subjects who are currently participating or have recently participated in another investigational medication or device study