Safety and Efficacy of Luliconazole Solution, 10% in Subjects With Mild to Moderate Onychomycosis
Phase 2
Completed
- Conditions
- Distal and Lateral Subungual Onychomycosis
- Interventions
- Drug: Vehicle Solution
- Registration Number
- NCT01431820
- Lead Sponsor
- Topica Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 334
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Luliconazole Solution, 10% Regimen 1 Luliconazole Solution, 10% - Luliconazole Solution, 10% Regimen 2 Luliconazole Solution, 10% - Vehicle Solution Regimen 1 Vehicle Solution - Vehicle Solution Regimen 2 Vehicle Solution -
- Primary Outcome Measures
Name Time Method The proportion of subjects who achieve complete cure of the target great toenail Week 52
- Secondary Outcome Measures
Name Time Method