Status:
COMPLETED
Safety and Efficacy of Luliconazole Solution, 10% in Subjects With Mild to Moderate Onychomycosis
Lead Sponsor:
Topica Pharmaceuticals
Conditions:
Distal and Lateral Subungual Onychomycosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT01431820
Start Date
May 1 2012
End Date
August 1 2014
Last Update
November 30 2015
Active Locations (28)
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1
Phoenix, Arizona, United States, 85050
2
Los Angeles, California, United States, 90045
3
San Diego, California, United States, 92119
4
San Diego, California, United States, 92123