NCT01431820

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

Safety and Efficacy of Luliconazole Solution, 10% With Two Dosing Regimens in Distal Subungual Onychomycosis of the Toenails: A Randomized, Double-Blind, Vehicle-Controlled, Phase 2B/3 Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 334 (actual)
• Sponsor: Topica Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Distal and Lateral Subungual Onychomycosis

Interventions

Type	Name	Description
DRUG	Luliconazole Solution, 10%	Topical
DRUG	Vehicle Solution	Topical

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-06-01
• Completion: 2014-08-01
• First posted: 2011-09-12
• Last updated: 2015-11-30

Locations

28 sites across 1 country: United States