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

Topica Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Distal and Lateral Subungual Onychomycosis

Treatments: Drug: Luliconazole Solution, 10%; Drug: Vehicle Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01431820

TP-1009-S

Details and patient eligibility

About

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.

Enrollment: 334 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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334 participants in 4 patient groups, including a placebo group

Luliconazole Solution, 10% Regimen 1

Experimental group

Treatment:

Drug: Luliconazole Solution, 10%

Luliconazole Solution, 10% Regimen 2

Experimental group

Treatment:

Drug: Luliconazole Solution, 10%

Vehicle Solution Regimen 1

Placebo Comparator group

Treatment:

Drug: Vehicle Solution

Vehicle Solution Regimen 2

Placebo Comparator group

Treatment:

Drug: Vehicle Solution