This trial is active, not recruiting.

Condition distal and lateral subungual onychomycosis
Treatments luliconazole solution, 10%, vehicle solution
Phase phase 2/phase 3
Sponsor Topica Pharmaceuticals
Start date May 2012
End date July 2014
Trial size 300 participants
Trial identifier NCT01431820, NCT01428856, TP-1009-S


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
luliconazole solution, 10%
luliconazole solution, 10%
(Placebo Comparator)
vehicle solution
(Placebo Comparator)
vehicle solution

Primary Outcomes

The proportion of subjects who achieve complete cure of the target great toenail
time frame: Week 52

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Topica Pharmaceuticals.