Distal and Lateral Subungual Onychomycosis
Conditions
Keywords
Onychomycosis, Toenail Fungus, luliconazole, Antifungal, Topical
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.
Interventions
Topical
DRUGVehicle Solution
Topical
Sponsors
Topica Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who achieve complete cure of the target great toenail | Week 52 |
Countries
United States
Outcome results
None listed