Onychomycosis
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of topical application of IDP-108 versus vehicle in treating patients with onychomycosis.
Interventions
DRUGIDP-108
Topical application once a day for 48 weeks
DRUGVehicle
Topical application once a day for 48 weeks
Sponsors
Dow Pharmaceutical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Clinically diagnosed onychomycosis of the target nail * Presence of mild to moderate onychomycosis, defined as 20 - 50% of the area of the target nail being clinically affected * Has a positive KOH examination from the target nail * Has a positive dermatophyte culture from the target nail
Exclusion criteria
* Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug * Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis * Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit * Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients who achieve clinical cure | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients who achieve clinical efficacy | 52 weeks |
| Percentage of patients who achieve mycologic cure | 52 weeks |
Countries
Canada, United States
Outcome results
None listed