Overview

Non-inferiority Trial of Dapaconazole Versus Ketoconazole

Status:
Completed
Trial end date:
2019-11-12
Target enrollment:
Participant gender:
Summary
The main purpose of this study is to demonstrate that dapaconazole cream 2% (experimental drug) is non-inferior to ketoconazole cream 2% (NizoralĀ® - active comparator) for the treatment of dermatological lesions of Tinea pedis, when applied to the skin (topically) once daily during 28 days. Additionally, the safety and tolerability aspects will be evaluated in a descriptive way, through the observation of the incidence of adverse events.
Phase:
Phase 3
Details
Lead Sponsor:
Biolab Sanus Farmaceutica
Treatments:
Ketoconazole