Non-inferiority Trial of Dapaconazole Versus Ketoconazole

Summary

The main purpose of this study is to demonstrate that dapaconazole cream 2% (experimental drug) is non-inferior to ketoconazole cream 2% (Nizoral® - 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.

Timeline

Start

2017-11-01

Primary completion

2019-08-27

Completion

2019-11-12

Drugs

Indications