NCT03320486

Non-inferiority Trial of Dapaconazole Versus Ketoconazole

Phase 3, Multicenter, Double-blind, Randomized, Non-inferiority Clinical Trial of Dapaconazole Cream 2% (Biolab Sanus Farmacêutica Ltda.) Versus Ketoconazole Cream 2% (Nizoral®, Janssen-Cilag Farmacêutica Ltda.) in Patients With Tinea Pedis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Biolab Sanus Farmaceutica · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a non-inferiority, phase 3, multicenter, double-blind, randomized (allocation of treatment), balanced, controlled (active comparator) trial, with two parallel groups in a 1:1 proportion. Randomization will depend on inclusion/exclusion criteria, taking into account the confirmation of diagnosis by the direct mycological test performed during the screening phase. However, cases whose diagnosis is not additionally confirmed by positive fungal culture (sampled during the screening phase) will be excluded from the efficacy analysis. Participants will show up to the clinic, for treatment, during 42 consecutive days, when one of the investigational products (according to the randomization) will be applied by a blind member of the study staff. A non-blind member of the study staff will weigh the corresponding investigational product and pass on to the blind member only a spatula with the weighed product, in order to maintain the blinded aspect of the trial. For exploratory purposes, clinical and mycological evaluations will also be performed after 7 and after 14 days of treatment. Safety analysis will be performed considering all the randomized patients to which at least one dose of the investigational products has been applied, regardless of the result of the fungal culture. Conclusion of non-inferiority will be based on the per protocol set. It will be deemed as per protocol those participants who do not miss more than 20% of the applications and, also, no more than four consecutive application days.

Conditions

• Tinea Pedis

Interventions

Type	Name	Description
DRUG	Dapaconazole	Application of 1 to 3 grams, depending on the lesion extension, per affected foot.
DRUG	Ketoconazole	Application of 1 to 3 grams, depending on the lesion extension, per affected foot.

Timeline

• Start date: 2017-11-01
• Primary completion: 2019-08-27
• Completion: 2019-11-12
• First posted: 2017-10-25
• Last updated: 2020-07-27

Locations

1 site across 1 country: Brazil