NCT03359070

Clinical Trial Comparing Dapaconazole Versus Miconazole in Patients With Tinea Cruris

Clinical Study of Non-inferiority (Phase 2), Comparing Dapaconazole (BL123 - Biolab Sanus Farmacêutica Ltda.) Versus Miconazole Nitrate (União Química) in Patients With a Single Lesion of Tinea Cruris.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Galeno Desenvolvimento de Pesquisas Clínicas · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This trial aims to evaluate the efficacy of dapaconazole tosylate 2% cream in the treatment of Tinea cruris compared to the active control miconazole nitrate 2% cream in patients with a single lesion.

Detailed description

This is a phase 2, non-inferiority, monocentric, double-blind, randomized (allocation of treatment), balanced, controlled (active comparator) trial, with two parallel groups. Randomization depended on inclusion/exclusion criteria, taking into account the confirmation of diagnosis by the direct mycological test and culture performed during the screening phase. Participants showed up to the clinic, for treatment, during 14 consecutive days, when one of the investigational products (according to the randomization) was applied by a blind member of the study staff. A non-blind member of the study staff weighed the corresponding investigational product and passed 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 was also performed after 7 and after 14 days of treatment. Safety analysis was 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 was based on the per protocol set. It was deemed as per protocol those participants who did not miss more than 20% of the applications and, also, no more than four consecutive application days.

Conditions

• Tinea Cruris

Interventions

Type	Name	Description
DRUG	Dapaconazole	Application of 1 gram on the lesion.
DRUG	Miconazole Nitrate	Application of 1 gram on the lesion.

Timeline

• Start date: 2014-01-29
• Primary completion: 2014-12-10
• Completion: 2015-05-06
• First posted: 2017-12-02
• Last updated: 2017-12-02

Locations

1 site across 1 country: Brazil