Tinea Cruris Clinical Trial
Official title:
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.
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.
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.
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