Tinea Pedis Clinical Trial
Official title:
Non-inferiority, Phase III Clinical Trial Comparing Dapaconazole Cream 2% (Biolab Sanus Farmacêutica Ltda.) Versus Ketoconazole Cream 2% (Nizoral® Janssen-Cilag) in Patients With Tinea Pedis
This is a non-inferiority, Phase III, open-label, randomized, parallel trial to evaluate the
new intervention Dapaconazole cream 2% versus Ketoconazole cream 2% in patients with Tinea
pedis. Sample size is 140 participants (70 per treatment group), male or female, aged
between 16 and 60 years-old.
Primary objective is to evaluate non-inferiority of Dapaconazole cream 2% compared to
Ketoconazole cream 2% in Tinea pedis treatment. Secondary objective is to evaluate safety
and tolerability of Dapaconazole cream 2% after multiple administrations.
Participants will receive either new intervention or active control during 14 consecutive
days, which will be followed by 2 follow-up visits.
Primary efficacy endpoint is clinical and mycological lesion cure, and secondary efficacy
endpoint is time (days) until clinical diagnosis of lesion cure. Additionally, safety will
be assessed by adverse events occurrence and laboratory exams evaluation.
n/a
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|---|---|---|---|
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