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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Clínica Gobbato de Dermatologia
Rio Claro, São Paulo, Brazil
Clinical cure of the lesion
Assessment of presence or absence of the lesion by clinical examination
Time frame: 14 days
Mycological cure of the lesion
Laboratory test for presence or absence of Tinea pedis
Time frame: 14 days
Time (days) until clinical diagnosis of lesion cure
Time frame: 14 days
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