Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis
Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% 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.
Inclusion Criteria:

 -  Male or female study participants, aged between 16 and 60 years-old. Patients aged
 between 16 and 18 years-old will provide additional Assent Form before enrollment in
 the trial;

 -  Presence of a skin lesion characteristic of Tinea pedis, with diagnosis confirmed by
 direct mycological exam;

 -  Absence of previous antifungic treatment for the lesion under study;

 -  Absence of other significant diseases which, at the physician's discretion, could have
 an impact on subject's participation in the trial, according to protocol requirements,
 and study evaluations: medical history, blood pressure and heart rate measurements,
 physical examination and screening laboratory tests;

 -  Ability to understand the nature and objectives of the trial, including risks and
 adverse events; willingness to cooperate with the researcher and proceed according to
 all study requirements, which shall be confirmed by Informed Consent Form signature.

 Exclusion Criteria:

 -  Known hypersensitivity to ketoconazole or chemically related compounds; history of
 serious adverse reactions;

 -  Screening laboratory tests results showing clinically relevant deviations that, at the
 researcher discretion, prevent the subject to participate in the trial due to possible
 risks;

 -  Drugs addiction, including alcohol;

 -  Use of any previous treatment to the lesion under study that, according to principal
 investigator best judgement, might interfere in study objectives;

 -  Treatment, within 3 months before the trial, with any drugs known to have a
 well-established toxic potential to major organs;

 -  Participation in any other experimental research or administration of any experimental
 drug within 6 months before this trial;

 -  Pregnancy, labor or miscarriage with 12 weeks before study treatment;

 -  Any conditions, according to investigator's best judgement, that prevents the subject
 to participate in the trial.