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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Tinea Pedis

Intervention / Treatment
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* Drug: Dapaconazole
* Drug: Ketoconazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dapaconazole<br>Dapaconazole 2% Cream Topical | Drug: Dapaconazole<br> <br> * Other names: BL123;|
| Active Comparator: Ketoconazole<br>Ketoconazole 2% Cream Topical | Drug: Ketoconazole<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure of the lesion | Assessment of presence or absence of the lesion by clinical examination | 14 days | 
| Mycological cure of the lesion | Laboratory test for presence or absence of Tinea pedis | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (days) until clinical diagnosis of lesion cure |  | 14 days |