Clinical Trial Comparing BL123 Versus Ketoconazole in Patients With Tinea Pedis

Study Overview
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Brief Summary
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This is a non-inferiority, Phase II, open-label, randomized, parallel trial to evaluate efficacy and safety of the new intervention (Dapaconazole cream 2%) versus the active control (Ketoconazole cream 2%) in patients with Tinea Pedis. Study schedule comprises enrollment, treatment and follow-up visits. Treatment period is 14 days.

Detailed Description
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The study sample consists of male and female subjects aged between 18 and 60 years-old, either with single or multiple Tinea Pedis lesion(s). Sixty (60) patients will be enrolled, but each foot with lesion(s) will be considered as one (1) sample. Therefore, if a patient has bilateral lesions, one foot will be allocated to investigational product (Dapaconazole) and the other foot will be allocated to active control (Ketoconazole). Randomization will determine which foot (right or left) will be treated with Dapaconazole or Ketoconazole.

Official Title
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Non-inferiority Phase II Trial Comparing BL123 (Biolab Sanus Farmacêutica Ltda.) Versus Ketoconazole (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 subjects, aged between 18 and 60 years-old; Presence of skin lesion(s) characteristic of Tinea Pedis, with diagnosis confirmed by direct mycological exam; Absence of previous antifungic treatment for the current lesion(s) under study; Absence of other significant diseases which, at 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, physical examination and screening laboratory tests; Ability to understand the nature and objectives of the trial, including its 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; Current evidence of clinically significant diseases which, at physician's discretion, prevent subject's participation in the trial and/or expose the subject to risks other than what is normally expected; Use of medications that, at principal investigator's discretion, might expose the subject to risks other than what is normally expected; Screening laboratory tests results showing clinically relevant deviations that, due to potential risks, prevent participation in the trial, at the researcher's discretion; Drugs addiction, including alcohol; Use of any previous treatment to the lesion(s) under study that, according to principal investigator's discretion, might interfere with the study objectives; Treatment, within 3 months before this 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; Positive pregnancy test, labor or miscarriage within 12 weeks before study treatment; Any conditions, according to investigator's discretion, that prevent subjects to participate in the trial.

Ages Eligible for Study
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Minimum Age: 18 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>(cream; 2%; topical) | Drug: Dapaconazole<br> <br> |
| Active Comparator: Ketoconazole<br>(cream; 2%; 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(s) | Assessment of presence or absence of lesion(s) by clinical examination | 14 days | 
| Mycological cure of the lesion(s) | Laboratory test for presence or absence of Tinea Pedis | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (days) to clinical diagnosis of lesion(s) cure |  | 14 days | 
| Time (days) to absence of itching at lesion(s) site |  | 14 days |