Clinical Trial Comparing BL123 Versus Ketoconazole in Patients With Tinea Pedis

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilberto De Nucci
• Collaborator: Biolab Sanus Farmaceutica
• Treatments: Ketoconazole

Criteria

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.