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Clinical Trial Comparing BL123 Versus Ketoconazole in Patients With Tinea Pedis

NCT02824926 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-07-07

No results posted yet for this study

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.

Conditions

  • Tinea Pedis

Interventions

DRUG

Dapaconazole

DRUG

Ketoconazole

Sponsors & Collaborators

  • Gilberto De Nucci

    lead OTHER_GOV

  • Biolab Sanus Farmaceutica

    collaborator INDUSTRY

Principal Investigators

  • Gilberto De Nucci, PhD · Galeno Desenvolvimento de Pesquisas Ltda.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2014-12-31
Completion
2015-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02824926 on ClinicalTrials.gov