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Non-inferiority Trial of Dapaconazole Versus Ketoconazole

NCT03320486 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2020-07-27

No results posted yet for this study

Summary

The main purpose of this study is to demonstrate that dapaconazole cream 2% (experimental drug) is non-inferior to ketoconazole cream 2% (Nizoral® - active comparator) for the treatment of dermatological lesions of Tinea pedis, when applied to the skin (topically) once daily during 28 days. Additionally, the safety and tolerability aspects will be evaluated in a descriptive way, through the observation of the incidence of adverse events.

Conditions

  • Tinea Pedis

Interventions

DRUG

Dapaconazole

Application of 1 to 3 grams, depending on the lesion extension, per affected foot.

DRUG

Ketoconazole

Application of 1 to 3 grams, depending on the lesion extension, per affected foot.

Sponsors & Collaborators

  • Biolab Sanus Farmaceutica

    lead INDUSTRY

Principal Investigators

  • Gilberto De Nucci, MD · Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2019-08-27
Completion
2019-11-12

Countries

  • Brazil

Study Locations

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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 NCT03320486 on ClinicalTrials.gov