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NCT02824926

Non-inferiority Phase II Trial Comparing BL123 (Biolab Sanus Farmacêutica Ltda.) Versus Ketoconazole (Nizoral® Janssen-Cilag) in Patients With Tinea Pedis

Completed Phase 2 Last updated 3 July 2016
What this trial tests

Phase 2 trial testing Dapaconazole in Tinea Pedis in 60 participants. Completed in 1 January 2015.

Timeline
1 July 2014
Primary endpoint
1 December 2014
1 January 2015

Quick facts

Lead sponsorGilberto De Nucci
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment60
Start date1 July 2014
Primary completion1 December 2014
Estimated completion1 January 2015

Drugs / interventions tested

Conditions studied

Sponsor

Gilberto De Nucci

Who can join

Adults 18 to 60, any sex, with Tinea Pedis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Dapaconazole

Trials testing the same drug.

Other recruiting trials for Tinea Pedis

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02824926.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing