Study Clinical, Multicenter, Phase III, to Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections Like Tinea Foot, Tinea and Tinea Crural Body"

Laboratório Teuto Brasileiro S/A1 site in 1 country90 target enrollmentApril 2012

ConditionsFungal Infections Tinea Pedis Tinea Cruris Tinea Corporis

InterventionsClotrimazole

DrugsClotrimazole

Overview

Phase: Phase 3
Intervention: Clotrimazole
Conditions: Fungal Infections
Sponsor: Laboratório Teuto Brasileiro S/A
Enrollment: 90
Locations: 1
Primary Endpoint: Evaluate the efficacy and safety of the tolnaftate cream 10 mg / g.
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a study clinical, multicenter, Phase III trial, to evaluate the efficacy and safety of tolnaftate cream in the treatment of patients with fungal infections such as Tinea foot, Tinea and Tinea crural body.

Detailed Description

Study Clinical, multicenter, Phase III, to evaluate the efficacy and safety of 10mg/g tolnaftate cream in the treatment of patients with fungal infections such as Tinea foot, Tinea and Tinea crural body.

Registry

clinicaltrials.gov

Start Date

April 2012

End Date

July 2012

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Laboratório Teuto Brasileiro S/A

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients of both sexes, of any race, aged 12 years;
•Ability to understand and sign the IC (for patients older than age) in the case of minors monitoring and consent of a guardian;
•Clinical diagnosis of fungal infections for tinea pedis (ringworm of the feet) or tinea cruris (ringworm of the groin region), or tinea corporis (ringworm in other body areas);
•Direct mycological exam positive for fungi;

Exclusion Criteria

•Pregnant women or nursing mothers;
•Use of topical or oral antifungal;
•Use of steroids;
•Allergy or hypersensitivity to any component of product;
•Clinical cases of tinea infection by bacteria and / or eczema, tinea extensive and onychomycosis.