Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections

Last updated: April 11, 2012
Sponsor: Laboratório Teuto Brasileiro S/A
Overall Status: Trial Status Unknown

Phase

3

Condition

Yeast Infections

Fungal Infections

Athlete's Foot (Tinea Pedis)

Treatment

N/A

Clinical Study ID

NCT01105013
TEU-TOL-03/09
  • Ages > 12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 ofminors monitoring and consent of a guardian;

  • Clinical diagnosis of fungal infections for tinea pedis (ringworm of the feet) ortinea cruris (ringworm of the groin region), or tinea corporis (ringworm in other bodyareas);

  • Direct mycological exam positive for fungi;

Exclusion

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 andonychomycosis.

Study Design

Total Participants: 90
Study Start date:
April 01, 2012
Estimated Completion Date:
July 31, 2012

Study 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.

Connect with a study center

  • Faculdade de Medicina do ABC

    Santo André, São Paulo
    Brazil

    Site Not Available

  • Faculdade de Medicina do ABC

    Santo André, São Paulo
    Brazil

    Site Not Available

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