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

Phase 3

• Conditions: Fungal Infections; Tinea Pedis; Tinea Cruris; Tinea Corporis
• Interventions: Drug: Clotrimazole

• Registration Number: NCT01105013
• Lead Sponsor: Laboratório Teuto Brasileiro S/A

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.

Study Timeline

• Study First Submitted: 2010-04-14
• Study First Submitted QC: 2010-04-15
• Study First Posted: 2010-04-16
• Status Verified: 2012-04
• Study Start: 2012-04
• Last Update Submitted: 2012-04-11
• Last Update Posted: 2012-04-12
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tonaftato	Clotrimazole	Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.

Primary Outcome Measures

Name	Time	Method
Evaluate the efficacy and safety of the tolnaftate cream 10 mg / g.	97 days	Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.

Trial Locations

Locations (1)

Faculdade de Medicina do ABC; 🇧🇷 Santo André, São Paulo, Brazil