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

Laboratório Teuto Brasileiro

Status and phase

Unknown

Phase 3

Conditions

Tinea Pedis

Fungal Infections

Tinea Cruris

Tinea Corporis

Treatments

Drug: Clotrimazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT01105013

TEU-TOL-03/09

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.