Overview

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

Status:
Unknown status
Trial end date:
2012-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Laboratório Teuto Brasileiro S/A
Treatments:
Clotrimazole
Miconazole
Tolnaftate
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.