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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fungal Infections Tinea Pedis Tinea Cruris Tinea Corporis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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tonaftato

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

Group Type EXPERIMENTAL

Clotrimazole

Intervention Type DRUG

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

Interventions

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Clotrimazole

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No