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

Sponsor

Laboratório Teuto Brasileiro S/A (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01105013

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

30.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fungal Infections Tinea Pedis Tinea Cruris Tinea Corporis	Drug: Clotrimazole	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Study Clinical, Multicenter, Phase III, to Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections Like Tinea Foot, Tinea and Tinea Crural Body"

Study Start Date :

Apr 1, 2012

Anticipated Primary Completion Date :

Jul 1, 2012

Anticipated Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tonaftato Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.	Drug: Clotrimazole Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.

Arm

Intervention/Treatment

Experimental: tonaftato

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

Drug: Clotrimazole

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts 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.