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

Information source: Laboratório Teuto Brasileiro S/A
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fungal Infections; Tinea Pedis; Tinea Cruris; Tinea Corporis

Intervention: Clotrimazole (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Laboratório Teuto Brasileiro S/A

Official(s) and/or principal investigator(s):
Dagoberto Brandão, Study Director, Affiliation: PHC - Pharma Consulting

Overall contact:
Carlos Machado Filho, investigator, Phone: 55 11 99018981, Email: dermatologia@fmabc.br

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.

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Evaluate the efficacy and safety of the tolnaftate cream 10 mg / g.

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.

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Carlos Machado Filho, investigator, Phone: 55 11 99018981, Email: dermatologia@fmabc.br

Faculdade de Medicina do ABC, Santo André, São Paulo, Brazil; Not yet recruiting
Dr. Carlos Machado
Monice Karolis
Dr. Carlos Machado, Principal Investigator
Dra. Andréa Gerbase, Principal Investigator
Dra. Denise Steiner, Principal Investigator
Additional Information

Starting date: April 2012
Last updated: April 11, 2012

Page last updated: August 23, 2015

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