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

April 11, 2012 updated by: Laboratório Teuto Brasileiro S/A

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"

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo
      • Santo André, São Paulo, Brazil
        • Faculdade de Medicina do ABC
        • Contact:
          • Dr. Carlos Machado
        • Contact:
          • Monice Karolis
        • Principal Investigator:
          • Dr. Carlos Machado
        • Principal Investigator:
          • Dra. Andréa Gerbase
        • Principal Investigator:
          • Dra. Denise Steiner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the efficacy and safety of the tolnaftate cream 10 mg / g.
Time Frame: 97 days
Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.
97 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratório Teuto Brasileiro S/A

Investigators

  • Study Director: Dagoberto Brandão, PHC - Pharma Consulting

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

April 14, 2010

First Submitted That Met QC Criteria

April 15, 2010

First Posted (Estimate)

April 16, 2010

Study Record Updates

Last Update Posted (Estimate)

April 12, 2012

Last Update Submitted That Met QC Criteria

April 11, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEU-TOL-03/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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