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

Primary Purpose

Fungal Infections, Tinea Pedis, Tinea Cruris

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Clotrimazole
Sponsored by
Laboratório Teuto Brasileiro S/A
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fungal Infections focused on measuring fungal infections, tinea, tonaftato

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Faculdade de Medicina do ABC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tonaftato

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 14, 2010
Last Updated
April 11, 2012
Sponsor
Laboratório Teuto Brasileiro S/A
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1. Study Identification

Unique Protocol Identification Number
NCT01105013
Brief Title
Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections
Acronym
Tonaftato
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 Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratório Teuto Brasileiro S/A

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fungal Infections, Tinea Pedis, Tinea Cruris, Tinea Corporis
Keywords
fungal infections, tinea, tonaftato

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tonaftato
Arm Type
Experimental
Arm Description
Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.
Intervention Type
Drug
Intervention Name(s)
Clotrimazole
Intervention Description
Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.
Primary Outcome Measure Information:
Title
Evaluate the efficacy and safety of the tolnaftate cream 10 mg / g.
Description
Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.
Time Frame
97 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Machado Filho, investigator
Phone
55 11 99018981
Email
dermatologia@fmabc.br
First Name & Middle Initial & Last Name or Official Title & Degree
Monice Karolis, coordinator
Phone
55 11 97963572
Email
monicekarolis@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dagoberto Brandão
Organizational Affiliation
PHC - Pharma Consulting
Official's Role
Study Director
Facility Information:
Facility Name
Faculdade de Medicina do ABC
City
Santo André
State/Province
São Paulo
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Carlos Machado
First Name & Middle Initial & Last Name & Degree
Monice Karolis
First Name & Middle Initial & Last Name & Degree
Dr. Carlos Machado
First Name & Middle Initial & Last Name & Degree
Dra. Andréa Gerbase
First Name & Middle Initial & Last Name & Degree
Dra. Denise Steiner

12. IPD Sharing Statement

Learn more about this trial

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

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