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

This study is not yet open for participant recruitment.
Verified April 2012 by Laboratório Teuto Brasileiro S/A
Sponsor:
Information provided by (Responsible Party):
Laboratório Teuto Brasileiro S/A
ClinicalTrials.gov Identifier:
NCT01105013
First received: April 14, 2010
Last updated: April 11, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Fungal Infections
Tinea Pedis
Tinea Cruris
Tinea Corporis
 Drug: Clotrimazole
 Phase 3

Study Type: Interventional
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
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"

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Laboratório Teuto Brasileiro S/A:

Primary Outcome Measures:
  • Evaluate the efficacy and safety of the tolnaftate cream 10 mg / g. [ Time Frame: 97 days ] [ Designated as safety issue: Yes ]
    Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.


Estimated Enrollment: 90
Study Start Date: April 2012
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105013

Contacts
Contact: Carlos Machado Filho, investigator 55 11 99018981 dermatologia@fmabc.br
Contact: Monice Karolis, coordinator 55 11 97963572 monicekarolis@hotmail.com

Locations
Brazil
Faculdade de Medicina do ABC Not yet recruiting
Santo André, São Paulo, Brazil
Contact: Dr. Carlos Machado            
Contact: Monice Karolis            
Principal Investigator: Dr. Carlos Machado            
Principal Investigator: Dra. Andréa Gerbase            
Principal Investigator: Dra. Denise Steiner            
Sponsors and Collaborators
Laboratório Teuto Brasileiro S/A
Investigators
Study Director: Dagoberto Brandão PHC - Pharma Consulting
  More Information

No publications provided

Responsible Party: Laboratório Teuto Brasileiro S/A
ClinicalTrials.gov Identifier: NCT01105013     History of Changes
Other Study ID Numbers: TEU-TOL-03/09
Study First Received: April 14, 2010
Last Updated: April 11, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Laboratório Teuto Brasileiro S/A:
fungal infections
tinea
tonaftato

Additional relevant MeSH terms:
Mycoses
Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms
 Clotrimazole
Miconazole
Tolnaftate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents

ClinicalTrials.gov processed this record on May 16, 2013