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

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ClinicalTrials.gov Identifier: NCT01105013
Recruitment Status : Unknown
Verified April 2012 by Laboratório Teuto Brasileiro S/A.
Recruitment status was:  Not yet recruiting
First Posted : April 16, 2010
Last Update Posted : April 12, 2012
Sponsor:
Information provided by (Responsible Party):
Laboratório Teuto Brasileiro S/A

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 Type : Interventional  (Clinical Trial)
Estimated 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 : April 2012
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Laboratório Teuto Brasileiro S/A
ClinicalTrials.gov Identifier: NCT01105013     History of Changes
Other Study ID Numbers: TEU-TOL-03/09
First Posted: April 16, 2010    Key Record Dates
Last Update Posted: April 12, 2012
Last Verified: April 2012

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Mycoses
Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms
Tolnaftate
Antifungal Agents
Anti-Infective Agents