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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):

April 14, 2010
April 16, 2010
April 12, 2012
April 2012
July 2012   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01105013 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections
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 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.
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Fungal Infections
  • Tinea Pedis
  • Tinea Cruris
  • Tinea Corporis
Drug: Clotrimazole
Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.
Experimental: tonaftato
Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.
Intervention: Drug: Clotrimazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
90
July 2012
July 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01105013
TEU-TOL-03/09
Yes
Not Provided
Not Provided
Laboratório Teuto Brasileiro S/A
Laboratório Teuto Brasileiro S/A
Not Provided
Study Director: Dagoberto Brandão PHC - Pharma Consulting
Laboratório Teuto Brasileiro S/A
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP