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Trial record 19 of 32 for:    Clotrimazole AND day

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

Tracking Information
First Submitted Date  ICMJE April 14, 2010
First Posted Date  ICMJE April 16, 2010
Last Update Posted Date April 12, 2012
Study Start Date  ICMJE April 2012
Estimated Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01105013 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections
Official Title  ICMJE 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"
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Fungal Infections
  • Tinea Pedis
  • Tinea Cruris
  • Tinea Corporis
Intervention  ICMJE Drug: Clotrimazole
Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 15, 2010)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2012
Estimated Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01105013
Other Study ID Numbers  ICMJE TEU-TOL-03/09
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laboratório Teuto Brasileiro S/A
Study Sponsor  ICMJE Laboratório Teuto Brasileiro S/A
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dagoberto Brandão PHC - Pharma Consulting
PRS Account Laboratório Teuto Brasileiro S/A
Verification Date April 2012

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