Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections
Tonaftato
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"
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2012
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2010
CompletedFirst Posted
Study publicly available on registry
April 16, 2010
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedApril 12, 2012
April 1, 2012
3 months
April 14, 2010
April 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
97 days
Study Arms (1)
tonaftato
EXPERIMENTALApply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.
Interventions
Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dagoberto Brandão
PHC - Pharma Consulting
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2010
First Posted
April 16, 2010
Study Start
April 1, 2012
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
April 12, 2012
Record last verified: 2012-04