Fungal InfectionsPhase 3TonaftatoNCT01105013
Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections
A Phase 3 study testing Clotrimazole in people with Fungal Infections and Tinea Pedis, run by Laboratório Teuto Brasileiro S/A at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Fungal Infections, Tinea Pedis, Tinea Cruris
- What is being tested?
- Clotrimazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2012to Jul 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Medicina do ABC
Santo André, São Paulo
Dr. Carlos Machado
Monice Karolis
About this study
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"
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.
Read the 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.
- Conditions
- Fungal Infections, Tinea Pedis, Tinea Cruris, Tinea Corporis
- Being tested
- Clotrimazole
- Keywords
- fungal infections, tinea, tonaftato
- Medical subject headings
- Mycoses, Tinea Pedis, Tinea Cruris, Tinea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClotrimazoleDrug
Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.
| Study group | Role | What they receive |
|---|---|---|
| tonaftato | Experimental | Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days. Receives: Drug: Clotrimazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 97 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startApr 2012
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratório Teuto Brasileiro S/A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dagoberto Brandão, Study director, PHC - Pharma Consulting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105013
- Sponsor's protocol ID
- TEU-TOL-03/09
- Acronym
- Tonaftato
- Status last verified
- Apr 2012
- First submitted
- 14 Apr 2010
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT01105013
- Acronym / sponsor ID
- Tonaftato / TEU-TOL-03/09
- Conditions
- Fungal Infections, Tinea Pedis, Tinea Cruris, Tinea Corporis
- Keywords
- fungal infections, tinea, tonaftato
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Laboratório Teuto Brasileiro S/AIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 16 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tonaftato | Experimental | Drug: ClotrimazoleApply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClotrimazoleApply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days. | Drug | tonaftato |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dagoberto Brandão study director
PHC - Pharma Consulting
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clotrimazole in people with Fungal Infections and Tinea Pedis, run by Laboratório Teuto Brasileiro S/A at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Machado Filho, investigator (55 11 99018981, dermatologia@fmabc.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy and safety of the tolnaftate cream 10 mg / g. (time frame: 97 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2012.