Tinea PedisPhase 2NCT02824926
Clinical Trial Comparing BL123 Versus Ketoconazole in Patients With Tinea Pedis
A Phase 2 study testing Dapaconazole and Ketoconazole in people with Tinea Pedis, run by Gilberto De Nucci.
Trial summary
This is a non-inferiority, Phase II, open-label, randomized, parallel trial to evaluate efficacy and safety of the new intervention (Dapaconazole cream 2%) versus the active control (Ketoconazole cream 2%) in patients with Tinea Pedis. Study schedule comprises enrollment, treatment and follow-up visits. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- Dapaconazole and Ketoconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jan 2015
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects, aged between 18 and 60 years-old;
- Presence of skin lesion(s) characteristic of Tinea Pedis, with diagnosis confirmed by direct mycological exam;
- Absence of previous antifungic treatment for the current lesion(s) under study;
- Absence of other significant diseases which, at physician's discretion, could have an impact on subject's participation in the trial, according to protocol requirements and study evaluations: medical history, blood pressure and heart rate, physical examination and screening laboratory tests;
- Ability to understand the nature and objectives of the trial, including its risks and adverse events; willingness to cooperate with the researcher and proceed according to all study requirements, which shall be confirmed by Informed Consent Form signature.
Who cannot join
- Known hypersensitivity to ketoconazole or chemically related compounds; history of serious adverse reactions;
- Current evidence of clinically significant diseases which, at physician's discretion, prevent subject's participation in the trial and/or expose the subject to risks other than what is normally expected;
- Use of medications that, at principal investigator's discretion, might expose the subject to risks other than what is normally expected;
- Screening laboratory tests results showing clinically relevant deviations that, due to potential risks, prevent participation in the trial, at the researcher's discretion;
- Drugs addiction, including alcohol;
- Use of any previous treatment to the lesion(s) under study that, according to principal investigator's discretion, might interfere with the study objectives;
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- Treatment, within 3 months before this trial, with any drugs known to have a well-established toxic potential to major organs;
- Participation in any other experimental research or administration of any experimental drug within 6 months before this trial;
- Positive pregnancy test, labor or miscarriage within 12 weeks before study treatment;
- Any conditions, according to investigator's discretion, that prevent subjects to participate in the trial.
About this study
Official title: Non-inferiority Phase II Trial Comparing BL123 (Biolab Sanus Farmacêutica Ltda.) Versus Ketoconazole (Nizoral® Janssen-Cilag) in Patients With Tinea Pedis
This is a non-inferiority, Phase II, open-label, randomized, parallel trial to evaluate efficacy and safety of the new intervention (Dapaconazole cream 2%) versus the active control (Ketoconazole cream 2%) in patients with Tinea Pedis. Study schedule comprises enrollment, treatment and follow-up visits. Treatment period is 14 days.
Read the detailed description
The study sample consists of male and female subjects aged between 18 and 60 years-old, either with single or multiple Tinea Pedis lesion(s). Sixty (60) patients will be enrolled, but each foot with lesion(s) will be considered as one (1) sample. Therefore, if a patient has bilateral lesions, one foot will be allocated to investigational product (Dapaconazole) and the other foot will be allocated to active control (Ketoconazole). Randomization will determine which foot (right or left) will be treated with Dapaconazole or Ketoconazole.
- Conditions
- Tinea Pedis
- Being tested
- Dapaconazole, Ketoconazole
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapaconazoleDrug
KetoconazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Dapaconazole | Experimental | (cream; 2%; topical) Receives: Drug: Dapaconazole |
| Ketoconazole | Active comparator | (cream; 2%; topical) Receives: Drug: Ketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure of the lesion(s)
Assessment of presence or absence of lesion(s) by clinical examination
Measured: 14 days
Mycological cure of the lesion(s)
Laboratory test for presence or absence of Tinea Pedis
Measured: 14 days
Secondary outcomes (2)
Time (days) to clinical diagnosis of lesion(s) cure
Measured: 14 days
Time (days) to absence of itching at lesion(s) site
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea PedisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilberto De Nucci
- Sponsor type
- Other government
- Collaborators
- Biolab Sanus Farmaceutica
- Responsible party
- Sponsor-investigator, Gilberto De Nucci, Galeno Desenvolvimento de Pesquisas Clínicas
- Investigators
- Gilberto De Nucci, PhD, Principal investigator, Galeno Desenvolvimento de Pesquisas Ltda.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824926
- Sponsor's protocol ID
- GDN 083/13
- Status last verified
- Jul 2016
- First submitted
- 30 Jun 2016
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: No IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Phase II Trial Comparing BL123 (Biolab Sanus Farmacêutica Ltda.) Versus Ketoconazole (Nizoral® Janssen-Cilag) in Patients With Tinea Pedis
- ClinicalTrials.gov ID
- NCT02824926
- Acronym / sponsor ID
- GDN 083/13
- Conditions
- Tinea Pedis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gilberto De NucciOther government
- Collaborators
- Biolab Sanus Farmaceutica
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 7 Jul 2016 (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 non-inferiority, Phase II, open-label, randomized, parallel trial to evaluate efficacy and safety of the new intervention (Dapaconazole cream 2%) versus the active control (Ketoconazole cream 2%) in patients with Tinea Pedis. Study schedule comprises enrollment, treatment and follow-up visits. Treatment period is 14 days.
Detailed description
The study sample consists of male and female subjects aged between 18 and 60 years-old, either with single or multiple Tinea Pedis lesion(s). Sixty (60) patients will be enrolled, but each foot with lesion(s) will be considered as one (1) sample. Therefore, if a patient has bilateral lesions, one foot will be allocated to investigational product (Dapaconazole) and the other foot will be allocated to active control (Ketoconazole). Randomization will determine which foot (right or left) will be treated with Dapaconazole or Ketoconazole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapaconazole | Experimental | Drug: Dapaconazole(cream; 2%; topical) |
| Ketoconazole | Active comparator | Drug: Ketoconazole(cream; 2%; topical) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female subjects, aged between 18 and 60 years-old;
- Presence of skin lesion(s) characteristic of Tinea Pedis, with diagnosis confirmed by direct mycological exam;
- Absence of previous antifungic treatment for the current lesion(s) under study;
- Absence of other significant diseases which, at physician's discretion, could have an impact on subject's participation in the trial, according to protocol requirements and study evaluations: medical history, blood pressure and heart rate, physical examination and screening laboratory tests;
- Ability to understand the nature and objectives of the trial, including its risks and adverse events; willingness to cooperate with the researcher and proceed according to all study requirements, which shall be confirmed by Informed Consent Form signature.
Key exclusion criteria (10 listed)
- Known hypersensitivity to ketoconazole or chemically related compounds; history of serious adverse reactions;
- Current evidence of clinically significant diseases which, at physician's discretion, prevent subject's participation in the trial and/or expose the subject to risks other than what is normally expected;
- Use of medications that, at principal investigator's discretion, might expose the subject to risks other than what is normally expected;
- Screening laboratory tests results showing clinically relevant deviations that, due to potential risks, prevent participation in the trial, at the researcher's discretion;
- Drugs addiction, including alcohol;
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 |
|---|---|---|
| Dapaconazole | Drug | Dapaconazole |
| Ketoconazole | Drug | Ketoconazole |
Primary outcome
Clinical cure of the lesion(s)
Time frame: 14 days
Assessment of presence or absence of lesion(s) by clinical examination
Mycological cure of the lesion(s)
Time frame: 14 days
Laboratory test for presence or absence of Tinea Pedis
2 secondary outcomes
Time (days) to clinical diagnosis of lesion(s) cure
Time frame: 14 days
Time (days) to absence of itching at lesion(s) site
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Individual participant dataSharing planned: Yes. No IPD available.
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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.
Gilberto De Nucci, PhD principal investigator
Galeno Desenvolvimento de Pesquisas Ltda.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapaconazole and Ketoconazole in people with Tinea Pedis, run by Gilberto De Nucci.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure of the lesion(s) (time frame: 14 days). The study lists 2 primary outcomes in all. 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 7 Jul 2016.