Tinea PedisPhase 3NCT02606383
Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis
A Phase 3 study testing Dapaconazole and Ketoconazole in people with Tinea Pedis, run by Biolab Sanus Farmaceutica at 1 site in Brazil.
Trial summary
This is a non-inferiority, Phase III, open-label, randomized, parallel trial to evaluate the new intervention Dapaconazole cream 2% versus Ketoconazole cream 2% in patients with Tinea pedis. Sample size is 140 participants (70 per treatment group), male or female, aged between 16 and 60 years-old. Read more about this study
- Who is it for?
- Ages 16 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
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2016to Dec 2016
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female study participants, aged between 16 and 60 years-old. Patients aged between 16 and 18 years-old will provide additional Assent Form before enrollment in the trial;
- Presence of a skin lesion characteristic of Tinea pedis, with diagnosis confirmed by direct mycological exam;
- Absence of previous antifungic treatment for the lesion under study;
- Absence of other significant diseases which, at the 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 measurements, physical examination and screening laboratory tests;
- Ability to understand the nature and objectives of the trial, including 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;
- Screening laboratory tests results showing clinically relevant deviations that, at the researcher discretion, prevent the subject to participate in the trial due to possible risks;
- Drugs addiction, including alcohol;
- Use of any previous treatment to the lesion under study that, according to principal investigator best judgement, might interfere in study objectives;
- Treatment, within 3 months before the 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;
- Pregnancy, labor or miscarriage with 12 weeks before study treatment;
- Any conditions, according to investigator's best judgement, that prevents the subject to participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-inferiority, Phase III Clinical Trial Comparing Dapaconazole Cream 2% (Biolab Sanus Farmacêutica Ltda.) Versus Ketoconazole Cream 2% (Nizoral® Janssen-Cilag) in Patients With Tinea Pedis
This is a non-inferiority, Phase III, open-label, randomized, parallel trial to evaluate the new intervention Dapaconazole cream 2% versus Ketoconazole cream 2% in patients with Tinea pedis. Sample size is 140 participants (70 per treatment group), male or female, aged between 16 and 60 years-old.
Primary objective is to evaluate non-inferiority of Dapaconazole cream 2% compared to Ketoconazole cream 2% in Tinea pedis treatment. Secondary objective is to evaluate safety and tolerability of Dapaconazole cream 2% after multiple administrations.
Read more
Participants will receive either new intervention or active control during 14 consecutive days, which will be followed by 2 follow-up visits.
Primary efficacy endpoint is clinical and mycological lesion cure, and secondary efficacy endpoint is time (days) until clinical diagnosis of lesion cure. Additionally, safety will be assessed by adverse events occurrence and laboratory exams evaluation.
- 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
Also called BL123
KetoconazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Dapaconazole | Experimental | Dapaconazole 2% Cream Topical Receives: Drug: Dapaconazole |
| Ketoconazole | Active comparator | Ketoconazole 2% Cream 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
Assessment of presence or absence of the lesion by clinical examination
Measured: 14 days
Mycological cure of the lesion
Laboratory test for presence or absence of Tinea pedis
Measured: 14 days
Secondary outcomes (1)
Time (days) until clinical diagnosis of lesion cure
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 posted17 Nov 2015 (estimated)
- Study startJun 2016
- Primary completionDec 2016 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biolab Sanus Farmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilberto De Nucci, PhD, Principal investigator, Galeno Desenvolvimento de Pesquisas Ltda.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606383
- Sponsor's protocol ID
- GDN 007/15
- Status last verified
- Jan 2017
- First submitted
- 12 Nov 2015
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority, Phase III Clinical Trial Comparing Dapaconazole Cream 2% (Biolab Sanus Farmacêutica Ltda.) Versus Ketoconazole Cream 2% (Nizoral® Janssen-Cilag) in Patients With Tinea Pedis
- ClinicalTrials.gov ID
- NCT02606383
- Acronym / sponsor ID
- GDN 007/15
- Conditions
- Tinea Pedis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Biolab Sanus FarmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Dec 2016 (estimated)
- First posted
- 17 Nov 2015 (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 III, open-label, randomized, parallel trial to evaluate the new intervention Dapaconazole cream 2% versus Ketoconazole cream 2% in patients with Tinea pedis. Sample size is 140 participants (70 per treatment group), male or female, aged between 16 and 60 years-old.
Primary objective is to evaluate non-inferiority of Dapaconazole cream 2% compared to Ketoconazole cream 2% in Tinea pedis treatment. Secondary objective is to evaluate safety and tolerability of Dapaconazole cream 2% after multiple administrations.
Participants will receive either new intervention or active control during 14 consecutive days, which will be followed by 2 follow-up visits.
Primary efficacy endpoint is clinical and mycological lesion cure, and secondary efficacy endpoint is time (days) until clinical diagnosis of lesion cure. Additionally, safety will be assessed by adverse events occurrence and laboratory exams evaluation.
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: DapaconazoleDapaconazole 2% Cream Topical |
| Ketoconazole | Active comparator | Drug: KetoconazoleKetoconazole 2% Cream Topical |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male or female study participants, aged between 16 and 60 years-old. Patients aged between 16 and 18 years-old will provide additional Assent Form before enrollment in the trial;
- Presence of a skin lesion characteristic of Tinea pedis, with diagnosis confirmed by direct mycological exam;
- Absence of previous antifungic treatment for the lesion under study;
- Absence of other significant diseases which, at the 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 measurements, physical examination and screening laboratory tests;
- Ability to understand the nature and objectives of the trial, including 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 (8 listed)
- Known hypersensitivity to ketoconazole or chemically related compounds; history of serious adverse reactions;
- Screening laboratory tests results showing clinically relevant deviations that, at the researcher discretion, prevent the subject to participate in the trial due to possible risks;
- Drugs addiction, including alcohol;
- Use of any previous treatment to the lesion under study that, according to principal investigator best judgement, might interfere in study objectives;
- Treatment, within 3 months before the trial, with any drugs known to have a well-established toxic potential to major organs;
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 |
|---|---|---|
| DapaconazoleAlso: BL123 | Drug | Dapaconazole |
| Ketoconazole | Drug | Ketoconazole |
Primary outcome
Clinical cure of the lesion
Time frame: 14 days
Assessment of presence or absence of the lesion by clinical examination
Mycological cure of the lesion
Time frame: 14 days
Laboratory test for presence or absence of Tinea pedis
1 secondary outcome
Time (days) until clinical diagnosis of lesion cure
Time frame: 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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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.
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 Dapaconazole and Ketoconazole in people with Tinea Pedis, run by Biolab Sanus Farmaceutica 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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 1 Feb 2017. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 (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 1 Feb 2017.