Tinea PedisPhase 3NCT03320486
Non-inferiority Trial of Dapaconazole Versus Ketoconazole
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
The main purpose of this study is to demonstrate that dapaconazole cream 2% (experimental drug) is non-inferior to ketoconazole cream 2% (Nizoral® - active comparator) for the treatment of dermatological lesions of Tinea pedis, when applied to the skin (topically) once daily during 28 days. Read more about this study
- Who is it for?
- Ages 18 to 65 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
- 360 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2017to 12 Nov 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged from 18 to 65 years old, male, or female with no childbearing potential or who are using an effective contraceptive method and who do not plan to become pregnant during the study period.
- Presence of dermatological lesion(s) of Tinea pedis, with a global clinical severity score ≥ 4, being a minimum score of 2 for itching or desquamation/maceration and a minimum score of 2 for erythema, having, also, the diagnosis confirmed by direct mycological (KOH) test.
- No previous treatment with antimycotic medication, in the last 2 months, for the current dermatologic lesion.
- No evidence of other significant diseases, that, at the investigator's discretion, may affect the participation in the clinical trial, in accordance with the protocol requirements.
- Ability to understand the nature and the objective of the clinical trial, including the risks and possible side effects; intention to cooperate with the investigator and act in accordance with the protocol requirements, as confirmed by the informed consent form signature.
Who cannot join
- Existing hepatic and/or renal diseases or other pathologic findings, which might interfere with the safety and tolerability of the active ingredients.
- Screening laboratory tests presenting deviations deemed as clinically significant, which, due to possible risks, prevents the participation in clinical trial.
- Known hypersensitivity to ketoconazole or to chemically related compounds (azoles) or to the compounds of the investigational products.
- Participants with severe or multiple drugs allergies, unless judged by the investigator as not clinically relevant to the participation in the clinical trial.
- Positive anti human immunodeficiency virus (anti-HIV) test, positive Hepatitis B Surface Antigen (HBs-Ag) test or positive anti hepatitis C virus (anti-HCV) test.
- Treatment, within 3 months prior to the start of the clinical trial treatment, with any drug known to have a well-established toxic potential to major organs.
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- Pregnant or lactating women
- Participation in any clinical trial, or intake of any investigational product, within the last twelve months prior to the inclusion in the clinical trial.
- Presence of onychomycosis.
- Presence of "Moccasin type" Tinea pedis.
- Presence of infected Tinea pedis, or any other infection or pathology that may confuse the treatment evaluation.
- History of drug addiction.
- Diseases that may alter the immune system and, consequently, the host's response to the fungal presence (immunosuppressed participants), as well as the use of systemic immunosuppressive drugs, chemotherapy or radiotherapy, during the 3 months prior to the start of treatment.
- Use of drugs that may interfere with the assessment of the results, as well as use of topical immunosuppressants, topical antibiotics or topical corticosteroids, within 2 months prior to the start of treatment.
- Use of antipruriginous drugs, including antihistaminics, within 72 hours prior to the start of treatment.
- History of alcohol dependence and/or regular intake of alcoholic food or beverages containing ≥ 20 g of pure ethanol per day.
- Any prior treatment for the present lesion which, at investigator discretion, may interfere with the objectives of the clinical trial.
- Participants who might be non-compliant to the study treatment and/or to the requirements and procedures of the protocol.
- Participants who are unable to understand written and verbal instructions, in particular those regarding the risks and inconveniences to which they will be exposed during the participation in the clinical trial.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME
Campinas, São Paulo
About this study
Official title: Phase 3, Multicenter, Double-blind, Randomized, Non-inferiority Clinical Trial of Dapaconazole Cream 2% (Biolab Sanus Farmacêutica Ltda.) Versus Ketoconazole Cream 2% (Nizoral®, Janssen-Cilag Farmacêutica Ltda.) in Patients With Tinea Pedis
The main purpose of this study is to demonstrate that dapaconazole cream 2% (experimental drug) is non-inferior to ketoconazole cream 2% (Nizoral® - active comparator) for the treatment of dermatological lesions of Tinea pedis, when applied to the skin (topically) once daily during 28 days. Additionally, the safety and tolerability aspects will be evaluated in a descriptive way, through the observation of the incidence of adverse events.
Read the detailed description
This is a non-inferiority, phase 3, multicenter, double-blind, randomized (allocation of treatment), balanced, controlled (active comparator) trial, with two parallel groups in a 1:1 proportion.
Randomization will depend on inclusion/exclusion criteria, taking into account the confirmation of diagnosis by the direct mycological test performed during the screening phase. However, cases whose diagnosis is not additionally confirmed by positive fungal culture (sampled during the screening phase) will be excluded from the efficacy analysis.
Participants will show up to the clinic, for treatment, during 42 consecutive days, when one of the investigational products (according to the randomization) will be applied by a blind member of the study staff. A non-blind member of the study staff will weigh the corresponding investigational product and pass on to the blind member only a spatula with the weighed product, in order to maintain the blinded aspect of the trial.
For exploratory purposes, clinical and mycological evaluations will also be performed after 7 and after 14 days of treatment.
Safety analysis will be performed considering all the randomized patients to which at least one dose of the investigational products has been applied, regardless of the result of the fungal culture.
Conclusion of non-inferiority will be based on the per protocol set. It will be deemed as per protocol those participants who do not miss more than 20% of the applications and, also, no more than four consecutive application days.
- Conditions
- Tinea Pedis
- Being tested
- Dapaconazole, Ketoconazole
- Keywords
- Mycoses, Dermatomycoses, Antifugal Agents, Dapaconazole
- Medical subject headings
- Tinea Pedis, Mycoses, Dermatomycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapaconazoleDrug
Also called Zilt
Application of 1 to 3 grams, depending on the lesion extension, per affected foot.
KetoconazoleDrug
Also called Nizoral®
Application of 1 to 3 grams, depending on the lesion extension, per affected foot.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - dapaconazole cream 2% | Experimental | Topical application of dapaconazole cream 2%, once daily, during 42 days. Receives: Drug: Dapaconazole |
| Group 2 - ketoconazole cream 2% | Active comparator | Topical application of ketoconazole cream 2%, once daily, during 42 days. Receives: Drug: Ketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with therapeutic cure
Proportion of participants, in each treatment group, who achieved therapeutic cure, defined as both clinical cure and mycological cure, on the assessment performed after 28 days of treatment.
Clinical cure is defined as a score ≤ 2 for the sum of scores attributed to each sign or symptom (erythema, maceration/peeling, fissuring/cracking, itching and burning) as evaluated by a four-point categorical scale (0=absent, 1=mild, 2=moderate, 3=severe).
Mycological cure is defined as negative result for the direct mycological examination (potassium hydroxide [KOH] test) and a negative fungal culture.
Measured: 28 days of treatment
Secondary outcomes (5)
Proportion of participants with therapeutic cure
Proportion of participants, in each treatment group, who achieved therapeutic cure, on the assessment performed after 42 days of treatment.
Measured: 42 days of treatment
Proportion of participants maintaining therapeutic cure
Proportion of participants, in each treatment group, maintaining the therapeutic cure in the evaluation performed approximately 14 days after the end of the 42 days treatment period.
Measured: 14 (±3) days after the end of treatment
Proportion of participants maintaining therapeutic cure
Proportion of participants, in each treatment group, maintaining the therapeutic cure in the evaluation performed approximately 28 days after the end of the 42 days treatment period.
Measured: 28 (±5) days after the end of treatment
Number of days until clinical cure
Number of days elapsed between the day of start of treatment and the day when the clinical cure is diagnosed, according to the daily assessment, in each treatment group.
Measured: up to 42 days
Number of adverse events per participant
Number of adverse events, in each treatment group, including clinically relevant alterations of vital signs and laboratory tests.
Measured: up to 80 (±5) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start1 Nov 2017
- Primary completion27 Aug 2019
- Study completion12 Nov 2019
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biolab Sanus Farmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilberto De Nucci, MD, Principal investigator, Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320486
- Sponsor's protocol ID
- GDN 018/16
- Status last verified
- Jul 2020
- First submitted
- 22 Oct 2017
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Multicenter, Double-blind, Randomized, Non-inferiority Clinical Trial of Dapaconazole Cream 2% (Biolab Sanus Farmacêutica Ltda.) Versus Ketoconazole Cream 2% (Nizoral®, Janssen-Cilag Farmacêutica Ltda.) in Patients With Tinea Pedis
- ClinicalTrials.gov ID
- NCT03320486
- Acronym / sponsor ID
- GDN 018/16
- Conditions
- Tinea Pedis
- Keywords
- Mycoses, Dermatomycoses, Antifugal Agents, Dapaconazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Biolab Sanus FarmaceuticaIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 27 Aug 2019 (actual)
- Study completion
- 12 Nov 2019 (actual)
- First posted
- 25 Oct 2017 (actual)
- 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.
The main purpose of this study is to demonstrate that dapaconazole cream 2% (experimental drug) is non-inferior to ketoconazole cream 2% (Nizoral® - active comparator) for the treatment of dermatological lesions of Tinea pedis, when applied to the skin (topically) once daily during 28 days. Additionally, the safety and tolerability aspects will be evaluated in a descriptive way, through the observation of the incidence of adverse events.
Detailed description
This is a non-inferiority, phase 3, multicenter, double-blind, randomized (allocation of treatment), balanced, controlled (active comparator) trial, with two parallel groups in a 1:1 proportion.
Randomization will depend on inclusion/exclusion criteria, taking into account the confirmation of diagnosis by the direct mycological test performed during the screening phase. However, cases whose diagnosis is not additionally confirmed by positive fungal culture (sampled during the screening phase) will be excluded from the efficacy analysis.
Participants will show up to the clinic, for treatment, during 42 consecutive days, when one of the investigational products (according to the randomization) will be applied by a blind member of the study staff. A non-blind member of the study staff will weigh the corresponding investigational product and pass on to the blind member only a spatula with the weighed product, in order to maintain the blinded aspect of the trial.
For exploratory purposes, clinical and mycological evaluations will also be performed after 7 and after 14 days of treatment.
Safety analysis will be performed considering all the randomized patients to which at least one dose of the investigational products has been applied, regardless of the result of the fungal culture.
Conclusion of non-inferiority will be based on the per protocol set. It will be deemed as per protocol those participants who do not miss more than 20% of the applications and, also, no more than four consecutive application days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - dapaconazole cream 2% | Experimental | Drug: DapaconazoleTopical application of dapaconazole cream 2%, once daily, during 42 days. |
| Group 2 - ketoconazole cream 2% | Active comparator | Drug: KetoconazoleTopical application of ketoconazole cream 2%, once daily, during 42 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants aged from 18 to 65 years old, male, or female with no childbearing potential or who are using an effective contraceptive method and who do not plan to become pregnant during the study period.
- Presence of dermatological lesion(s) of Tinea pedis, with a global clinical severity score ≥ 4, being a minimum score of 2 for itching or desquamation/maceration and a minimum score of 2 for erythema, having, also, the diagnosis confirmed by direct mycological (KOH) test.
- No previous treatment with antimycotic medication, in the last 2 months, for the current dermatologic lesion.
- No evidence of other significant diseases, that, at the investigator's discretion, may affect the participation in the clinical trial, in accordance with the protocol requirements.
- Ability to understand the nature and the objective of the clinical trial, including the risks and possible side effects; intention to cooperate with the investigator and act in accordance with the protocol requirements, as confirmed by the informed consent form signature.
Key exclusion criteria (19 listed)
- Existing hepatic and/or renal diseases or other pathologic findings, which might interfere with the safety and tolerability of the active ingredients.
- Screening laboratory tests presenting deviations deemed as clinically significant, which, due to possible risks, prevents the participation in clinical trial.
- Known hypersensitivity to ketoconazole or to chemically related compounds (azoles) or to the compounds of the investigational products.
- Participants with severe or multiple drugs allergies, unless judged by the investigator as not clinically relevant to the participation in the clinical trial.
- Positive anti human immunodeficiency virus (anti-HIV) test, positive Hepatitis B Surface Antigen (HBs-Ag) test or positive anti hepatitis C virus (anti-HCV) test.
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: ZiltApplication of 1 to 3 grams, depending on the lesion extension, per affected foot. | Drug | Group 1 - dapaconazole cream 2% |
| KetoconazoleAlso: Nizoral®Application of 1 to 3 grams, depending on the lesion extension, per affected foot. | Drug | Group 2 - ketoconazole cream 2% |
Primary outcome
Proportion of participants with therapeutic cure
Time frame: 28 days of treatment
Proportion of participants, in each treatment group, who achieved therapeutic cure, defined as both clinical cure and mycological cure, on the assessment performed after 28 days of treatment. Clinical cure is defined as a score ≤ 2 for the sum of scores attributed to each sign or symptom (erythema, maceration/peeling, fissuring/cracking, itching and burning) as evaluated by a four-point categorical scale (0=absent, 1=mild, 2=moderate, 3=severe). Mycological cure is defined as negative result for the direct mycological examination (potassium hydroxide [KOH] test) and a negative fungal culture.
5 secondary outcomes
Proportion of participants with therapeutic cure
Time frame: 42 days of treatment
Proportion of participants maintaining therapeutic cure
Time frame: 14 (±3) days after the end of treatment
Proportion of participants maintaining therapeutic cure
Time frame: 28 (±5) days after the end of treatment
Number of days until clinical cure
Time frame: up to 42 days
Number of adverse events per participant
Time frame: up to 80 (±5) 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 27 Jul 2020.
- Individual participant dataSharing planned: No
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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, MD principal investigator
Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME
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 19 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 27 Jul 2020. 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 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?
Proportion of participants with therapeutic cure (time frame: 28 days of treatment). 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 27 Jul 2020; AzTrials last refreshed its copy on 7 Nov 2026.