Tinea CrurisPhase 2NCT03359070
Clinical Trial Comparing Dapaconazole Versus Miconazole in Patients With Tinea Cruris
A Phase 2 study testing Dapaconazole and Miconazole Nitrate in people with Tinea Cruris, run by Galeno Desenvolvimento de Pesquisas Clínicas at 1 site in Brazil.
Trial summary
This trial aims to evaluate the efficacy of dapaconazole tosylate 2% cream in the treatment of Tinea cruris compared to the active control miconazole nitrate 2% cream in patients with a single lesion. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tinea Cruris
- What is being tested?
- Dapaconazole and Miconazole Nitrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Jan 2014to 6 May 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
- 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 of Tinea cruris, with an area not exceeding 8 cm², having, also, the diagnosis confirmed by direct mycological (KOH) test and fungus culture.
- No previous treatment with antimycotic medication 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
- Known hypersensitivity to miconazole or to chemically related compounds (azoles) or to the compounds of the investigational products.
- 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.
- 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.
- Pregnant or lactating women
- Participation in any clinical trial, or intake of any investigational product, within the last six months prior to the inclusion in the clinical trial.
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- History of drug addiction.
- Any prior treatment for the present lesion which, at investigator discretion, may interfere with the objectives of the clinical trial.
- Participants who has any condition that prevents him from participating in the study according to the investigator's judgment.
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: Clinical Study of Non-inferiority (Phase 2), Comparing Dapaconazole (BL123 - Biolab Sanus Farmacêutica Ltda.) Versus Miconazole Nitrate (União Química) in Patients With a Single Lesion of Tinea Cruris.
This trial aims to evaluate the efficacy of dapaconazole tosylate 2% cream in the treatment of Tinea cruris compared to the active control miconazole nitrate 2% cream in patients with a single lesion.
Read the detailed description
This is a phase 2, non-inferiority, monocentric, double-blind, randomized (allocation of treatment), balanced, controlled (active comparator) trial, with two parallel groups.
Randomization depended on inclusion/exclusion criteria, taking into account the confirmation of diagnosis by the direct mycological test and culture performed during the screening phase.
Participants showed up to the clinic, for treatment, during 14 consecutive days, when one of the investigational products (according to the randomization) was applied by a blind member of the study staff. A non-blind member of the study staff weighed the corresponding investigational product and passed 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 was also performed after 7 and after 14 days of treatment.
Safety analysis was 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 was based on the per protocol set. It was deemed as per protocol those participants who did not miss more than 20% of the applications and, also, no more than four consecutive application days.
- Conditions
- Tinea Cruris
- Being tested
- Dapaconazole, Miconazole Nitrate
- Keywords
- Tinea cruris, dapaconazole, topical antifungal, dermatophytoses
- Medical subject headings
- Tinea Cruris, Tinea
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 gram on the lesion.
Miconazole NitrateDrug
Also called Vodol
Application of 1 gram on the lesion.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - dapaconazole cream 2% | Experimental | Topical application of dapaconazole cream 2%, twice a day (7 to 8 a.m. and 6 to 7 p.m.) for 14 days. Receives: Drug: Dapaconazole |
| Group 2 - miconazole cream 2% | Active comparator | Topical application of miconazole cream 2%, twice a day (7 to 8 a.m. and 6 to 7 p.m.) for 14 days. Receives: Drug: Miconazole Nitrate |
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 and mycological cure, on the assessment performed after 14 days of treatment.
Clinical cure was considered when there was no more scaling of the lesions, total absence of erythema, itching and desquamation.
Mycological cure was defined as negative result for the direct mycological examination (potassium hydroxide [KOH] test) and a negative fungal culture.
Measured: 14 days of treatment
Secondary outcomes (2)
Number of days until clinical cure
Number of days elapsed between the day of start of treatment and the day when the clinical cure was diagnosed, according to the daily assessment, in each treatment group.
Measured: up to 14 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 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start29 Jan 2014
- Primary completion10 Dec 2014
- Study completion6 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea CrurisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galeno Desenvolvimento de Pesquisas Clínicas
- Sponsor type
- Other government
- Collaborators
- Biolab Sanus Farmaceutica
- Responsible party
- Principal investigator, Gilberto De Nucci, Galeno Desenvolvimento de Pesquisas Clínicas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359070
- Sponsor's protocol ID
- GDN 042/13
- Status last verified
- Nov 2017
- First submitted
- 27 Nov 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Non-inferiority (Phase 2), Comparing Dapaconazole (BL123 - Biolab Sanus Farmacêutica Ltda.) Versus Miconazole Nitrate (União Química) in Patients With a Single Lesion of Tinea Cruris.
- ClinicalTrials.gov ID
- NCT03359070
- Acronym / sponsor ID
- GDN 042/13
- Conditions
- Tinea Cruris
- Keywords
- Tinea cruris, dapaconazole, topical antifungal, dermatophytoses
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Galeno Desenvolvimento de Pesquisas ClínicasOther government
- Collaborators
- Biolab Sanus Farmaceutica
- Study start
- 29 Jan 2014 (actual)
- Primary completion
- 10 Dec 2014 (actual)
- Study completion
- 6 May 2015 (actual)
- First posted
- 2 Dec 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.
This trial aims to evaluate the efficacy of dapaconazole tosylate 2% cream in the treatment of Tinea cruris compared to the active control miconazole nitrate 2% cream in patients with a single lesion.
Detailed description
This is a phase 2, non-inferiority, monocentric, double-blind, randomized (allocation of treatment), balanced, controlled (active comparator) trial, with two parallel groups.
Randomization depended on inclusion/exclusion criteria, taking into account the confirmation of diagnosis by the direct mycological test and culture performed during the screening phase.
Participants showed up to the clinic, for treatment, during 14 consecutive days, when one of the investigational products (according to the randomization) was applied by a blind member of the study staff. A non-blind member of the study staff weighed the corresponding investigational product and passed 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 was also performed after 7 and after 14 days of treatment.
Safety analysis was 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 was based on the per protocol set. It was deemed as per protocol those participants who did 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%, twice a day (7 to 8 a.m. and 6 to 7 p.m.) for 14 days. |
| Group 2 - miconazole cream 2% | Active comparator | Drug: Miconazole NitrateTopical application of miconazole cream 2%, twice a day (7 to 8 a.m. and 6 to 7 p.m.) for 14 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 of Tinea cruris, with an area not exceeding 8 cm², having, also, the diagnosis confirmed by direct mycological (KOH) test and fungus culture.
- No previous treatment with antimycotic medication 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 (9 listed)
- Known hypersensitivity to miconazole or to chemically related compounds (azoles) or to the compounds of the investigational products.
- 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.
- 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.
- Pregnant or lactating women
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 gram on the lesion. | Drug | Group 1 - dapaconazole cream 2% |
| Miconazole NitrateAlso: VodolApplication of 1 gram on the lesion. | Drug | Group 2 - miconazole cream 2% |
Primary outcome
Proportion of participants with therapeutic cure.
Time frame: 14 days of treatment
Proportion of participants, in each treatment group, who achieved therapeutic cure, defined as both clinical and mycological cure, on the assessment performed after 14 days of treatment. Clinical cure was considered when there was no more scaling of the lesions, total absence of erythema, itching and desquamation. Mycological cure was defined as negative result for the direct mycological examination (potassium hydroxide [KOH] test) and a negative fungal culture.
2 secondary outcomes
Number of days until clinical cure
Time frame: up to 14 days
Number of adverse events per participant
Time frame: up to 30 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 2 Dec 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapaconazole and Miconazole Nitrate in people with Tinea Cruris, run by Galeno Desenvolvimento de Pesquisas Clínicas 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 9 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 2 Dec 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 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?
Proportion of participants with therapeutic cure. (time frame: 14 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 2 Dec 2017.