A Phase 2 interventional study of Dapaconazole and Miconazole Nitrate in Tinea Cruris, sponsored by Galeno Desenvolvimento de Pesquisas Clínicas. Completed at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-12-02.
Sponsored by Galeno Desenvolvimento de Pesquisas Clínicas · Phase 2, Interventional, and Treatment
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.
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.
39 studies on the registry are indexed under Tinea; 8 are open to participants now.
This study's enrollment of 51 is below the median of 64 across 33 interventional studies indexed under Tinea.
Browse Tinea studies →Galeno Desenvolvimento de Pesquisas Clínicas is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Topical application of dapaconazole cream 2%, twice a day (7 to 8 a.m. and 6 to 7 p.m.) for 14 days.
Drug: Dapaconazole
Topical application of miconazole cream 2%, twice a day (7 to 8 a.m. and 6 to 7 p.m.) for 14 days.
Drug: Miconazole Nitrate
Application of 1 gram on the lesion.
Also known as: Zilt
Application of 1 gram on the lesion.
Also known as: Vodol
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.
Time frame: 14 days 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 was diagnosed, according to the daily assessment, in each treatment group.
Time frame: 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.
Time frame: up to 30 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dapaconazole
Galeno Desenvolvimento de Pesquisas Clínicas