Clinical Trial Comparing Dapaconazole Versus Miconazole in Patients With Tinea Cruris
Clinical Trial Comparing Dapaconazole Versus Miconazole in Patients With 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.
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.
Inclusion Criteria:

 -  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.

 Exclusion Criteria:

 -  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.

 -  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.