Back to resultsClinical Trial Comparing Dapaconazole Versus Miconazole in Patients With Tinea Cruris
Primary Purpose
Tinea Cruris
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Dapaconazole
Miconazole Nitrate
Sponsored by
About this trial
This is an interventional treatment trial for Tinea Cruris focused on measuring Tinea cruris, dapaconazole, topical antifungal, dermatophytoses
Eligibility Criteria
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.
Sites / Locations
- Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1 - dapaconazole cream 2%
Group 2 - miconazole cream 2%
Arm Description
Topical application of dapaconazole cream 2%, twice a day (7 to 8 a.m. and 6 to 7 p.m.) for 14 days.
Topical application of miconazole cream 2%, twice a day (7 to 8 a.m. and 6 to 7 p.m.) for 14 days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Number of adverse events per participant
Number of adverse events, in each treatment group, including clinically relevant alterations of vital signs and laboratory tests.
Full Information
NCT ID
NCT03359070
First Posted
November 27, 2017
Last Updated
November 27, 2017
Sponsor
Galeno Desenvolvimento de Pesquisas Clínicas
Collaborators
Biolab Sanus Farmaceutica
1. Study Identification
Unique Protocol Identification Number
NCT03359070
Brief Title
Clinical Trial Comparing Dapaconazole Versus Miconazole in Patients With Tinea Cruris
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 29, 2014 (Actual)
Primary Completion Date
December 10, 2014 (Actual)
Study Completion Date
May 6, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Galeno Desenvolvimento de Pesquisas Clínicas
Collaborators
Biolab Sanus Farmaceutica
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Cruris
Keywords
Tinea cruris, dapaconazole, topical antifungal, dermatophytoses
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 - dapaconazole cream 2%
Arm Type
Experimental
Arm Description
Topical application of dapaconazole cream 2%, twice a day (7 to 8 a.m. and 6 to 7 p.m.) for 14 days.
Arm Title
Group 2 - miconazole cream 2%
Arm Type
Active Comparator
Arm Description
Topical application of miconazole cream 2%, twice a day (7 to 8 a.m. and 6 to 7 p.m.) for 14 days.
Intervention Type
Drug
Intervention Name(s)
Dapaconazole
Other Intervention Name(s)
Zilt
Intervention Description
Application of 1 gram on the lesion.
Intervention Type
Drug
Intervention Name(s)
Miconazole Nitrate
Other Intervention Name(s)
Vodol
Intervention Description
Application of 1 gram on the lesion.
Primary Outcome Measure Information:
Title
Proportion of participants with therapeutic cure.
Description
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
Secondary Outcome Measure Information:
Title
Number of days until clinical cure
Description
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
Title
Number of adverse events per participant
Description
Number of adverse events, in each treatment group, including clinically relevant alterations of vital signs and laboratory tests.
Time Frame
up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME
City
Campinas
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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Clinical Trial Comparing Dapaconazole Versus Miconazole in Patients With Tinea Cruris
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