Trials Sponsors Conditions Drugs Pricing

Conditions

Tinea Cruris

Keywords

Tinea crurisdapaconazoletopical antifungaldermatophytoses

Outcome Measures

Primary Outcomes (1)

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.
14 days of treatment

Secondary Outcomes (2)

Number of days until clinical cure
up to 14 days
Number of adverse events per participant
up to 30 days

Study Arms (2)

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.

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.

Drug: Miconazole Nitrate

Interventions

DapaconazoleDrug

Application of 1 gram on the lesion.

Also known as: Zilt

Group 1 - dapaconazole cream 2%

Miconazole NitrateDrug

Application of 1 gram on the lesion.

Also known as: Vodol

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

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.

Sponsors & Collaborators

Biolab Sanus Farmaceutica
Industrycollaborator
Galeno Desenvolvimento de Pesquisas Clínicas
Governmentlead

Study Sites (1)

Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME

Campinas, São Paulo, Brazil

MeSH Terms

Conditions

Tinea CrurisTinea

Interventions

1-(2-(2,4-dichlorophenyl)-2-(4-(trifluoromethyl)benzyloxy)ethyl)-1H-imidazoleMiconazole

Condition Hierarchy (Ancestors)

DermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousIntertrigoDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Enrollment

51 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER GOV
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Doctor

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 2, 2017

Study Start

January 29, 2014

Actual (reported)

Clinical Trial Comparing Dapaconazole Versus Miconazole in Patients With Tinea Cruris

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Group 1 - dapaconazole cream 2%

Group 2 - miconazole cream 2%

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Group 1 - dapaconazole cream 2%

Group 2 - miconazole cream 2%

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations