Clinical Trial Comparing Dapaconazole Versus Miconazole in Patients With Tinea Cruris

NCT03359070 | Completed Phase 2 DMC

• 1 other identifier: GDN 042/13
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinea Cruris

Keywords

Tinea cruris; dapaconazole; topical antifungal; dermatophytoses

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

Dapaconazole DRUG

Application of 1 gram on the lesion.

Also known as: Zilt

Group 1 - dapaconazole cream 2%

Miconazole Nitrate DRUG

Application of 1 gram on the lesion.

Also known as: Vodol

Group 2 - miconazole cream 2%

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Galeno Desenvolvimento de Pesquisas Clínicas: lead
• Biolab Sanus Farmaceutica: collaborator

Study Sites (1)

Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME

Campinas, São Paulo, Brazil

Location

MeSH Terms

Conditions

Tinea Cruris; Tinea

Interventions

1-(2-(2,4-dichlorophenyl)-2-(4-(trifluoromethyl)benzyloxy)ethyl)-1H-imidazole; Miconazole

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Intertrigo; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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
• Primary Completion: December 10, 2014
• Study Completion: May 6, 2015
• Last Updated: December 2, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)