Clinical Trial Comparing Dapaconazole Versus Miconazole in Patients With Tinea Cruris

• Status: Completed
• Trial end date: 2015-05-06
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galeno Desenvolvimento de Pesquisas Clínicas
• Collaborator: Biolab Sanus Farmaceutica
• Treatments: Clotrimazole; Miconazole

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.