Clinical Trial Comparing Dapaconazole Versus Miconazole in Patients With Tinea Cruris

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.

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.

Study Overview

• Status: Completed
• Conditions: Tinea Cruris
• Intervention / Treatment: Drug: Dapaconazole; Drug: Miconazole Nitrate

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Campinas, SP, Brazil
      • Galeno Desenvolvimento de Pesquisas Clinicas Ltda. - ME

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1 - dapaconazole cream 2%; 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; Application of 1 gram on the lesion.; Other Names: Zilt
ACTIVE_COMPARATOR: Group 2 - miconazole cream 2%; 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; Application of 1 gram on the lesion.; Other Names: Vodol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 14 days
Number of adverse events per participant	Number of adverse events, in each treatment group, including clinically relevant alterations of vital signs and laboratory tests.	up to 30 days

Collaborators and Investigators

• Sponsor: Galeno Desenvolvimento de Pesquisas Clínicas
• Collaborators: Biolab Sanus Farmaceutica

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 29, 2014
• Primary Completion (ACTUAL): December 10, 2014
• Study Completion (ACTUAL): May 6, 2015

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (ACTUAL): December 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2017
• Last Update Submitted That Met QC Criteria: November 27, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Tinea cruris; dapaconazole; topical antifungal; dermatophytoses
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Dermatitis; Skin Diseases, Eczematous; Dermatomycoses; Intertrigo; Tinea; Tinea cruris; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Clotrimazole; Miconazole
• Other Study ID Numbers: GDN 042/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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