Clinical Trial Comparing BL123 Versus Ketoconazole in Patients With Tinea Pedis

Non-inferiority Phase II Trial Comparing BL123 (Biolab Sanus Farmacêutica Ltda.) Versus Ketoconazole (Nizoral® Janssen-Cilag) in Patients With Tinea Pedis

This is a non-inferiority, Phase II, open-label, randomized, parallel trial to evaluate efficacy and safety of the new intervention (Dapaconazole cream 2%) versus the active control (Ketoconazole cream 2%) in patients with Tinea Pedis. Study schedule comprises enrollment, treatment and follow-up visits. Treatment period is 14 days.

Study Overview

• Status: Completed
• Conditions: Tinea Pedis
• Intervention / Treatment: Drug: Ketoconazole; Drug: Dapaconazole

Detailed Description

The study sample consists of male and female subjects aged between 18 and 60 years-old, either with single or multiple Tinea Pedis lesion(s). Sixty (60) patients will be enrolled, but each foot with lesion(s) will be considered as one (1) sample. Therefore, if a patient has bilateral lesions, one foot will be allocated to investigational product (Dapaconazole) and the other foot will be allocated to active control (Ketoconazole). Randomization will determine which foot (right or left) will be treated with Dapaconazole or Ketoconazole.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

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:

• Male or female subjects, aged between 18 and 60 years-old;
• Presence of skin lesion(s) characteristic of Tinea Pedis, with diagnosis confirmed by direct mycological exam;
• Absence of previous antifungic treatment for the current lesion(s) under study;
• Absence of other significant diseases which, at physician's discretion, could have an impact on subject's participation in the trial, according to protocol requirements and study evaluations: medical history, blood pressure and heart rate, physical examination and screening laboratory tests;
• Ability to understand the nature and objectives of the trial, including its risks and adverse events; willingness to cooperate with the researcher and proceed according to all study requirements, which shall be confirmed by Informed Consent Form signature.

Exclusion Criteria:

• Known hypersensitivity to ketoconazole or chemically related compounds; history of serious adverse reactions;
• Current evidence of clinically significant diseases which, at physician's discretion, prevent subject's participation in the trial and/or expose the subject to risks other than what is normally expected;
• Use of medications that, at principal investigator's discretion, might expose the subject to risks other than what is normally expected;
• Screening laboratory tests results showing clinically relevant deviations that, due to potential risks, prevent participation in the trial, at the researcher's discretion;
• Drugs addiction, including alcohol;
• Use of any previous treatment to the lesion(s) under study that, according to principal investigator's discretion, might interfere with the study objectives;
• Treatment, within 3 months before this trial, with any drugs known to have a well-established toxic potential to major organs;
• Participation in any other experimental research or administration of any experimental drug within 6 months before this trial;
• Positive pregnancy test, labor or miscarriage within 12 weeks before study treatment;
• Any conditions, according to investigator's discretion, that prevent subjects to participate in the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dapaconazole; (cream; 2%; topical)	Drug: Dapaconazole
Active Comparator: Ketoconazole; (cream; 2%; topical)	Drug: Ketoconazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical cure of the lesion(s)	Assessment of presence or absence of lesion(s) by clinical examination	14 days
Mycological cure of the lesion(s)	Laboratory test for presence or absence of Tinea Pedis	14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Time (days) to clinical diagnosis of lesion(s) cure	14 days
Time (days) to absence of itching at lesion(s) site	14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Number of adverse events	45 days
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Changes of laboratory parameters that are out of normal values/ranges and/or considered as clinically significant by the investigator.	45 days

Collaborators and Investigators

• Sponsor: Gilberto De Nucci
• Collaborators: Biolab Sanus Farmaceutica

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: June 30, 2016
• First Submitted That Met QC Criteria: July 3, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Estimate): July 7, 2016
• Last Update Submitted That Met QC Criteria: July 3, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea; Tinea Pedis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; 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; Ketoconazole
• Other Study ID Numbers: GDN 083/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: No IPD available.