Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis

Non-inferiority, Phase III Clinical Trial Comparing Dapaconazole Cream 2% (Biolab Sanus Farmacêutica Ltda.) Versus Ketoconazole Cream 2% (Nizoral® Janssen-Cilag) in Patients With Tinea Pedis

This is a non-inferiority, Phase III, open-label, randomized, parallel trial to evaluate the new intervention Dapaconazole cream 2% versus Ketoconazole cream 2% in patients with Tinea pedis. Sample size is 140 participants (70 per treatment group), male or female, aged between 16 and 60 years-old.

Primary objective is to evaluate non-inferiority of Dapaconazole cream 2% compared to Ketoconazole cream 2% in Tinea pedis treatment. Secondary objective is to evaluate safety and tolerability of Dapaconazole cream 2% after multiple administrations.

Participants will receive either new intervention or active control during 14 consecutive days, which will be followed by 2 follow-up visits.

Primary efficacy endpoint is clinical and mycological lesion cure, and secondary efficacy endpoint is time (days) until clinical diagnosis of lesion cure. Additionally, safety will be assessed by adverse events occurrence and laboratory exams evaluation.

Study Overview

• Status: Withdrawn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

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Rio Claro, São Paulo, Brazil, 13501-110
      • Clínica Gobbato de Dermatologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 56 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female study participants, aged between 16 and 60 years-old. Patients aged between 16 and 18 years-old will provide additional Assent Form before enrollment in the trial;
• Presence of a skin lesion characteristic of Tinea pedis, with diagnosis confirmed by direct mycological exam;
• Absence of previous antifungic treatment for the lesion under study;
• Absence of other significant diseases which, at the 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 measurements, physical examination and screening laboratory tests;
• Ability to understand the nature and objectives of the trial, including 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;
• Screening laboratory tests results showing clinically relevant deviations that, at the researcher discretion, prevent the subject to participate in the trial due to possible risks;
• Drugs addiction, including alcohol;
• Use of any previous treatment to the lesion under study that, according to principal investigator best judgement, might interfere in study objectives;
• Treatment, within 3 months before the 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;
• Pregnancy, labor or miscarriage with 12 weeks before study treatment;
• Any conditions, according to investigator's best judgement, that prevents the subject 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; Dapaconazole 2% Cream Topical	Drug: Dapaconazole; Other Names: BL123
Active Comparator: Ketoconazole; Ketoconazole 2% Cream Topical	Drug: Ketoconazole

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Time (days) until clinical diagnosis of lesion cure	14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability	Number of adverse events	45 days

Collaborators and Investigators

• Sponsor: Biolab Sanus Farmaceutica

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: November 12, 2015
• First Submitted That Met QC Criteria: November 14, 2015
• First Posted (Estimate): November 17, 2015

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

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 007/15