Clinical Trial Comparing BL123 Versus Ketoconazole in Patients With Tinea Pedis

NCT02824926 | Completed Phase 2

• 1 other identifier: GDN 083/13
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Tinea Pedis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Time (days) to clinical diagnosis of lesion(s) cure

  14 days

• Time (days) to absence of itching at lesion(s) site

  14 days

Other Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  45 days

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  45 days

Study Arms (2)

Dapaconazole

EXPERIMENTAL

(cream; 2%; topical)

Drug: Dapaconazole

Ketoconazole

ACTIVE COMPARATOR

(cream; 2%; topical)

Drug: Ketoconazole

Interventions

Dapaconazole DRUG

Dapaconazole

Ketoconazole DRUG

Ketoconazole

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilberto De Nucci: lead
• Biolab Sanus Farmaceutica: collaborator

MeSH Terms

Conditions

Tinea Pedis

Interventions

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

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gilberto De Nucci, PhD

  Galeno Desenvolvimento de Pesquisas Ltda.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 7, 2016
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: July 7, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share