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Clinical Trial Comparing BL123 Versus Ketoconazole in Patients With Tinea Pedis

Primary Purpose

Tinea Pedis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Dapaconazole

Ketoconazole

About this trial

This is an interventional treatment trial for Tinea Pedis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dapaconazole

Ketoconazole

Arm Description

(cream; 2%; topical)

Outcomes

Primary Outcome Measures

Clinical cure of the lesion(s)

Assessment of presence or absence of lesion(s) by clinical examination

Mycological cure of the lesion(s)

Laboratory test for presence or absence of Tinea Pedis

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT02824926

First Posted

June 30, 2016

Last Updated

July 3, 2016

Sponsor

Gilberto De Nucci

Collaborators

Biolab Sanus Farmaceutica

1. Study Identification

Unique Protocol Identification Number

NCT02824926

Brief Title

Clinical Trial Comparing BL123 Versus Ketoconazole in Patients With Tinea Pedis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Gilberto De Nucci

Collaborators

Biolab Sanus Farmaceutica

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tinea Pedis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dapaconazole

Arm Type

Experimental

Arm Description

(cream; 2%; topical)

Arm Title

Ketoconazole

Arm Type

Active Comparator

Arm Description

(cream; 2%; topical)

Intervention Type

Drug

Intervention Name(s)

Dapaconazole

Intervention Type

Drug

Intervention Name(s)

Ketoconazole

Primary Outcome Measure Information:

Title

Clinical cure of the lesion(s)

Description

Assessment of presence or absence of lesion(s) by clinical examination

Time Frame

14 days

Title

Mycological cure of the lesion(s)

Description

Laboratory test for presence or absence of Tinea Pedis

Time Frame

14 days

Secondary Outcome Measure Information:

Title

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

Time Frame

14 days

Title

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

Time Frame

14 days

Other Pre-specified Outcome Measures:

Title

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

Description

Number of adverse events

Time Frame

45 days

Title

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

Description

Changes of laboratory parameters that are out of normal values/ranges and/or considered as clinically significant by the investigator.

Time Frame

45 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilberto De Nucci, PhD

Organizational Affiliation

Galeno Desenvolvimento de Pesquisas Ltda.

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

No IPD available.

Learn more about this trial

Clinical Trial Comparing BL123 Versus Ketoconazole in Patients With Tinea Pedis

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