Back to resultsNon-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis
Primary Purpose
Tinea Pedis
Status
Withdrawn
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Dapaconazole
Ketoconazole
Sponsored by
About this trial
This is an interventional treatment trial for Tinea Pedis
Eligibility Criteria
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.
Sites / Locations
- Clínica Gobbato de Dermatologia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dapaconazole
Ketoconazole
Arm Description
Dapaconazole 2% Cream Topical
Ketoconazole 2% Cream Topical
Outcomes
Primary Outcome Measures
Clinical cure of the lesion
Assessment of presence or absence of the lesion by clinical examination
Mycological cure of the lesion
Laboratory test for presence or absence of Tinea pedis
Secondary Outcome Measures
Time (days) until clinical diagnosis of lesion cure
Full Information
NCT ID
NCT02606383
First Posted
November 12, 2015
Last Updated
January 31, 2017
Sponsor
Biolab Sanus Farmaceutica
1. Study Identification
Unique Protocol Identification Number
NCT02606383
Brief Title
Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biolab Sanus Farmaceutica
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dapaconazole
Arm Type
Experimental
Arm Description
Dapaconazole 2% Cream Topical
Arm Title
Ketoconazole
Arm Type
Active Comparator
Arm Description
Ketoconazole 2% Cream Topical
Intervention Type
Drug
Intervention Name(s)
Dapaconazole
Other Intervention Name(s)
BL123
Intervention Type
Drug
Intervention Name(s)
Ketoconazole
Primary Outcome Measure Information:
Title
Clinical cure of the lesion
Description
Assessment of presence or absence of the lesion by clinical examination
Time Frame
14 days
Title
Mycological cure of the lesion
Description
Laboratory test for presence or absence of Tinea pedis
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Time (days) until clinical diagnosis of lesion cure
Time Frame
14 days
Other Pre-specified Outcome Measures:
Title
Safety and tolerability
Description
Number of adverse events
Time Frame
45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
Facility Information:
Facility Name
Clínica Gobbato de Dermatologia
City
Rio Claro
State/Province
São Paulo
ZIP/Postal Code
13501-110
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis
We'll reach out to this number within 24 hrs