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

Tinea Pedis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02606383
• Other study ID #: GDN 007/15
• Status: Withdrawn
• Phase: Phase 3
• First received: November 12, 2015
• Last updated: January 31, 2017
• Start date: June 2016

Study information

• Verified date: January 2017
• Source: Biolab Sanus Farmaceutica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

Intervention

Drug:
• Dapaconazole

• Ketoconazole

Locations

Country	Name	City	State
Brazil	Clínica Gobbato de Dermatologia	Rio Claro	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Biolab Sanus Farmaceutica

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and tolerability	Number of adverse events	45 days
Primary	Clinical cure of the lesion	Assessment of presence or absence of the lesion by clinical examination	14 days
Primary	Mycological cure of the lesion	Laboratory test for presence or absence of Tinea pedis	14 days
Secondary	Time (days) until clinical diagnosis of lesion cure		14 days