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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02606383
• Date of registration: 12/11/2015
• Prospective Registration: Yes
• Primary sponsor: Biolab Sanus Farmaceutica
• Public title: Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis
• Scientific 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
• Date of first enrolment: June 2016
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02606383
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Brazil

Contacts

• Name: Gilberto De Nucci, PhD
• Affiliation: Galeno Desenvolvimento de Pesquisas Ltda.

Key inclusion & exclusion 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.



Age minimum: 16 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Tinea Pedis

Intervention(s)

Drug: Ketoconazole

Drug: Dapaconazole

Primary Outcome(s)

Clinical cure of the lesion [Time Frame: 14 days]

Mycological cure of the lesion [Time Frame: 14 days]

Secondary Outcome(s)

Time (days) until clinical diagnosis of lesion cure [Time Frame: 14 days]

Secondary ID(s)

GDN 007/15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors