NCT02606383

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

6 months

First QC Date

November 12, 2015

Last Update Submit

January 31, 2017

Conditions

Tinea Pedis

Outcome Measures

Primary Outcomes (2)

  • Clinical cure of the lesion

    Assessment of presence or absence of the lesion by clinical examination

    14 days

  • Mycological cure of the lesion

    Laboratory test for presence or absence of Tinea pedis

    14 days

Secondary Outcomes (1)

  • Time (days) until clinical diagnosis of lesion cure

    14 days

Other Outcomes (1)

  • Safety and tolerability

    45 days

Study Arms (2)

Dapaconazole

EXPERIMENTAL

Dapaconazole 2% Cream Topical

Drug: Dapaconazole

Ketoconazole

ACTIVE COMPARATOR

Ketoconazole 2% Cream Topical

Drug: Ketoconazole

Interventions

DapaconazoleDRUG
Also known as: BL123
Dapaconazole
KetoconazoleDRUG
Ketoconazole

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Gobbato de Dermatologia

Rio Claro, São Paulo, 13501-110, Brazil

Location

MeSH Terms

Conditions

Tinea Pedis

Interventions

1-(2-(2,4-dichlorophenyl)-2-(4-(trifluoromethyl)benzyloxy)ethyl)-1H-imidazoleKetoconazole

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousFoot DermatosesFoot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPruritusSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gilberto De Nucci, PhD

    Galeno Desenvolvimento de Pesquisas Ltda.

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2015

First Posted

November 17, 2015

Study Start

June 1, 2016

Primary Completion

December 1, 2016

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

BR(1)