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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02606383
Other study ID # GDN 007/15
Secondary ID
Status Withdrawn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
Health authority
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Status Withdrawn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. completion date
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
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Terminated NCT02842021 - Efficacy and Safety of Product S2G6T-1in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis Phase 2
Completed NCT01712360 - Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis Phase 4
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Completed NCT01519752 - A Therapeutic Equivalence Study of Two Oxiconazole Nitrate Topical Cream Treatments for Patients With Tinea Pedis Phase 1
Completed NCT03320486 - Non-inferiority Trial of Dapaconazole Versus Ketoconazole Phase 3
Completed NCT01580891 - Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis Phase 1
Completed NCT01349998 - Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis Phase 3
Completed NCT01353976 - Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis Phase 3
Completed NCT04265521 - Study With BioCool Footcare in Subjects With Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet N/A
Completed NCT02633813 - BE Study of Naftifine HCL Phase 3
Recruiting NCT00856596 - Once a Day Topical Treatment for Athlete's Foot Fungus Inbetween the Toes in Males and Females Phase 3
Completed NCT00869336 - Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot) Phase 2
Completed NCT00768599 - A Study of Econazole Foam 1% in Athlete's Foot Phase 2
Recruiting NCT00233493 - Spread of Dermatophytes Among Families N/A
Completed NCT03897257 - A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis Phase 2
Completed NCT03129321 - Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis Phase 3
Completed NCT02335255 - Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis Phase 1