Non-inferiority Trial of Dapaconazole Versus Ketoconazole

Status Completed

Clinical Trial Summary

The main purpose of this study is to demonstrate that dapaconazole cream 2% (experimental drug) is non-inferior to ketoconazole cream 2% (Nizoral® - active comparator) for the treatment of dermatological lesions of Tinea pedis, when applied to the skin (topically) once daily during 28 days. Additionally, the safety and tolerability aspects will be evaluated in a descriptive way, through the observation of the incidence of adverse events.

Clinical Trial Description

This is a non-inferiority, phase 3, multicenter, double-blind, randomized (allocation of treatment), balanced, controlled (active comparator) trial, with two parallel groups in a 1:1 proportion.

Randomization will depend on inclusion/exclusion criteria, taking into account the confirmation of diagnosis by the direct mycological test performed during the screening phase. However, cases whose diagnosis is not additionally confirmed by positive fungal culture (sampled during the screening phase) will be excluded from the efficacy analysis.

Participants will show up to the clinic, for treatment, during 42 consecutive days, when one of the investigational products (according to the randomization) will be applied by a blind member of the study staff. A non-blind member of the study staff will weigh the corresponding investigational product and pass on to the blind member only a spatula with the weighed product, in order to maintain the blinded aspect of the trial.

For exploratory purposes, clinical and mycological evaluations will also be performed after 7 and after 14 days of treatment.

Safety analysis will be performed considering all the randomized patients to which at least one dose of the investigational products has been applied, regardless of the result of the fungal culture.

Conclusion of non-inferiority will be based on the per protocol set. It will be deemed as per protocol those participants who do not miss more than 20% of the applications and, also, no more than four consecutive application days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03320486
Study type	Interventional
Source	Biolab Sanus Farmaceutica
Contact
Status	Completed
Phase	Phase 3
Start date	November 1, 2017
Completion date	November 12, 2019

View Details

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
Completed	`NCT00781664` - Cumulative Irritation Test	Phase 1
Completed	`NCT03676686` - Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis	N/A
Completed	`NCT01519752` - A Therapeutic Equivalence Study of Two Oxiconazole Nitrate Topical Cream Treatments for Patients With Tinea Pedis	Phase 1
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
Withdrawn	`NCT02606383` - Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.