Clinical Trials Logo
  1. Home
  2. Tinea Pedis
  3. NCT02824926

Clinical Trial Comparing BL123 Versus Ketoconazole in Patients With Tinea Pedis

Tinea Pedis Clinical Trial

Official title:
Non-inferiority Phase II Trial Comparing BL123 (Biolab Sanus Farmacêutica Ltda.) Versus Ketoconazole (Nizoral® Janssen-Cilag) in Patients With Tinea Pedis

Clinical Trial Summary

This is a non-inferiority, Phase II, open-label, randomized, parallel trial to evaluate efficacy and safety of the new intervention (Dapaconazole cream 2%) versus the active control (Ketoconazole cream 2%) in patients with Tinea Pedis. Study schedule comprises enrollment, treatment and follow-up visits. Treatment period is 14 days.

Clinical Trial Description

The study sample consists of male and female subjects aged between 18 and 60 years-old, either with single or multiple Tinea Pedis lesion(s). Sixty (60) patients will be enrolled, but each foot with lesion(s) will be considered as one (1) sample. Therefore, if a patient has bilateral lesions, one foot will be allocated to investigational product (Dapaconazole) and the other foot will be allocated to active control (Ketoconazole). Randomization will determine which foot (right or left) will be treated with Dapaconazole or Ketoconazole. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02824926
Study type Interventional
Source Galeno Desenvolvimento de Pesquisas Clínicas
Contact
Status Completed
Phase Phase 2
Start date July 2014
Completion date January 2015
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05493488 - A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Tinea Pedis Phase 2
Completed NCT04883593 - A Study Comparing the Efficacy of TA103 and the Placebo Control in the Treatment of Interdigital Tinea Pedis. Early Phase 1
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 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 NCT01353976 - Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis Phase 3
Completed NCT01349998 - Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis 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