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Safety and Equivalence of a Generic Ciclopirox Olamine Topical Suspension Compared to the Reference Ciclopirox Topical Suspension 0.77% for the Treatment of Tinea Pedis

NCT00804193 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 553

Last updated 2021-10-27

Study results available
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Summary

The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Topical Suspension (Test Product) and Ciclopirox Topical Suspension 0.77% (Reference Product) in the treatment of subjects with tinea pedis, and to show the superiority of the active treatments over that of the vehicle.

Conditions

  • Tinea Pedis

Interventions

DRUG

Ciclopirox Olamine Topical Suspension

topical suspension

DRUG

Ciclopirox Topical Suspension 0.77%-Reference Product

topical suspension

DRUG

Ciclopirox Olamine Topical Suspension-Placebo

topical suspension

Sponsors & Collaborators

  • Padagis LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2004-12-31
Completion
2005-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00804193 on ClinicalTrials.gov