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

Not Applicable

Completed

• Conditions: Tinea Pedis
• Interventions: Drug: Ciclopirox Topical Suspension 0.77%-Reference Product; Drug: Ciclopirox Olamine Topical Suspension-Placebo; Drug: Ciclopirox Olamine Topical Suspension

• Registration Number: NCT00804193
• Lead Sponsor: Padagis LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2004-12
• Study Completion: 2005-04
• Study First Submitted: 2008-12-05
• Study First Submitted QC: 2008-12-05
• Study First Posted: 2008-12-08
• Results First Submitted: 2012-09-10
• Results First Submitted QC: 2012-11-19
• Results First Posted: 2012-12-17
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-11
• Last Update Posted: 2021-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 553

Inclusion Criteria

• Male or female at least 10 years of age, and otherwise healthy
• Clinically and mycologically confirmed diagnosis of symptomatic tinea pedis
• In good health with no clinically significant disease that might have interfered with study evaluations
• Study participant or legal guardian was willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol. For subjects 10 to 17 years of age, an assent form for minors was completed.

Exclusion Criteria

• History of hypersensitivity or allergy to ciclopirox
• Had any skin condition that would interfere with the diagnosis or assessment of tinea pedis
• Had a history of dermatophyte infection unresponsive to antifungal treatment
• Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study
• Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk
• Was unwilling to sign the informed consent
• Female who was pregnant or lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference Product	Ciclopirox Topical Suspension 0.77%-Reference Product	Loprox® Topical Suspension 0.77%
Vehicle Product	Ciclopirox Olamine Topical Suspension-Placebo	placebo of test product
Test Product	Ciclopirox Olamine Topical Suspension	Ciclopirox Olamine Topical Suspension

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects in Each Treatment Group With Therapeutic Success	6 weeks	Therapeutic success was defined as having both Mycological Cure (potassium hydroxide \[KOH\] wet mount negative and fungal culture negative) and Clinical Cure

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects With Mycological Cure	6 weeks	Potassium hydroxide \[KOH\] wet mount negative and fungal culture negative
Proportion of Subjects With Clinical Cure	6 weeks	Clinical Cure was defined as a signs and symptoms score of \<1 for erythema; \<1 for scaling; and 0 for pruritus, maceration, fissuring/cracking, and burning/stinging; as well as an assessment that no additional antifungal therapy was required to treat the subject's current episode of tinea pedis