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

Study Overview
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Brief Summary
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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.

Official Title
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A Double-blind, Randomized, Parallel-group, Vehicle-controlled, Multi-center Study to Evaluate the Safety and Clinical Equivalence of a Generic Ciclopirox Olamine Topical Suspension to Reference Ciclopirox Topical Suspension 0.77% in the Treatment of Tinea Pedis

Conditions
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Tinea Pedis

Intervention / Treatment
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* Drug: Ciclopirox Olamine Topical Suspension
* Drug: Ciclopirox Topical Suspension 0.77%-Reference Product
* Drug: Ciclopirox Olamine Topical Suspension-Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Product<br>Ciclopirox Olamine Topical Suspension | Drug: Ciclopirox Olamine Topical Suspension<br>* topical suspension<br>|
| Active Comparator: Reference Product<br>Loprox® Topical Suspension 0.77% | Drug: Ciclopirox Topical Suspension 0.77%-Reference Product<br>* topical suspension<br>|
| Placebo Comparator: Vehicle Product<br>placebo of test product | Drug: Ciclopirox Olamine Topical Suspension-Placebo<br>* topical suspension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects in Each Treatment Group With Therapeutic Success | Therapeutic success was defined as having both Mycological Cure (potassium hydroxide [KOH] wet mount negative and fungal culture negative) and Clinical Cure | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With Mycological Cure | Potassium hydroxide [KOH] wet mount negative and fungal culture negative | 6 weeks | 
| Proportion of Subjects With Clinical Cure | 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 | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tinea Pedis, Ciclopirox Olamine