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Sponsored by: |
Perrigo Company |
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Information provided by: | Perrigo Company |
ClinicalTrials.gov Identifier: | NCT00804193 |
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.
Condition | Intervention |
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Tinea Pedis |
Drug: Ciclopirox Olamine Topical Suspension Drug: Ciclopirox Topical Suspension 0.77%-Reference Product Drug: Ciclopirox Olamine Topical Suspension-Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 553 |
Study Start Date: | June 2004 |
Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Test Product: Active Comparator | Drug: Ciclopirox Olamine Topical Suspension |
Reference Product: Active Comparator | Drug: Ciclopirox Topical Suspension 0.77%-Reference Product |
Vehicle Product: Placebo Comparator | Drug: Ciclopirox Olamine Topical Suspension-Placebo |
Ages Eligible for Study: | 10 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Perrigo Company ( Linda Gans ) |
Study ID Numbers: | CPL-402 |
Study First Received: | December 5, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00804193 |
Health Authority: | United States: Institutional Review Board |
Tinea Pedis Ciclopirox Olamine |
Pruritus Skin Diseases Clotrimazole Miconazole Tioconazole Foot Diseases Tinea Pedis |
Mycoses Signs and Symptoms Skin Diseases, Infectious Ciclopirox Tinea Dermatomycoses |
Anti-Infective Agents Skin Manifestations Foot Dermatoses Therapeutic Uses |
Antifungal Agents Infection Pharmacologic Actions |