Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis
Information source: Perrigo Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tinea Pedis
Intervention: Ciclopirox Olamine Cream (Drug); Loprox Cream 0.77% (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Perrigo Company
Summary
The objectives of this study were to demonstrate comparable safety and efficacy of
Ciclopirox Olamine Cream (Test Product) and Ciclopirox Cream 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.
Clinical Details
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 Cream to Ciclopirox Cream 0.77% in the Treatment of Tinea Pedis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Proportion of Subjects in Each Treatment Group With Therapeutic Success
Secondary outcome: Proportion of Subjects With Mycological CureProportion of Subjects With Clinical Cure
Eligibility
Minimum age: 10 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 infecton 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
Locations and Contacts
Additional Information
Starting date: December 2003
Last updated: January 17, 2013
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