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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

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 Topical Suspension (Drug); Ciclopirox Topical Suspension 0.77%-Reference Product (Drug); Ciclopirox Olamine Topical Suspension-Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Perrigo Company


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.

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 Topical Suspension to Reference Ciclopirox Topical Suspension 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 Cure

Proportion of Subjects With Clinical Cure


Minimum age: 10 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Locations and Contacts

Additional Information

Starting date: June 2004
Last updated: January 9, 2014

Page last updated: August 23, 2015

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