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
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
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.
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