Status:
COMPLETED
Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis
Lead Sponsor:
Padagis LLC
Conditions:
Tinea Pedis
Eligibility:
All Genders
10+ years
Phase:
PHASE3
Brief 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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
561 Patients enrolled
Trial Details
Trial ID
NCT00802672
Start Date
December 1 2003
End Date
May 1 2004
Last Update
October 13 2021
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