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

Padagis

Status: Completed

Conditions: Tinea Pedis

Treatments: Drug: Ciclopirox Olamine Topical Suspension; Drug: Ciclopirox Olamine Topical Suspension-Placebo; Drug: Ciclopirox Topical Suspension 0.77%-Reference Product

Study type: Interventional

Funder types: Industry

Identifiers

NCT00804193

CPL-402

Details and patient eligibility

About

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.

Enrollment: 553 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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553 participants in 3 patient groups, including a placebo group

Test Product

Experimental group

Description:

Ciclopirox Olamine Topical Suspension

Treatment:

Drug: Ciclopirox Olamine Topical Suspension

Reference Product

Active Comparator group

Description:

Loprox® Topical Suspension 0.77%

Treatment:

Drug: Ciclopirox Topical Suspension 0.77%-Reference Product

Vehicle Product

Placebo Comparator group

Description:

placebo of test product

Treatment:

Drug: Ciclopirox Olamine Topical Suspension-Placebo