Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis
- Conditions
- Tinea Pedis
- Interventions
- Registration Number
- NCT00802672
- Lead Sponsor
- Padagis LLC
- 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 with tinea pedis, and to show the superiority of the active treatments over that of the vehicle.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 561
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test Product Ciclopirox Olamine Cream Ciclopirox Olamine Cream 0.77% Reference Product Loprox Cream 0.77% Loprox Cream 0.77% Vehicle Product Placebo placebo of test product
- Primary Outcome Measures
Name Time Method Proportion of Subjects in Each Treatment Group With Therapeutic Success 6 weeks Both Mycological Cure (KOH wet mount negative and fungal culture negative) and Clinical Cure were required to achieve Therapeutic Success
- Secondary Outcome Measures
Name Time Method Proportion of Subjects With Mycological Cure 6 weeks Mycological Cure (KOH wet mount negative and fungal culture negative
Proportion of Subjects With Clinical Cure 6 weeks Clinical Cure was defined as a signs and symptoms score of \<1 for erythema; \<1 for scaling; and 0 for pruritus, maceration, fissuring/cracking, and burning/stinging; as well as an assessment that no additional antifungal therapy was required to treat the subject's current episode of tinea pedis