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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
561
Proportion of Subjects in Each Treatment Group With Therapeutic Success
Both Mycological Cure (KOH wet mount negative and fungal culture negative) and Clinical Cure were required to achieve Therapeutic Success
Time frame: 6 weeks
Proportion of Subjects With Mycological Cure
Mycological Cure (KOH wet mount negative and fungal culture negative
Time frame: 6 weeks
Proportion of Subjects With Clinical Cure
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
Time frame: 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.