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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
553
topical suspension
topical suspension
topical suspension
Proportion of Subjects in Each Treatment Group With Therapeutic Success
Therapeutic success was defined as having both Mycological Cure (potassium hydroxide \[KOH\] wet mount negative and fungal culture negative) and Clinical Cure
Time frame: 6 weeks
Proportion of Subjects With Mycological Cure
Potassium hydroxide \[KOH\] 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
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