The purpose of this study is to evaluate the efficacy and safety of NAFT-600, applied once daily for 2 weeks, when compared to placebo for 2 weeks in the treatment of subjects with tinea pedis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
855
Topical; applied once daily for two weeks
Topical; applied once daily for two weeks
Associated Foot & Ankle Specialists, LLC
Phoenix, Arizona, United States
Complete Cure of Interdigital Tinea Pedis
The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis. Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus.
Time frame: Visit 4/ Week 6
Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6
Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively). Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture.
Time frame: Visit 4/ Week 6.
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