To assess the efficacy and safety of a combination product S2G6T-1 compared to its monads and vehicle, applied twice daily for 7 days, in the treatment of symptomatic inflammatory interdigital tinea pedis in subjects 12 years of age and older. The results of this study will be utilized to perform power calculations for the Phase 3 pivotal trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
283
TCR Medical Corporation
San Diego, California, United States
University Clinical Trials, Inc.
Complete cure at Day 29
The primary efficacy comparison between S2G6T-1 vs. rest of study arms will be based on the percentage of subjects at day 29 with complete cure of interdigital tinea pedis.mycological cure (i.e. negative dermatophyte culture and negative KOH) and clinical cure (i.e. absence of erythema, scaling and pruritus {scores of 0, each})
Time frame: Day 29
Reduction in Tinea pedis SymptomS through treatment period.
comparison of Patient Assessment between S2G6T-1 vs. rest of study arms will be based on the percentage of subjects at day 8 with achieving decrease from baseline in the total score for pruritus and burning.
Time frame: Day 8
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Twice a day topical cream
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