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Clinical Trial Summary

To demonstrate comparable safety and efficacy of Taro Pharmaceuticals, Inc butenafine hydrochloride cream 1% test product and Lotrimin Ultra cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01119742
Study type Interventional
Source Taro Pharmaceuticals USA
Contact
Status Terminated
Phase Phase 1
Start date July 2010
Completion date July 2011

See also
  Status Clinical Trial Phase
Completed NCT01696799 - Comparative PK Study of Econazole Nitrate Foam and Econazole Nitrate Cream in Subjects With Interdigital Tinea Pedis Aged 12 Years to Less Than 18 Years Phase 2
Terminated NCT04315051 - A Trial of Safety/Efficacy of Test Article in Patients With Interdigital T. Pedis Phase 2