Clinical trial
A Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of a Generic Butenafine Hydrochloride Cream, 1% and Reference Listed Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) and Compare Both Active Treatments to a Vehicle Control in the Treatment of Interdigital Tinea Pedis.
NCT01580878 is registered in ClinicalTrials.gov with Sun Pharmaceutical Industries, Inc. as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- A Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of a Generic Butenafine Hydrochloride Cream, 1% and Reference Listed Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) and Compare Both Active Treatments to a Vehicle Control in the Treatment of Interdigital Tinea Pedis.
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Phase
- Phase 1
- Overall status
- Completed
- Start date
- January 31, 2012
- Completion date
- December 31, 2012
- Enrollment
- 707 (actual)
- Sites
- Not reported
Conditions
As the registry lists them; a condition with its own page is linked.