Evaluate the Safety & Bioequivalence of a Generic Butenafine Cream & Lotrimin Ultra® & Compare Both to a Vehicle Control in Treatment of Interdigital Tinea Pedis

PHASE1CompletedINTERVENTIONAL
Enrollment

707

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

August 31, 2012

Study Completion Date

December 31, 2012

Conditions
Tinea Pedis
Interventions
DRUG

Butenafine Hydrochloride Cream, 1%

Butenafine Hydrochloride Cream, 1% applied twice daily for 7 consecutive days

DRUG

Lotrimin Ultra®

Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) applied twice daily for 7 consecutive days.

DRUG

Butenafine Vehicle

Butenafine Vehicle applied twice daily for 7 consecutive days.

All Listed Sponsors
lead

Sun Pharmaceutical Industries, Inc.

INDUSTRY

NCT01580878 - Evaluate the Safety & Bioequivalence of a Generic Butenafine Cream & Lotrimin Ultra® & Compare Both to a Vehicle Control in Treatment of Interdigital Tinea Pedis | Biotech Hunter | Biotech Hunter