Clinical Study to Evaluate the Bioequivalence of Two Imiquimod Cream 3.75% Formulations in Patients With Actinic Keratosis.

PHASE1CompletedINTERVENTIONAL
Enrollment

443

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

October 31, 2013

Study Completion Date

December 31, 2013

Conditions
Actinic Keratosis
Interventions
DRUG

Imiquimod Topical Cream 3.75%

Imiquimod Topical Cream 3.75% (Taro Pharmaceutical Industries Ltd.) applied once daily for two 14 day treatment cycles separated by a 14 day no treatment period.

DRUG

Zyclara® (imiquimod) Topical Cream 3.75%

Zyclara® (imiquimod) Topical Cream 3.75% (Medicis Pharmaceutical Co.) applied once daily for two 14 day treatment cycles separated by a 14 day no treatment period.

DRUG

Vehicle Topical Cream

Vehicle Topical Cream (Taro Pharmaceutical Industries Ltd.) applied once daily for two 14 day treatment cycles separated by a 14 day no treatment period.

All Listed Sponsors
lead

Sun Pharmaceutical Industries, Inc.

INDUSTRY

NCT01788007 - Clinical Study to Evaluate the Bioequivalence of Two Imiquimod Cream 3.75% Formulations in Patients With Actinic Keratosis. | Biotech Hunter | Biotech Hunter