A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Therapeutic Equivalence Study of Three Imiquimod Cream 5% Treatments for Patients With Actinic Keratosis

PHASE3CompletedINTERVENTIONAL
Enrollment

497

Participants

Timeline

Start Date

February 29, 2008

Primary Completion Date

November 30, 2008

Conditions
Actinic Keratosis
Interventions
DRUG

Imiquimod 5%: manufactured by Apotex

Treatment applied as a thin layer to target area once a day, 2 days each week, 16 weeks

DRUG

Adara 5% Cream US

Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks

DRUG

Adara 5% Cream Canada

Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks.

DRUG

Imiquimod Vehicle

Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Apotex Inc.

INDUSTRY