NCT00859105

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

A Multicenter, Double-Blind, Vehical-Controlled Study Comparing Imiquimod Cream, 5% (Apotex Inc.) to Aldara™ Cream, 5%(3M Pharmaceutials, U.S.) and Aldara™ Cream, 5%(3M Pharmaceuticals, Canada) in the Treatments of Actinic Keratosis.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 497 (actual)
• Sponsor: Apotex Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Bio-equivalence Study

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-11-01
• First posted: 2009-03-10
• Last updated: 2009-03-10