NCT00828568

Bioequivalence Study of Two Imiquimod Cream 5%

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 425 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%, manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M, and to show superiority over vehicle in the treatment of AK. The secondary objective is to compare the adverse event (AE) profiles of the two creams.

Conditions

• Actinic Keratosis

Interventions

Type	Name	Description
DRUG	Imiquimod 5% manufactured by Taro	Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
DRUG	Aldara - Imiquimod 5%	Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks
DRUG	Imiquimod Vehicle manufactured by Taro	Treatment applied as a thin layer to target area once daily, 2 days each week, for 16 weeks

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-03-01
• Completion: 2009-05-01
• First posted: 2009-01-26
• Last updated: 2014-01-28
• Results posted: 2009-11-26

Locations

20 sites across 1 country: United States