NCT00175643

Safety and Efficacy of Imiquimod Applied in Dose-Cycle for Actinic Keratoses

Open-Label Study to Assess Safety and Efficacy of Imiquimod 5% Cream Applied 3 Days Per Week in 1 or 2 Cycles for Treatment of Actinic Keratoses on the Head

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

It is believed that imiquimod 5% cream has the potential to be an effective treatment for actinic keratoses. The purpose of this study is to evaluate the duration of the effect of topical imiquimod 5% topical cream for the treatment of actinic keratoses.

Detailed description

This study will assess the safety and efficacy of imiquimod 5% cream applied to actinic keratoses on the head to reduce the size of lesions. The objective is to analyze the effect of dose cycling with respect to the complete clearance rate when imiquimod 5% cream is applied 3 times per week for 4 weeks in 1 or 2 cycles. The complete clearance rate is defined as the proportion of subjects with no clinically visible AK lesions in the treatment area at the end of cycle 1 or the end of cycle 2.

Conditions

• Actinic Keratoses

Interventions

Type	Name	Description
DRUG	imiquimod

Timeline

• Start date: 2005-02-01
• Completion: 2005-11-01
• First posted: 2005-09-15
• Last updated: 2006-05-09

Locations

1 site across 1 country: Canada