NCT00189306

Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream

An Open-label Study to Evaluate the Safety and Long-Term Clinical Efficacy of Imiquimod 5% Cream Applied Once Daily 7 Days Per Week for 6 Weeks in the Treatment of Superficial Basal Cell Carcinoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Graceway Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open-label study to evaluate the safety and the ability of Imiquimod 5% cream, applied topically, to clear superficial basal cell carcinoma and to keep it clear for 5 years of follow-up.

Detailed description

Evaluate the long-term sustained clearance rate, defined as the proportion of those subjects clinically clear of basal cell carcinoma (BCC) at the treated superficial BCC (sBCC) target tumor site at the 12-week posttreatment visit who remain clear during a 5 year follow-up period.

Conditions

• Superficial Basal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Imiquimod 5% cream	Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks

Timeline

• Start date: 2001-03-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2005-09-19
• Last updated: 2010-08-10
• Results posted: 2008-11-26

Locations

18 sites across 2 countries: Australia, New Zealand