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
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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)
Number of participants clinically clear of superficial basal cell carcinoma at the treated target tumor site at the 12-week posttreatment visit (ie, initial clearance rate) who remain clear during a 5 year follow-up period.
Jim Lee, Dr.
United States: Food and Drug Administration