Therapeutic response of basal cell carcinoma to the immune response modifier imiquimod 5% cream

Background: Basal cell carcinoma (BCC) responds to interferon therapy. Imiq uimod is a cytokine and interferon inducer Objective: This randomized, double-blind pilot trial evaluated the safety a nd efficacy of imiquimod 5% cream versus vehicle in the treatment of BCC. Methods: In this population of 35 patients with BCC, 24 received imiquimod 5% cream and 11 received vehicle cream in 1 of 5 dosing regimens for up to 16 weeks. Six weeks after treatment, an excisional biopsy of the target sit e was performed. Results: BCC cleared ton the basis of histologic examination) in all 15 pat ients (100%) dosed twice daily, once daily, and 3 times weekly; in 3 of 5 ( 60%) patients dosed twice weekly; 2 of 4 (50%) dosed once weekly; and in 1 of 11 (9%) treated with vehicle. Adverse events were predominantly local re actions at the target tumor site, with the incidence and severity of local skin reactions declining in groups dosed less frequently. Conclusion: Imiquimod 5% cream shows clinical efficacy in the treatment of BCC.