Cutis
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Multicenter Study
Sustained clearance of superficial basal cell carcinomas treated with imiquimod cream 5%: results of a prospective 5-year study.
We conducted a prospective, multicenter, phase 3, open-label study to assess long-term sustained clearance of superficial basal cell carcinomas (sBCCs) treated with imiquimod cream 5%. A biopsy-confirmed tumor (area > or = 0.5 cm2 and diameter < or = 2.0 cm) was treated once daily 7 times per week for 6 weeks. Participants with initial clinical clearance at 12 weeks posttreatment were followed for 60 months. ⋯ Local skin reactions and application site reactions, the AEs reported by the most participants, occurred predominantly during the treatment period and resolved posttreatment. Compared to baseline, investigator-assessed SQA scores for the target tumor site improved for skin surface abnormalities and hyperpigmentation, and worsened for hypopigmentation. For low-risk sBCCs, daily application of imiquimod for 6 weeks had high initial and 5-year sustained clearance rates.