Trial Information

Open-label Study to Evaluate the Use of Imiquimod 5% Cream for Reducing Postsurgical Recurrence or Persistence of Basal Cell Carcinoma Following Excision by Curettage

This was an open-label, phase IIIb, multicenter, single arm, historical-controlled study.
Biopsy-confirmed BCC lesions (1 per subject) were excised by curettage, with no
electrodessication. Approximately 1 week later, treatment with imiquimod 5% cream was
initiated. Imiquimod was applied to the target BCC once daily, 5 times per week (5x/week)
for up to 6 weeks. Rest periods were allowed as needed. Subjects reported to the study
center at treatment weeks 1, 2, and 6, and posttreatment at weeks 12, 26, and 52. At
treatment week 6 and all posttreatment visits, the investigator clinically assessed the
target site for tumor clearance and cosmetic outcome. A template made at initiation and
created from clear plastic overlay aided in locating the target tumor site. If the
investigator identified a lesion that had occurred or recurred at the target site, the
subject was discontinued from the study and counted as a recurrence/persistence (R/P).