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I read on https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20723s016lbl.pdf (mirror):

364 patients with primary superficial basal cell carcinoma (sBCC) were treated with Aldara Cream or vehicle cream 5X/week for 6 weeks. Patients with one biopsy-confirmed sBCC tumor were enrolled and randomized in a 1:1 ratio to active or vehicle treatment. Target tumors were to have a minimum area of 0.5 cm2 -and a maximum diameter of 2.0 cm (4.0 cm2 ). Target tumors were not to be located within 1.0 cm of the hairline, eyes, nose, mouth, ears, on the anogenital area or on the hands or feet, or have any atypical features. On a scheduled dosing day, the study cream was applied to the target tumor and approximately 1 cm (about 1/3 inch) beyond the target tumor prior to normal sleeping hours; 5X/week dosing was continued for a total of 6 weeks.

Should Imiquimod 5% cream (US brand: Aldara) be applied 1 cm beyond the target tumor when treating a facial basal cell carcinoma (BCC), and if so, why?

1 cm sounds quite large to me when the tumor is less than 1cm².

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  • How has tumor size impact on spread diameter? Seems purely opinion-based.
    – Thomas
    Nov 16 '20 at 19:08
  • @Thomas Why do you think it is opinion-based? Purely factual as far as I can see. Also, regarding "How has tumor size impact on spread diameter?", I don't know what you mean, the question is asking about the margin of application beyond the tumor. Nov 16 '20 at 19:32
  • I was referring to "1 cm sounds quite large to me when the tumor is less than 1cm²". Seems coincidental or opinion-based, unless you have any less subjective reference for that?
    – Thomas
    Nov 16 '20 at 20:02
  • @Thomas if the tumor is 1cm² then a 1cm margin means the total application area will be 9 times more, assuming a square rumor. Hence the 1cm margin seems quite large. The core of the question is simply asking where the 1cm rule comes from, or should a different margin be used. Nov 16 '20 at 20:20

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