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September 2002

Efficacy of Topical 5% Imiquimod Cream for the Treatment of Nodular Basal Cell Carcinoma: Comparison of Dosing Regimens

Author Affiliations

From the St George Hospital, Kogarah, Australia (Dr Shumack); Loyola University Medical Center, Maywood, Ill (Dr Robinson); the Skin and Cancer Foundation Australia, Darlinghurst (Dr Kossard); Dermatopathology Services, LLC, Denver, Colo (Dr Golitz); the Scripps Clinic, La Jolla, Calif (Dr Greenway); the Mayo Clinic, Rochester, Minn (Dr Schroeter); 3M Pharmaceuticals, St Paul, Minn (Ms Andres and Dr Owens); and 3M Health Care, Thornleigh, (Dr Amies).

Arch Dermatol. 2002;138(9):1165-1171. doi:10.1001/archderm.138.9.1165

Objective  To establish a safe and efficacious dosing regimen for the treatment of primary nodular basal cell carcinoma (BCC) using 5% imiquimod cream.

Design  Two phase 2 studies were conducted: a 6-week, randomized, open-label, dose-response study evaluating 4 dosing regimens and a 12-week, randomized, vehicle-controlled, double-blind, dose-response study evaluating 4 dosing regimens.

Setting  Twenty-four public and private dermatology clinics in Australia and New Zealand (6-week study) and the United States (12-week study) participated.

Patients  The study populations comprised 99 patients enrolled in the 6-week study and 92 patients in the 12-week study. Patients were at least 18 years old and had a biopsy-confirmed diagnosis of nodular BCC.

Interventions  In the 6-week study, imiquimod was applied once daily for 3 or 7 days per week or twice daily for 3 or 7 days per week. In the 12-week study, imiquimod or placebo cream (vehicle) was applied once daily for 3, 5, or 7 days per week, or twice daily for 7 days per week. The entire tumor area was excised 6 weeks after treatment and examined histologically for evidence of remaining BCC.

Main Outcome Measure  The proportion of patients having no histologic evidence of BCC in the posttreatment excision specimen.

Results  Dosing once daily for 7 days per week resulted in the highest clearance rate, with 25 (71%) of 35 and 16 (76%) of 21 patients showing clearance of their tumor in the 6- and 12-week studies, respectively.

Conclusions  Topical 5% imiquimod cream is well tolerated and most effective in treating nodular BCC when applied once daily for 7 days per week for either 12 or 6 weeks.