TherapyImiquimod 5% cream in the treatment of superficial basal cell carcinoma: Results of a multicenter 6-week dose-response trial☆,☆☆,★,★★,♢
Section snippets
Methods
A randomized, dose-frequency, open-label study was conducted at 9 sites in Australia and 1 site in New Zealand. Institutional Ethics Committees for each site approved the study; men and women aged 18 years and older were recruited with a biopsy specimen histologically confirming an sBCC located on the head, neck, trunk, or limbs. Tumors on areas within 1 cm of the hairline, eyes, nose, mouth, ears, anogenital region, hands, and feet were excluded. Lesions with a surface area of between 0.5 and
Study patients
A total of 99 patients, 72 men and 27 women with a mean age of 61 years (range, 23-83 years) were recruited and received the study drug. All patients were white; 46% had Fitzpatrick skin type II (tans minimally) and 32% had skin type III (tans gradually). Thirty-two (32%) of the tumors were on the upper limbs, 14 (14%) were on the upper anterior trunk, 14 (14%) were on the upper posterior trunk, with the remainder occurring on the head and neck and lower limbs. Two patients were enrolled with a
Discussion
This study confirms previous work suggesting that imiquimod 5% cream is likely to be of value in the treatment of sBCC.6 There was an almost 90% histologic clearance of these tumors when the cream was applied daily for 6 weeks.
In the study by Beutner et al,7 a 100% response rate was achieved using treatment for up to 16 weeks.6 In their study, the median treatment time was 10 weeks for the twice-daily application arm, 13 weeks for the once-daily arm, and 14.5 weeks for the 3-times-weekly arm.
Acknowledgements
We thank the following persons who assisted in undertaking this study at various centers throughout Australia and New Zealand: Ms Candy Murray, Ms Beverley Underwood, and Drs Paul Chee, Alvin Chong, Derek Davies, Dennis Koutis, Adrian Lim, and Martin Wade.
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2021, Gynecologic OncologyCitation Excerpt :The FDA-approved use of imiquimod for basal cell carcinoma is five times a week [18,41]. In the early studies of basal cell carcinoma, the daily administration of imiquimod was also conducted [48]. Several limitations of this study should be noted.
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2020, Photodiagnosis and Photodynamic TherapyCitation Excerpt :Imiquimod acts to induce immune responses mediated by innate and adaptive cells and might be an immune-response modifier [51]. Several studies have indicated the benefit of topical imiquimod in the treatment of superficial BCC is associated with a significant inflammatory reaction [52,53]. Treatment with fluorouracil was associated with eczematous reactions, ulceration, and erosion [54].
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This study was initiated by and supported with a grant from 3M Pharmaceuticals, St Paul, Minn.
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Mark Amies, James Bryden, Terry Fox, and Mary Owens are all employees of 3M Pharmaceuticals; Robin Marks, Kurt Gebauer, Stephen Shumack, and the other members of the Australasian Multi-Centre Trial Group have no corporate affiliations with 3M Pharmaceuticals.
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*The Australasian Multicentre Trial Group: Drs Nicholas Birchall, Geoffrey Cains, Judith Cole, Kurt Gebauer, Robin Marks, Christopher Quirk, Stephen Shumack, Rodney Sinclair, Karen Stapleton, Alan Watson. Dermatopathologists: Drs Steven Kossard, Peter Heenan.
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Reprint requests: Professor Robin Marks, Department of Dermatology, St Vincent's Hospital, 41 Victoria Parade, Fitzroy 3065, Victoria, Australia.
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J Am Acad Dermatol 2001;44:807-13