Imiquimod 5% cream for the treatment of superficial basal cell carcinoma: results from two phase III, randomized, vehicle-controlled studies - 24/08/11
, Ivor Caro, MD b, Jane Lindholm, MD c, Loren Golitz, MD d, Patti Stampone, MS e, Mary Owens, MD eAbstract |
Background |
Imiquimod is an immune response modifier that is a Toll-like receptor 7 agonist that induces interferon and other cytokines through the innate immune system and stimulates cell-mediated immunity through T cells. Imiquimod has been shown to be efficacious as a topical treatment for basal cell carcinoma (BCC).
Objective |
We sought to evaluate the efficacy and safety of imiquimod 5% cream compared with vehicle for treating superficial BCC (sBCC).
Methods |
Two identical studies were conducted. Subjects with one sBCC were dosed with imiquimod or vehicle cream once daily 5 or 7×/week for 6 weeks in these 2 randomized, double-blind, vehicle-controlled Phase III studies. The lesion site was clinically examined 12 weeks posttreatment and then excised for histological evaluation.
Results |
Data from both studies were pooled. Composite clearance rates (combined clinical and histological assessments) for the 5 and 7×/week imiquimod groups were 75% and 73%, respectively. Histological clearance rates for the 5 and 7×/week imiquimod groups were 82% and 79%, respectively. Increasing severity of erythema, erosion, and scabbing/crusting was associated with higher clearance rates.
Conclusion |
Imiquimod appears to be safe and effective for the treatment of sBCC when compared with vehicle cream. The difference in clearance rates between the two imiquimod dosing groups was not significant. The 5×/week regimen is recommended.
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 | The two studies reported in this manuscript were funded by 3M Pharmaceuticals, St. Paul, Minn. Disclosure: Drs Geisse, Caro, Lindholm, and Golitz have been compensated by 3M Pharmaceuticals for their services in conducting the studies reported here. Dr Owens and Ms Stampone are employees of 3M Pharmaceuticals. Results from these studies have been presented at the congress of the American Academy of Dermatology, San Francisco, CA (March 2003), World Congress on Cancers of the Skin, Seville, Spain (May 2003), ASDS-ACMMSCO Combined Annual Meeting, New Orleans, La (October 2003), and the European Academy of Dermatology and Venereology, Barcelona, Spain (October 2003). |
Vol 50 - N° 5
P. 722-733 - mai 2004 Retour au numéro
Article précédent
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