ReportImiquimod 5% cream for the treatment of superficial basal cell carcinoma: results from two phase III, randomized, vehicle-controlled studies☆
Section snippets
Methods
Two identical, multicenter, randomized, double-blind, vehicle-controlled, dose-response studies were initiated at 55 centers in the United States. All protocols and informed consent documents were submitted to and approved by each study center's institutional review board. Before study procedures were initiated, each subject voluntarily signed an informed consent form.
Subject disposition and demographics
A total of 724 subjects were enrolled into the combined studies. Thirty-two subjects discontinued during the treatment period and 13 subjects discontinued from the posttreatment period. One of these subjects discontinued from the treatment period, went on to the posttreatment period, and subsequently discontinued from the posttreatment period. Fig 1 displays subject disposition during the study.
In the ITT group, 279 (39%) subjects were female and 445 (61%) were male. The subject population
Clearance rates
Based on the ITT population, the composite clearance rates for the 5×/week and 7×/week imiquimod groups were 75% (95% CI: 68-81%) and 73% (95% CI: 66-79%), respectively (Fig 2). A total of 32 subjects were considered nonresponders due to either a missing endpoint assessment (26 subjects) or who were inadvertantly entered into the study without a histologic diagnosis of sBCC (6 subjects). Clearance rates based solely on histology data for the 5×/week and 7×/week imiquimod groups were somewhat
Adverse events
The incidence of AEs during the treatment period was higher than during the posttreatment period. During the treatment period, 58% of subjects in the 5×/week imiquimod group and 64% of subjects in the 7×/week imiquimod group and 36% of subjects in the combined vehicle groups experienced at least 1 adverse event. The proportion of subjects in the 5×/week and 7×/week vehicle groups who reported at least 1 AE during the posttreatment period were 33% and 31%, respectively. A total of 7 (4%)
Discussion
The results from these Phase III studies confirm that imiquimod has higher complete clearance rates than vehicle cream for each of the active treatment groups. Additionally, there was not a statistically significant or clinically meaningful difference in complete clearance rate noted between the imiquimod 5×/week (75% composite and 82% histologic) and 7×/week (73% composite and 79% histologic) treatment groups.
Although the studies were blinded, LSRs were most frequently observed with the active
Acknowledgements
Investigators who enrolled subjects in the 1393-IMIQ study: M. Brown, MD, University of Rochester, Rochester, NY; I. Caro, MD, Massachusetts General Hospital, Harvard Medical School, Boston, MA; S. Davis, MD, Dermatology Clinical Research Center of San Antonio, San Antonio, TX; C. Elmets, MD, University of Alabama, Birmingham, AL; P. H. Ely, MD, University of California-Davis, Grass Valley, CA; K. Fang, MD, University of California-Davis, VA Hospital, Martinez, CA; K. Gross, MD, Skin Surgery
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2022, Journal of Plastic, Reconstructive and Aesthetic SurgeryCitation Excerpt :A summary of the outcomes from eligible studies is shown in Table 1. In the two eligible RCTs38,39 comparing topical 5% imiquimod with placebo for clinically diagnosed superficial BCCs, outcomes assessed included histological clearance rates at 6 weeks following the end of treatment and adverse events during treatment. Depending on the frequency of cream administration, histological clearance rates ranged from 51.7-100% for those treated with 5% imiquimod and from 2.0-18.8% for individuals in the placebo (i.e. observational) group.
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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).