ReportImiquimod 5% cream for the treatment of actinic keratosis: results from two phase III, randomized, double-blind, parallel group, vehicle-controlled trials☆
Section snippets
Study population
Eligible participants were otherwise healthy men and women at least 18 years of age with 4 to 8 clinically diagnosed AK lesions located within a contiguous 25-cm2 treatment area on the face or balding scalp, but not both. Participants were to be excluded from the study if they had any condition in the treatment area that could be exacerbated by treatment with imiquimod 5% cream or that would impair the examination of the treatment area. If a participant had previously received treatment with
Study population
Between the two studies, a total of 623 people were screened and 436 (217 in one study and 219 in the other) were enrolled. Violations of inclusion or exclusion criteria were the most common reasons for study ineligibility. Overall, 215 participants were randomized to treatment with imiquimod 5% cream, and 221 were randomized to treatment with vehicle cream. Participant accountability is shown in Fig 1. There were no significant differences between treatment groups for age, sex, race, or
Discussion
Imiquimod 5% cream is an effective and well-tolerated treatment option for AK lesions on the face and scalp. The results confirm earlier study results and published anecdotes that showed imiquimod 5% cream was an effective treatment for AK. The benefits of treatment with topical imiquimod 5% cream include complete clearance of AK lesions for 45.1% of participants and partial clearance (≥75% reduction in the number of baseline lesions) for 59.1% of participants.
According to this protocol,
Acknowledgements
We thank Nanda Gosala, MD, for medical monitoring; Mary Owens, MD, for editorial contributions; Scott McKane for statistical analyses support; and Áine Skow for manuscript preparation.
The following are principal investigators who participated in the study: Scott Dinehart, MD (coordinating investigator); Mark Lebwohl, MD (coordinating investigator); Donald Belsito, MD; Robert Brown, MD; Charles Dugan, MD; Richard Fitzpatrick, MD; Scott Fosko, MD; Glenn Goldman, MD; William Harwell, MD; Joseph
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2021, Journal of the American Academy of DermatologyCitation Excerpt :Studied in concentrations of 5%, 3.75%, and 2.5%, most data on the efficacy of topical imiquimod for the management of AKs were derived from 8 RCTs studying 5% imiquimod cream applied 2 to 3 times a week for 1 to 2 treatment courses. These 8 trials reported complete clearance rates of between 3.2% and 55% (average 29.3%) for 9 to 24 doses and between 3.3% and 84% (average 40.8%) for 32 to 56 doses (Supplemental e-Table 2a).58-60,63,65-67,69 These studies report adverse effects of treatment, including local skin reactions in up to 98% of patients, influenza-like symptoms in 3.2% to 10.3% of patients, and infection in 1.6% to 2.3% of patients (Supplemental e-Tables 2b and 2c).
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Supported by 3M Pharmaceuticals, St Paul, Minnesota.
Disclosure: Drs Lebwohl, Dinehart, Whiting, P. Lee, Tawfik, and Jorizzo have received support from 3M Pharmaceuticals for performing clinical trials. Drs Jorizzo and P. Lee have served as consultants for 3M Pharmaceuticals. Drs Lebwohl and Tawfik have received speaking honoraria. Dr J. Lee and Mr Fox are employees of 3M Pharmaceuticals.
Portions of this information have been presented at the 62nd Annual Meeting of the American Academy of Dermatology, Washington, DC, February 6-11, 2004 and at ACADEMY 2003, Chicago, Ill, July 25-29, 2003.