ReportImiquimod 5% cream for the treatment of actinic keratosis: Results from a phase III, randomized, double-blind, vehicle-controlled, clinical trial with histology☆
Section snippets
Study population
Eligible patients were otherwise healthy men and women at least 18 years of age with 5 to 9 clinically diagnosed and histologically confirmed AK lesions located within a contiguous 25-cm2 treatment area on the face or balding scalp. The treatment area could not include both the face and balding scalp. Patients 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
Study population
A total of 327 people were screened and 286 were enrolled. Violations of inclusion or exclusion criteria were the most common reasons for study ineligibility. Overall, 147 patients were randomized to treatment with imiquimod 5% cream and 139 patients were randomized to treatment with vehicle cream. Patient accountability is shown in Fig 1. There were no significant differences between treatment groups for age, sex, race, or Fitzpatrick skin type (Table II).
Efficacy
Imiquimod 5% cream was statistically
Discussion
The results from this study demonstrate that imiquimod 5% cream dosed once daily 3 times weekly for 16 weeks is an effective and well-tolerated treatment option for AK lesions on the face and scalp. These results confirm the results of previous studies that showed imiquimod 5% cream was an effective treatment for AK when dosed once daily 2 times weekly for 16 weeks. The benefits of treatment with topical imiquimod 5% cream included complete clearance or partial clearance (≥75% reduction in the
Acknowledgements
We would like to thank Scott W. McKane for statistical analysis and Amy L. Brown for manuscript preparation.
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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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2020, Advanced Drug Delivery ReviewsCitation Excerpt :In an early Phase II study, it was found that patients (22 individuals) treated with a 5% IMQ cream (3 times per week over 8 weeks) had a significant reduction in AK count and dimension compared to vehicle treated individuals [53]. A subsequent multicenter Phase III trial (286 patients, 5% IMQ cream administered to an area no bigger than 25 cm2, 3 times per week for 16 weeks) showed a complete clearance rate of 57.1% in patients treated with 5% IMQ vs. 2.2% of vehicle treated individuals after 24 weeks [54]. Further trials with a similar treatment regime have shown comparable efficacy [55].
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Supported by 3M Pharmaceuticals, St Paul, Minn.
Disclosure: Drs Szeimies, Gerritsen, Gupta, Ortonne, Serresi, and Alomar have received support from 3M Pharmaceuticals for performing clinical trials. Drs Gupta, Alomar, Ortonne, and Gerritsen have served as consultants and/or received honoraria from 3M Pharmaceuticals. Dr Szeimies is also a consultant for other companies that have and are developing treatments for actinic keratosis. Dr Bichel, Dr Lee, and Mr Fox are employees of 3M Pharmaceuticals.
Results have been presented in part at the 12th Congress of the European Academy of Dermatology and Venerology, Barcelona, Spain, October 15-18, 2003. Several abstracts and posters that contain the results presented in this manuscript were presented at the 62nd Annual Meeting of the American Academy of Dermatology, Washington, DC, February 6-11, 2004.