Korman N, Moy R, Ling M, Matheson R, Smith S, McKane S et al.. Dosing with 5% imiquimod cream 3 times per week for the treatment of actinic keratosis: results of two phase 3, randomized, double-blind, parallel-group, vehicle-controlled trials. Arch Dermatol 141: 467-473

Department of Dermatology, University Hospitals of Cleveland, Case Western Reserve University, Cleveland, Ohio, USA.
Archives of Dermatology (Impact Factor: 4.79). 04/2005; 141(4):467-73. DOI: 10.1001/archderm.141.4.467
Source: PubMed


To evaluate the efficacy and safety of 5% imiquimod cream compared with vehicle in the treatment of actinic keratosis (AK).
Two phase 3 randomized, double-blind, parallel-group, vehicle-controlled studies.
Twenty-six ambulatory care offices, including dermatologists in private practice or research centers.
Four hundred ninety-two patients, 18 years and older, with 4 to 8 AK lesions in a 25-cm(2) treatment area on the face or the balding scalp were randomized; an additional 162 patients underwent screening but were ineligible.
Patients applied 5% imiquimod (Aldara) or vehicle cream to the treatment area once daily, 3 times per week, for 16 weeks, followed by an 8-week posttreatment period.
Complete clearance rate (proportion of patients at the 8-week posttreatment visit with no clinically visible AK lesions in the treatment area), partial clearance rate (proportion of patients at the 8-week posttreatment visit with a >/=75% reduction in the number of baseline AK lesions in the treatment area), and frequency and severity of adverse events and local skin reactions were measured.
Complete and partial clearance rates for imiquimod-treated patients (48.3% and 64.0%, respectively) were clinically and statistically significantly higher than for vehicle-treated patients (7.2% and 13.6%, respectively). The median percentage reduction of baseline lesions was 86.6% for the imiquimod-treated group and 14.3% for the vehicle-treated group.
The 5% imiquimod cream dosed 3 times weekly for 16 weeks is safe and effective for the treatment of AK.


Available from: Mark Russell Ling, Aug 07, 2014
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    • "The lowest concentration is FDA (Food and Drug Administration) approved and has several advantages such as the possibility of application in broader areas and even shorter schemes with 2 applications a day for 6 weeks.14 Several well-conducted randomized controlled clinical trials on Imiquimod, using placebo and other controls, demonstrated rates of cure of 45% to 84% and recurrence rates of 10% in 12 months and 20% in 24 months.28-30 Treatment schemes vary from applications 2 to 3 times a week up to daily use for 16 weeks. "
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    • "TLR7 is the therapeutic target of imiquimod, which has been used successfully in the treatment of skin cancers.44–46 Given that TLR9 is expressed predominantly in B cells, it is currently being explored in clinical trials for cutaneous lymphoma47 and leukemia.48 "
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    • "Imiquimod (5%) cream is an immune response modi�er that acts via stimulation of a Toll-like receptor culminating in malignant cell apoptosis and a local 1-based immune response. Randomised controlled trials have demonstrated its efficacy both clinically and histologically over a 16-week treatment course [33] [34]. Complete clinical clearance was achieved in 47% of patients and partial in 64%. "
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