Imiquimid 5% cream dosed 3 times weekly for the treatment of actinic keratosis

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Imiquimod 5% cream is an immune response modifier that works by enhancing the innate and adaptive immune responses. Since imiquimod can induce strong immune responses that vary depending on intrinsic and extrinsic factors, infrequent dosing for an extended duration was evaluated. Two large, randomized, vehicle controlled studies were conducted to determine if imiquimod 5% cream dosed 3 times weekly for 16 weeks was a safe and effective treatment for actinic keratosis. Overall, 492 patients from 26 clinical sites applied study cream to a contiguous 25-cm2-treatment area containing 4 to 8 AK lesions on the face or balding scalp (not both). Patients were randomized in a 1 to 1 ratio. The combined data indicated that imiquimod was statistically significantly better than vehicle with respect to both complete clearance rate (48.3% vs 7.2%, p < 0.0001), defined as the proportion of patients at the 8-week posttreatment visit with no clinically visible AK lesions in the treatment area, and partial clearance rate (64.0% vs. 13.6%, p < 0.0001), defined as the proportion of patients at the 8-week posttreatment visit with at least a 75% reduction in the number of AK lesions counted at baseline in the treatment area. A complete clearance rate of 57% for another large, randomized, vehicle-controlled study with histology suggests the complete clearance rate for 3-times weekly dosing may be closer to 60%. The combined safety profile was acceptable. The results indicate that 3 times per week dosing with imiquimod 5% cream is a safe and effective treatment for actinic keratosis. Imiquimod 5% cream is an immune response modifier that works by enhancing the innate and adaptive immune responses. Since imiquimod can induce strong immune responses that vary depending on intrinsic and extrinsic factors, infrequent dosing for an extended duration was evaluated. Two large, randomized, vehicle controlled studies were conducted to determine if imiquimod 5% cream dosed 3 times weekly for 16 weeks was a safe and effective treatment for actinic keratosis. Overall, 492 patients from 26 clinical sites applied study cream to a contiguous 25-cm2-treatment area containing 4 to 8 AK lesions on the face or balding scalp (not both). Patients were randomized in a 1 to 1 ratio. The combined data indicated that imiquimod was statistically significantly better than vehicle with respect to both complete clearance rate (48.3% vs 7.2%, p < 0.0001), defined as the proportion of patients at the 8-week posttreatment visit with no clinically visible AK lesions in the treatment area, and partial clearance rate (64.0% vs. 13.6%, p < 0.0001), defined as the proportion of patients at the 8-week posttreatment visit with at least a 75% reduction in the number of AK lesions counted at baseline in the treatment area. A complete clearance rate of 57% for another large, randomized, vehicle-controlled study with histology suggests the complete clearance rate for 3-times weekly dosing may be closer to 60%. The combined safety profile was acceptable. The results indicate that 3 times per week dosing with imiquimod 5% cream is a safe and effective treatment for actinic keratosis.