Short Course of Imiquimod 3.75% Improves Actinic Keratoses on Face

ORLANDO — Daily application of 3.75% imiquimod cream with a 2-week dosing cycle was well tolerated and effective for treating actinic keratoses in adults, based on data from two studies.

In current treatment regimens, some patients use a 5% concentration imiquimod (Aldara, Graceway) cream twice a week over a treatment period as long as 16 weeks, but a lower dose may allow a shorter treatment period, said Dr. Neil Swanson of Oregon Health and Science University, Portland.

Dr. Swanson and his colleagues randomized 160 patients to 3.75% imiquimod cream, 160 patients to 2.5% imiquimod cream, and 159 patients to a placebo cream. The patients, aged 18 years and older, had 5-20 clinically diagnosed actinic keratoses (AKs) on the face or balding scalp. The study results were presented in a poster at the Orlando Dermatology Aesthetic and Clinical Conference.

Both the 3.75% and 2.5% creams were significantly more effective than placebo at fully clearing AKs after 2 weeks of daily use. Overall, 36% of the 3.75% group and 31% of the 2.5% group achieved complete clearance, vs. 6% of the placebo group.

The 3.75% cream, however, was significantly better than the 2.5% cream for partial clearance and lesion reduction. Approximately 60% of the 3.75% group achieved partial clearance (defined as at least 75%), compared with 48% of the 2.5% group and 23% of the placebo group.

Both concentrations of imiquimod were well tolerated, and most local skin reactions were mild to moderate. Local skin reactions occurred in 1% of the placebo group, 21% of the 2.5% group, and 34% of the 3.75% group. The most common local skin reactions in both groups were erythema, scabbing or crusting, and erosion or ulceration.

"Median percent lesion reduction of 81.8% was comparable to that observed for imiquimod 5% cream applied for 16 weeks in treating a smaller area of fewer lesions," the researchers noted. By comparison, the median lesion reduction from baseline was 71.8% in the 2.5% group and 25% in the placebo group. The average lesion count at baseline was 11 in all three groups.

Patients applied the treatment cream or placebo daily to the treatment areas for approximately 8 hours or overnight and then removed it. The study included two 2-week cycles separated by a 2-week no-treatment period.

In a companion study also presented as a poster at the meeting, there was no significant improvement in effectiveness with either imiquimod 2.5% or 3.75% cream for treating AKs when used daily for two 3-week cycles separated by a 3-week no-treatment period. The study randomized 164 patients to a placebo cream, 164 patients to imiquimod 2.5% cream, and 162 patients to imiquimod 3.75% cream.

Both imiquimod creams were adequately tolerated and significantly more effective than placebo, reported Dr. C. William Hanke, a dermatologic surgeon in Carmel, Ind., and colleagues.

When both studies were evaluated together, though, "efficacy was better with imiquimod 3.75% than with 2.5%. Extending the cycle duration from 2 weeks to 3 weeks did not further increase efficacy," Dr. Hanke and his associates wrote.

Both studies were funded by Graceway Pharmaceuticals. Both Dr. Swanson and Dr. Hanke have served as investigators and consultants for Graceway. Coauthors on both studies include other investigators, consultants, and employees of Graceway.

ORLANDO — Daily application of 3.75% imiquimod cream with a 2-week dosing cycle was well tolerated and effective for treating actinic keratoses in adults, based on data from two studies.

In current treatment regimens, some patients use a 5% concentration imiquimod (Aldara, Graceway) cream twice a week over a treatment period as long as 16 weeks, but a lower dose may allow a shorter treatment period, said Dr. Neil Swanson of Oregon Health and Science University, Portland.

Dr. Swanson and his colleagues randomized 160 patients to 3.75% imiquimod cream, 160 patients to 2.5% imiquimod cream, and 159 patients to a placebo cream. The patients, aged 18 years and older, had 5-20 clinically diagnosed actinic keratoses (AKs) on the face or balding scalp. The study results were presented in a poster at the Orlando Dermatology Aesthetic and Clinical Conference.

Both the 3.75% and 2.5% creams were significantly more effective than placebo at fully clearing AKs after 2 weeks of daily use. Overall, 36% of the 3.75% group and 31% of the 2.5% group achieved complete clearance, vs. 6% of the placebo group.

The 3.75% cream, however, was significantly better than the 2.5% cream for partial clearance and lesion reduction. Approximately 60% of the 3.75% group achieved partial clearance (defined as at least 75%), compared with 48% of the 2.5% group and 23% of the placebo group.

Both concentrations of imiquimod were well tolerated, and most local skin reactions were mild to moderate. Local skin reactions occurred in 1% of the placebo group, 21% of the 2.5% group, and 34% of the 3.75% group. The most common local skin reactions in both groups were erythema, scabbing or crusting, and erosion or ulceration.

"Median percent lesion reduction of 81.8% was comparable to that observed for imiquimod 5% cream applied for 16 weeks in treating a smaller area of fewer lesions," the researchers noted. By comparison, the median lesion reduction from baseline was 71.8% in the 2.5% group and 25% in the placebo group. The average lesion count at baseline was 11 in all three groups.

Patients applied the treatment cream or placebo daily to the treatment areas for approximately 8 hours or overnight and then removed it. The study included two 2-week cycles separated by a 2-week no-treatment period.

In a companion study also presented as a poster at the meeting, there was no significant improvement in effectiveness with either imiquimod 2.5% or 3.75% cream for treating AKs when used daily for two 3-week cycles separated by a 3-week no-treatment period. The study randomized 164 patients to a placebo cream, 164 patients to imiquimod 2.5% cream, and 162 patients to imiquimod 3.75% cream.

Both imiquimod creams were adequately tolerated and significantly more effective than placebo, reported Dr. C. William Hanke, a dermatologic surgeon in Carmel, Ind., and colleagues.

When both studies were evaluated together, though, "efficacy was better with imiquimod 3.75% than with 2.5%. Extending the cycle duration from 2 weeks to 3 weeks did not further increase efficacy," Dr. Hanke and his associates wrote.

Both studies were funded by Graceway Pharmaceuticals. Both Dr. Swanson and Dr. Hanke have served as investigators and consultants for Graceway. Coauthors on both studies include other investigators, consultants, and employees of Graceway.

ORLANDO — Daily application of 3.75% imiquimod cream with a 2-week dosing cycle was well tolerated and effective for treating actinic keratoses in adults, based on data from two studies.

In current treatment regimens, some patients use a 5% concentration imiquimod (Aldara, Graceway) cream twice a week over a treatment period as long as 16 weeks, but a lower dose may allow a shorter treatment period, said Dr. Neil Swanson of Oregon Health and Science University, Portland.

Dr. Swanson and his colleagues randomized 160 patients to 3.75% imiquimod cream, 160 patients to 2.5% imiquimod cream, and 159 patients to a placebo cream. The patients, aged 18 years and older, had 5-20 clinically diagnosed actinic keratoses (AKs) on the face or balding scalp. The study results were presented in a poster at the Orlando Dermatology Aesthetic and Clinical Conference.

Both the 3.75% and 2.5% creams were significantly more effective than placebo at fully clearing AKs after 2 weeks of daily use. Overall, 36% of the 3.75% group and 31% of the 2.5% group achieved complete clearance, vs. 6% of the placebo group.

The 3.75% cream, however, was significantly better than the 2.5% cream for partial clearance and lesion reduction. Approximately 60% of the 3.75% group achieved partial clearance (defined as at least 75%), compared with 48% of the 2.5% group and 23% of the placebo group.

Both concentrations of imiquimod were well tolerated, and most local skin reactions were mild to moderate. Local skin reactions occurred in 1% of the placebo group, 21% of the 2.5% group, and 34% of the 3.75% group. The most common local skin reactions in both groups were erythema, scabbing or crusting, and erosion or ulceration.

"Median percent lesion reduction of 81.8% was comparable to that observed for imiquimod 5% cream applied for 16 weeks in treating a smaller area of fewer lesions," the researchers noted. By comparison, the median lesion reduction from baseline was 71.8% in the 2.5% group and 25% in the placebo group. The average lesion count at baseline was 11 in all three groups.

Patients applied the treatment cream or placebo daily to the treatment areas for approximately 8 hours or overnight and then removed it. The study included two 2-week cycles separated by a 2-week no-treatment period.

In a companion study also presented as a poster at the meeting, there was no significant improvement in effectiveness with either imiquimod 2.5% or 3.75% cream for treating AKs when used daily for two 3-week cycles separated by a 3-week no-treatment period. The study randomized 164 patients to a placebo cream, 164 patients to imiquimod 2.5% cream, and 162 patients to imiquimod 3.75% cream.

Both imiquimod creams were adequately tolerated and significantly more effective than placebo, reported Dr. C. William Hanke, a dermatologic surgeon in Carmel, Ind., and colleagues.

When both studies were evaluated together, though, "efficacy was better with imiquimod 3.75% than with 2.5%. Extending the cycle duration from 2 weeks to 3 weeks did not further increase efficacy," Dr. Hanke and his associates wrote.

Both studies were funded by Graceway Pharmaceuticals. Both Dr. Swanson and Dr. Hanke have served as investigators and consultants for Graceway. Coauthors on both studies include other investigators, consultants, and employees of Graceway.