Major Finding: A 3.75% imiquimod cream used daily for 2 weeks yielded a median reduction in AK lesions of 82%.
Data Source: Two randomized trials including 969 patients.
Disclosures: Both studies were funded by Graceway Pharmaceuticals. Dr. Swanson, Dr. Hanke, and their coauthors have financial relationships with 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 the first study, 160 patients were randomized to 3.75% imiquimod cream (Aldara, Graceway Pharmaceuticals), 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, said Dr. Neil Swanson of Oregon Health and Science University, Portland, and his colleagues 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.
“Median percent lesion reduction of 81.8% was comparable to that observed for imiquimod 5% cream applied for 16 weeks,” the researchers noted. Median lesion reduction from baseline was 71.8% in the 2.5% group and 25% in the placebo group.
A companion study randomized 164 patients to a placebo cream, 164 patients to imiquimod 2.5% cream, and 162 patients to imiquimod 3.75% cream. No significant improvement was seen with either imiquimod cream, reported Dr. C. William Hanke, a dermatologic surgeon in Carmel, Ind., and his 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 colleagues wrote.