A new 3.75% imiquimod cream for treating actinic keratoses has been approved by the Food & Drug Administration, the product’s manufacturer announced today.
In clinical trials, Zyclara (Graceway Pharmaceuticals) reduced the total number of lesions by 82% in patients who averaged 11 lesions at baseline. Complete clearance of all lesions, including those that developed during treatment, was achieved in 36% of patients, compared with only 6% of patients who received the placebo.
The new formulation is designed for once daily application, and according to Graceway, quickly treats a greater number of lesions over a larger area than its 5% imiquimod cream predecessor.
“Because AKs are precancerous and can develop on skin frequently exposed to the sun, such as the face or balding scalp, an effective treatment that can be used on large areas of skin is beneficial,” noted Dr. Darrell Rigel, a clinical professor of dermatology at New York University’s Medical Center. Dr. Rigel is an investor for Graceway Pharmaceuticals.