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Health Canada Approves Imiquimod Cream for Actinic Keratosis NEW YORK -- January 5, 2010 -- Health Canada has approved imiquimod cream 3.75% (Zyclara) for the treatment of multiple actinic keratosis (AK) of the face or balding scalp in adults with normal immune systems. The approval was based on phase 3 studies which enrolled 319 adults with 5 to 20 AK lesions in a large treatment area (full face or balding scalp). Patients applied up to 500 mg of cream daily for two, 2-week cycles, separated by a no-treatment interval of 2 weeks. The primary endpoint was complete clearance, defined as the number of patients with zero AKs at the end of the study. The secondary endpoints were partial clearance rates and the percent change in AK number at the end of the study versus baseline. Efficacy was assessed 8 weeks after the last dose. Imiquimod was shows to be statistically superior to placebo. Patients treated with imiquimod had 36% complete clearance of AK versus 6% for placebo. In addition, imiquimod reduced the total number of AKs by 82%. The majority of subjects in the imiquimod group had increases in the number of lesions from baseline during treatment, consistent with the unmasking of subclinical AK lesions. Clearance rates reflect treatment of both visible or palpable and new lesions. Local skin reactions, such as redness, are consistent with treatment response. The most commonly reported severe local skin reactions with imiquimod during the 2-week treatment cycle regimen were redness (25%), scabbing/crusting (14%), skin peeling (11%), and flaking, scaling or dryness (8%). SOURCE: Graceway Pharmaceuticals, LLC E-mail this page to a friend or colleague! To print, use this version