Zyclara imiquimod: Phase IIIb data

In a U.S. and Canadian Phase IIIb trial in 260 patients, Zyclara following cryosurgery met the primary endpoint of significantly reducing the median number of total AK lesions from baseline to week 26 vs. placebo (86.5% vs. 50%, p<0.0001). Zycara also significantly reduced both cryosurgery- and non-cryosurgery-treated AK lesions vs. placebo (100% vs. 80% and 83.3% vs. 22.2%, respectively; p=0.0008 and p<0.0001).

On secondary endpoints, Zycara significantly improved complete clearance of total AK lesions (30.2% vs. 3.3%, p<0.0001), cryosurgery-treated lesions (59.5% vs. 29.8%, p<0.0001), and non-cryosurgery-treated lesions vs. placebo (34.1% vs. 5%, p<0.0001). Zycara also significantly improved photodamage assessments of the face vs. placebo, including global photoaging (51.6% vs. 19.3%), fine lines (32.8% vs. 15.1%), mottled pigmentation (46.7% vs. 18.5%) and tactile roughness (61.5% vs. 22.7%). Additionally, Zyclara led to higher rates of patient satisfaction (70.2% vs. 31.1%) and investigator satisfaction (72.1% vs. 16.8%) vs. placebo. Data were presented at the American Academy of Dermatology meeting in Chicago. ...