Medication Monitor

Generic Name (Trade Name—Company)
April 1, 2011


Treatment of external genital and perianal warts


Treatment of external genital and perianal warts in patients 12 years of age and older

Approval of Zyclara was based on data from two Phase III, double-blind studies that evaluated the complete clearance of warts across several anatomical locations with imiquimod 3.75% cream. Approximately 28.3% of patients using once-daily imiquimod cream for up to 8 weeks had complete clearance of all warts compared with 9.4% of those given placebo cream. In addition, only 15% of patients treated with imiquimod experienced a recurrence within 12 weeks. The product was originally approved for the treatment of actinic keratoses of the face or balding scalp in immunocompetent patients.