Zyclara imiquimod: Phase III data

Pooled data from the intent-to-treat (ITT) population (n=981) of a pair of double-blind Phase III trials showed that 2.5% and 3.75% imiquimod cream applied once daily for up to 8 weeks significantly increased the rate of complete clearance of all warts vs. placebo (22.1% and 28.3%, respectively, vs. 9.4%, p<0.001 for both). In the per-protocol (PP) population (n=716), low- and high-dose imiquimod led to complete clearance of all warts in 27% and 33.8% of patients, respectively, vs. 11.5% for placebo. Furthermore, 2.5% and 3.75% imiquimod led to higher partial clearance rates, defined as a >=75% reduction in wart count, vs. placebo in the PP population (36.3% and 45.9%, respectively, vs. 13.4%). In patients who achieved complete clearance at week 8 and entered a 12-week follow-up period, complete clearance was sustained in 59.5% and 69.6% of patients receiving low- and high-dose imiquimod, respectively, vs. 92.3% for placebo. Data were presented at the Human Papillomavirus meeting in Montreal. ...