Efficacy and safety of imiquimod versus podophyllotoxin in the treatment of anogenital warts.

Background: Anogenital warts are a common sexually transmitted disease caused by human papillomaviruses. Despite the fact, that imiquimod and podophyllotoxin represent common topical agents, direct comparative studies lack. This work compares the effectiveness and safety of self-applied imiquimod 5% cream and podophyllotoxin 0.5% solution.

Methods: Within 2 years, consecutive patients presenting with untreated anogenital warts were included in a randomized, open label trial. The primary endpoint was complete clearance at the end of treatment (4 weeks after the start with podophyllotoxin, 16 weeks after the start of imiquimod therapy). Side effects were evaluated as a secondary endpoint.

Results: A total of 45 patients, 7 women and 35 men, of whom 5 were circumcised, concluded the treatment and were eligible for evaluation. The rates of clearance of baseline warts among treatment groups were 72% (95% confidence interval [CI], 52%-86%) in the podophyllotoxin group and 75% (95% CI, 53%-98%) in the imiquimod group. Statistically, clearance rates were identical (P=1). The differences in side effects between treatment groups were statistically not significant (P=0.24).

Conclusions: The current study, a direct comparison of both, confirms the previously obtained mathematical data, that imiquimod 5% cream and podophyllotoxin 0.5% solution have an identical beneficial effect on anogenital warts and are associated with identical and acceptable side effects. Both substances constitute effective and safe treatments of untreated anogenital warts in immunocompetent individuals.