HPV infection is a major risk factor for cervix cancer. Imiquimod is a topical medication that enhances the immune response to HPV-induced genital warts. This study evaluated cervical application of imiquimod as an adjunct to standard treatment for cervical dysplasia.
Fifty-six patients were randomized to standard excisional/ablative treatment versus applications of imiquimod followed by standard treatment. The primary endpoint was dysplasia recurrence within two years.
There were no differences in dysplasia recurrence between the two groups. Treatment was well tolerated, with side effects being mild, but significantly worse in women receiving imiquimod for, chills, fatigue, fever, headache, myalgias and vaginal discharge.
This trial does not support the hypothesis that imiquimod, as used in this trial, impacts recurrence of cervical dysplasia, but adequacy of findings are limited by sample size. The trial does support the feasibility and acceptability of the use of imiquimod on the cervix.