Randomized, comparative trial on the sustained efficacy of topical imiquimod 5% cream versus conventional ablative methods in external anogenital warts.

Conventional ablative treatments for external anogenital warts are affected by high recurrence rates. This study compared sustained clearance after ablation vs. treatment with imiquimod 5% cream vs. the combination of both methods. This was a 3-arm, open-label, randomized clinical study comparing ablation alone (Group A), imiquimod 5% cream monotherapy (Group B), or combined ablation followed by topical imiquimod (Group C). Subjects whose anogenital warts were completely cleared entered a 6-month follow-up to evaluate sustained clearance. After 3 months follow-up, 83.9% (73/87), 93.8% (90/96) and 91.7% (66/72) of subjects in Groups A, B, C, respectively, remained free of recurrent anogenital warts. After 6-months follow-up, 73.6% (64/87), 93.7% (89/95) and 91.5% (65/71) of subjects presented free of recurrence (Group A vs. B & C p-values each p < 0.004 in favour of the imiquimod-treated groups). Imiquimod 5% cream, as monotherapy or in combination with ablation, was superior to ablation alone in reducing the recurrence of successfully treated anogenital warts.