Genital
human papillomavirus infection is one of the most common
sexually transmitted diseases.
Imiquimod is a new agent, an immune-response modifier, that has been demonstrated to have potent in vivo
antiviral and antitumor effects in animal models. The present prospective, multicenter, double-blind, randomized, vehicle-controlled trial evaluated the efficacy and safety of daily patient-applied
imiquimod for up to 16 weeks for the treatment of external
genital warts.
Wart recurrence was investigated during a 12-week treatment-free follow-up period. In the intent-to-treat analysis, baseline
warts cleared from 49 of 94 (52%) patients treated with 5%
imiquimod cream, 13 of 90 (14%) patients treated with 1%
imiquimod cream, and 3 of 95 (4%) vehicle-treated patients; the differences between the groups treated with vehicle and
imiquimod were significant (P < 0.0001). For subjects who completed the follow-up period, recurrence rates after a complete response were 19% (9 of 48 patients) in the 5%
imiquimod cream group, 17% (2 of 12) in the 1%
imiquimod cream group, and 0% (0 of 3) in the vehicle-treated group. There were no systemic reactions, although local skin reactions (generally of mild or moderate severity) were common, particularly in the 5%
imiquimod cream group. Local reactions caused two patients to discontinue treatment. The most frequently reported local skin reactions were
erythema, excoriation or flaking, and erosion. Patient-applied 5%
imiquimod cream is effective for the treatment of external
genital warts and has a favorable safety profile.