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Libby Edwards, MD; Alex Ferenczy, MD; Lawrence Eron, MD; David Baker, MD; Mary L. Owens, MD; Terry L. Fox, MS; Andrina J. Hougham; Kathy A. Schmitt; and the HPV Study Group

Arch Dermatol. 1998;134:25-30.

Objective  To compare the safety and effectiveness of 5% and 1% imiquimod cream with vehicle cream in the treatment of external anogenital warts.

Design  Randomized, double-blind, placebo-controlled comparison that evaluated patients for total clearance of their warts. Patients who experienced total clearance were evaluated for recurrence in a 12-week follow-up.

Setting  Eleven ambulatory offices, including both private physician offices and referral medical centers.

Patients  Three hundred eleven healthy men and women aged 18 years or older with 2 to 50 external anogenital warts were recruited from the practices of investigators, referring physicians, and advertisements. Eighty-two additional patients were screened but did not qualify. Four patients discontinued use of the medication because of adverse effects.

Interventions  Five percent imiquimod (Aldara) cream, 1% imiquimod cream, or vehicle cream was applied to all external warts overnight 3 times each week for 16 weeks, or until all treated warts disappeared, whichever occurred first.

Main Outcome Measurements  The number of patients experiencing the elimination of all baseline warts and the recurrence rate of these warts. In addition, the reduction in baseline wart area, the duration of therapy required to eliminate warts, and the frequency and severity of adverse reactions were principal measurements.

Results  In the intent-to-treat analysis, 54 (50%) of 109 patients who received 5% imiquimod cream, 21 (21%) of 102 of those who received 1% imiquimod cream, and 11 (11%) of 100 patients treated with vehicle cream experienced eradication of all treated baseline warts. The difference between the effectiveness of 5% imiquimod cream and the vehicle cream was statistically significant (P<.001). Of those patients whose warts cleared during therapy, 13% of patients who received 5% imiquimod experienced a recurrence of at least 1 wart. Recurrences occurred in none of the patients who used 1% imiquimod cream and in 10% of patients who used the vehicle cream. Local erythema was the most common adverse reaction, but the majority of patients in each group experienced no or only mild local inflammatory reactions. There were no differences in incidences of flulike symptoms among treatment groups.

Conclusions  Five percent imiquimod cream is an effective and safe self-administered therapy for external anogenital warts when applied 3 times a week overnight for up to 16 weeks. The recurrence rate is low.

From the Department of Internal Medicine, Carolinas Medical Center, Charlotte, NC (Dr Edwards); the Department of Pathology, Jewish General Hospital, Montreal, Quebec (Dr Ferenczy); Kauai Medical Group, Lihue, Hawaii (Dr Eron); the Department of Obstetrics and Gynecology, State University of New York at Stony Brook (Dr Baker); and 3M Pharmaceuticals, St Paul, Minn (Dr Owens and Mss Fox, Hougham, and Schmitt).

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