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Antimicrobial Agents and Chemotherapy, April 1998, p. 789-794, Vol. 42, No. 4
0066-4804/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.

Imiquimod, a Patient-Applied Immune-Response Modifier for Treatment of External Genital Warts

Karl R. Beutner,1,2,* Stephen K. Tyring,3 Kenneth F. Trofatter Jr.,4 John M. Douglas Jr.,5 Spotswood Spruance,6 Mary L. Owens,7 Terry L. Fox,7 Andrina J. Hougham,7 and Kathy A. Schmitt7

Department of Dermatology, University of California, San Francisco, California 941431; Department of Medicine, Sutter-Solano Medical Center, Vallejo, California 945892; Departments of Dermatology and Microbiology/ Immunology, University of Texas Medical Branch, Galveston, Texas 770583; Department of Obstetrics and Gynecology, Mt. Sinai Medical Center, Cleveland, Ohio 441064; Disease Control Service, Denver Department of Public Health, Denver, Colorado 802045; Division of Infectious Diseases, University of Utah, Salt Lake City, Utah 841326; and 3M Pharmaceuticals, St. Paul, Minnesota 551447

Received 7 July 1997/Returned for modification 2 December 1997/Accepted 10 January 1998

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.

* Corresponding author. Mailing address: 127 Hospital Drive, Suite 204, Vallejo, CA 94589. Phone: (707) 643-5785. Fax: (707) 643-5876. E-mail: kbeutner{at}solderm.com.

Antimicrobial Agents and Chemotherapy, April 1998, p. 789-794, Vol. 42, No. 4
0066-4804/98/$04.00+0
Copyright © 1998, American Society for Microbiology. All rights reserved.


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