Treatment of external genital warts in men using 5% imiquimod cream applied three times a week, once daily, twice daily, or three times a day

Kenneth Fife, Alex Ferenczy, John M. Douglas, Darron Brown, Michael Smith, Mary L. Owens, Karl Beutner, Donald Poretz, Richard Reichman, Malcom Sperling, Spotswood Spruance

Research output: Contribution to journalArticle

62 Citations (Scopus)

Abstract

Background: Medical therapy for genital warts remains suboptimal. The topical interferon and cytokine inducer, imiquimod, has been proved effective for the treatment of external genital and perianal warts, but there is a substantial difference in the response rates between men and women. When 5% imiquimod cream is applied three times a week up to 16 weeks, approximately two thirds of women treated with imiquimod achieve complete clearance of genital warts, whereas only about one third of men clear completely. Goal: This study was undertaken to determine whether more frequent application of topical imiquimod cream would improve the rate of genital wart clearance in men. Study Design: A randomized treatment trial involving adult men with biopsy-proven genital warts was conducted at nine centers in the United States and Canada using four different application frequencies. Results: Complete clearance rates during the 16-week treatment period were as follows for the different imiquimod treatment frequencies: three times a week (35%), once daily (28%), twice daily (24%), and three times a day (27%)(P = 0.88). The four treatment groups all showed comparable reductions in the total lesion area, with a median of more than a 90% reduction in the lesion area by the end of treatment. There was a significant increase in the incidence and severity of local skin reactions including erythema, vesicle formation, ulceration, and excoriation as the dosing frequency increased from three times a week to three times a day. Conclusion: In this study, the optimal dosage regimen was the approved three times a week regimen. More frequent application (up to three times a day) did not improve clearance and was associated with an increase in local adverse events.

Original languageEnglish
Pages (from-to)226-231
Number of pages6
JournalSexually Transmitted Diseases
Volume28
Issue number4
StatePublished - 2001

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imiquimod
Condylomata Acuminata
Therapeutics
Interferon Inducers
Erythema
Canada
Cytokines
Biopsy

ASJC Scopus subject areas

  • Dermatology
  • Public Health, Environmental and Occupational Health
  • Microbiology (medical)

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Treatment of external genital warts in men using 5% imiquimod cream applied three times a week, once daily, twice daily, or three times a day. / Fife, Kenneth; Ferenczy, Alex; Douglas, John M.; Brown, Darron; Smith, Michael; Owens, Mary L.; Beutner, Karl; Poretz, Donald; Reichman, Richard; Sperling, Malcom; Spruance, Spotswood.

In: Sexually Transmitted Diseases, Vol. 28, No. 4, 2001, p. 226-231.

Research output: Contribution to journalArticle

Fife, K, Ferenczy, A, Douglas, JM, Brown, D, Smith, M, Owens, ML, Beutner, K, Poretz, D, Reichman, R, Sperling, M & Spruance, S 2001, 'Treatment of external genital warts in men using 5% imiquimod cream applied three times a week, once daily, twice daily, or three times a day', Sexually Transmitted Diseases, vol. 28, no. 4, pp. 226-231.
Fife, Kenneth ; Ferenczy, Alex ; Douglas, John M. ; Brown, Darron ; Smith, Michael ; Owens, Mary L. ; Beutner, Karl ; Poretz, Donald ; Reichman, Richard ; Sperling, Malcom ; Spruance, Spotswood. / Treatment of external genital warts in men using 5% imiquimod cream applied three times a week, once daily, twice daily, or three times a day. In: Sexually Transmitted Diseases. 2001 ; Vol. 28, No. 4. pp. 226-231.
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AU - Smith, Michael

AU - Owens, Mary L.

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AU - Poretz, Donald

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