Safety and efficacy of imiquimod 5% cream in the treatment of penile genital warts in uncircumcised men when applied three times weekly or once per day

Int J STD AIDS. 2001 Jan;12(1):22-8.

Abstract

This dose-escalation study was performed to evaluate safety and efficacy of imiquimod 5% cream in the treatment of uncircumcised men with penile warts associated with the foreskin. The cream was applied 3 times/week (n=34) or once per day (n=30) over 8+/-2 h. Imiquimod 5% cream was safe in both treatment groups. However, the 3 times/week regimen was better tolerated with a lower incidence of local skin reactions. In both groups, the 2 most frequently reported local skin reactions were erythema and erosion; they were more severe with the once-daily dosing. The most frequently reported application site reactions were burning, pruritus and irritation or pain (once-daily patients only). Total clearance was achieved in 62% of the patients in the 3 times/week group and by 57% in the once-daily group. Thus, imiquimod 5% cream administered 3 times/week was the optimal dosing regimen in the treatment of penile warts in uncircumcised men.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Topical
  • Adolescent
  • Adult
  • Aminoquinolines / adverse effects
  • Aminoquinolines / therapeutic use*
  • Condylomata Acuminata / drug therapy*
  • Erythema / chemically induced
  • France
  • Germany
  • Humans
  • Imiquimod
  • Interferon Inducers / adverse effects
  • Interferon Inducers / therapeutic use*
  • Male
  • Pain / chemically induced
  • Penile Diseases / drug therapy*
  • Pruritus / chemically induced

Substances

  • Aminoquinolines
  • Interferon Inducers
  • Imiquimod