Treatment of external genital warts in men with imiquimod 2% in cream. A placebo-controlled, double-blind study

Objective: The purpose of this double-blind, placebo-controlled study was t o evaluate the safety clinical efficacy and tolerability of imiquimod (2%) in cream to cure external genital warts in males. Methods: Preselected male patients (n = 60) ranging between 18 and 50 years of age (mean 24.2) harbouring 558 lesions (mean 9.3) with clinical, histop athological and polymerase chain reaction (PCR) confirmed diagnosis of huma n papilloma virus (HPV) infection were randomized to two parallel groups. E ach patient was allocated a preceded 25 g tube, and instructions on how to apply the trial medication to their lesions at home once daily for three co nsecutive days per week (max, 12 application in 4 weeks), To evaluate the s afety clinical efficacy and tolerance, patients were examined on a weekly b asis. Cure was defined as the total elimination of treated warts with PCR, and Southern blot hybridization confirmed negative HPV DNA, Results: By the end of the treatment, 40% (24/60) patients and 49.8% (278/5 58) warts were cured. Breaking the code revealed that imiquimod cream had c ured 70% (21/30) patients and 86.8% of warts, while placebo healed three su bjects and 25 warts (P<0.0001), Eleven patients (18.3%), predominantly in t he imiquimod cream group, experienced mild to moderate, non-objective, drug -related side effects with no dropouts. The study was followed up for 18 mo nths from the first day of the treatment, and among the 26 cured patients, one in the imiquimod cream group and two in the placebo had a relapse after 14 months. Conclusion: The study demonstrated that 2% imiquimod in cream with mild non -objective side effects is safe, tolerable and significantly more effective than placebo in curing external genital warts in males. (C) 2000 The Briti sh Infection Society.