TREATMENT OF GENITAL HERPES IN MALES WITH IMIQUIMOD 1-PERCENT CREAM -A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Objective: The aim of this randomised, double-blind, placebo-controlle d study was to examine the clinical significance, efficacy and tolerab ility of imiquimod 1% cream to manage patients exposed to first episod es of genital herpes. Patients: Male patients (n = 60), ranging in age between 18 and 50 years (mean 25.7 years), presenting for <6 days (me an 4.4 days) with culture-confirmed diagnosis of genital herpes, and b earing a total of 696 lesions (mean 11.6 lesions/patient), entered the study and were randomised to receive a preceded 40g tube and instruct ions on how to apply the trial medication to their lesions twice for 5 consecutive days per week. Results: A marked clinical benefit from se lf-application of imiquimod 1% cream was demonstrated, resulting in bo th significantly shorter mean duration of healing than with the placeb o (5.2 vs 14 days; p < 0.001) and more healed patients [23 of 30 (76.7 %) vs 2 of 30 (6.7%); p < 0.0001]. Of the 60 patients, 54 (90%) report ed no drug-related adverse effects. Two patients in the imiquimod grou p reported non-objective mild burning sensation and four experienced a transitory increase in their body temperature (>38 degrees C) accompa nied by mild headache and malaise; however, such indications were not severe enough to cause discontinuation of the treatment, and resolved within 24 hours. Treatment was well tolerated by all the patients, wit h no dropouts. Among 25 healed patients, four had a relapse after 9 mo nths. Conclusion: Although the analogue of imiquimod 1% cream demonstr ated mild to moderate subjective adverse effects, it was significantly more effective than placebo in treating patients with a first episode of genital herpes. Further clinical studies appear warranted.