[Efficacy and safety of 5% imiquimod cream in external genital warts: a 6 month follow-up evaluation].

INTRODUCTION

One of the main issues raised by the management of external genital warts is their potential risk of recurrence. However, nearly all studies assessing recurrences have been conducted with a 3 month follow-up. Since the latency of the human papillomavirus is long, such 3 month follow-up might be too short to detect the true recurrence rate. We therefore conducted a study evaluating patients with external genital warts, treated with an immune response modifier, 5% imiquimod cream, and followed up to 6 months after total clearance.

METHODS

This was an open, non comparative, multicenter study conducted in 51 private or hospital practices in France. 5% imiquimod cream was applied 3 times per week until the clearance of external genital warts, with a maximum application period of 16 weeks. Patients were followed-up for 6 months after complete clearance.

RESULTS

One hundred ninety-one patients (103 males and 88 females), with a mean age of 31.4 years (18.1-70.4) were included in this study, between November 29 1999 and February 1st 2001. Complete clearance of external genital warts was noted in the ITT analysis in 103/191 cases (54 p. 100; CI95 p. 100: 40-61). Fifteen out of 92 (16 p. 100; CI95 p. 100: 9.4-25.5) had a recurrence within the 6 months follow-up period, 13 of these 15 recurrences were noted at the 3 month follow-up visit.

CONCLUSION

The rate of recurrence of external genital warts at 6 months was similar to the rate noted at 3 months, suggesting that after the 3-month period, the risk of developing a recurrence was low. The mode of action of imiquimod through the induction of cytokines and the stimulation of the local immune response could explain these results.