Imiquimod Cream 2.5% and 3.75% Applied Once Daily to Treat External Genital Warts in Men
We assess the safety and efficacy of imiquimod cream 3.75% and 2.5% in men with external genital warts (EGWs). Two multicenter, randomized, double-blind, placebo-controlled studies were conducted in a total of 447 (225 from study 1 and 222 from study 2) male patients (aged ≥12 years) with 2 to 30 EGWs and a total wart area of 150 mm2 or greater. Participants were randomized (2:2:1) to imiquimod cream 3.75% or 2.5% or placebo applied once daily until complete clearance or a maximum of 8 weeks (end of treatment [EOT]). There was an 8-week follow-up period (end of study [EOS]) for participants who did not achieve complete clearance by EOT. Participants who achieved complete clearance were observed for an additional 12 weeks. The primary efficacy end point was complete clearance rate. Safety assessments included visual assessment of local skin reactions, number and duration of required rest periods, adverse events (AEs), and clinical laboratory tests. Study results indicated that new imiquimod formulations are beneficial in treating EGWs in men.
Practice Points
- Imiquimod cream, both 2.5% and 3.75% concentrations, is more effective than placebo in treating external genital warts (EGWs) in men.
- Imiquimod cream, in both concentrations tested, is somewhat less effective in men than in women in the same protocol.
- Imiquimod cream treatment of EGWs is better tolerated in men than in women in the same protocol.
Acknowledgments—The authors thank Christina Cognata Smith, PharmD, and Mandeep Kaur, MD (both previously of Valeant Pharmaceuticals North America, LLC, Bridgewater, New Jersey), as well as Brian Bulley, MSc (Inergy Limited, Lindfield, West Sussex, United Kingdom), for assistance with the preparation of the manuscript. Valeant Pharmaceuticals North America, LLC, funded Inergy’s activities pertaining to this analysis.
