PMID- 26682290 OWN - NLM STAT- MEDLINE DCOM- 20161007 LR - 20220331 IS - 2326-6929 (Electronic) IS - 0011-4162 (Linking) VI - 96 IP - 4 DP - 2015 Oct TI - Imiquimod cream 2.5% and 3.75% applied once daily to treat external genital warts in men. PG - 277-82 AB - 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. FAU - Rosen, Ted AU - Rosen T AD - Department of Dermatology, Baylor College of Medicine, Houston, Texas, USA. FAU - Nelson, Anita AU - Nelson A AD - Department of Obstetrics and Gynecology, Harbor-UCLA Medical Center, Torrance, California, USA. FAU - Ault, Kevin AU - Ault K AD - Department of Gynecology and Obstetrics, Emory University School of Medicine, Atlanta, Georgia, USA. LA - eng PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - Cutis JT - Cutis JID - 0006440 RN - 0 (Adjuvants, Immunologic) RN - 0 (Aminoquinolines) RN - P1QW714R7M (Imiquimod) SB - IM MH - Adjuvants, Immunologic/*administration & dosage/adverse effects MH - Adult MH - Aminoquinolines/*administration & dosage/adverse effects MH - Condylomata Acuminata/*drug therapy MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Follow-Up Studies MH - Humans MH - Imiquimod MH - Male MH - Treatment Outcome EDAT- 2015/12/19 06:00 MHDA- 2016/10/08 06:00 CRDT- 2015/12/19 06:00 PHST- 2015/12/19 06:00 [entrez] PHST- 2015/12/19 06:00 [pubmed] PHST- 2016/10/08 06:00 [medline] AID - NJ_0C00306E [pii] PST - ppublish SO - Cutis. 2015 Oct;96(4):277-82.