Abstract：
: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.
journal_name
Cutisjournal_title
Cutisauthors
Rosen T,Nelson A,Ault Ksubject
Has Abstractpub_date
2015-10-01 00:00:00pages
277-82issue
4eissn
0011-4162issn
2326-6929pii
NJ_0C00306Ejournal_volume
96pub_type
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