Efficacy and Tolerability of Topical LFX453 for External Genital Warts
Status:
Completed
Trial end date:
2016-05-31
Target enrollment:
Participant gender:
Summary
The LFX453X2202 study tested the investigational drug LFX453 against placebo for safety,
tolerability, and efficacy in treating genital warts in circumcised men, in parallel with an
additional open label arm using imiquimod 5%.
During the study the patients received either LFX453, placebo or active comparator and the
tolerability and safety was assessed continuously through local tolerability assessments and
adverse event recorded. Efficacy was clinical evaluations and lesion count. During the study
biopsies were taken for analysis of pharmacokinetics and biomarkers. Blood samples were taken
for safety, pharmacokinetics (PK), and biomarkers.