Efficacy and Tolerability of Topical LFX453 for External Genital Warts
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.
Timeline
- Start
- 2015-05-12
- Primary completion
- 2016-05-31
- Completion
- 2016-05-31
Outcome
Missed primary endpoint
registry analysis (unspecified test); LFX453 0.1% NMC vs Combined Vehicle; p = 0.862 NCT02482428 ↗
registry analysis (unspecified test); LFX453 0.15% LCC vs Combined Vehicle; p = 0.541 NCT02482428 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Imiquimod | Other / unclassified | 5 % | Topical |
| Subject | LFX453 | Unknown | 0.1 % | Topical |
| Subject | LFX453 | Unknown | 0.15 % | Topical |