NCT02482428

Efficacy and Tolerability of Topical LFX453 for External Genital Warts

A Randomized, Vehicle Controlled, Active Comparator, Parallel Group Study to Evaluate Efficacy, Safety, and Tolerability of Topical LFX453 Formulations in Patients With External Genital Warts (EGWs)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• External Genital Warts

Interventions

Type	Name	Description
DRUG	Investigational Treatment	Applied twice daily for up to 12 weeks
DRUG	Aldara	Applied 3 times a week for 16 weeks

Timeline

• Start date: 2015-05-12
• Primary completion: 2016-05-31
• Completion: 2016-05-31
• First posted: 2015-06-26
• Last updated: 2021-01-05
• Results posted: 2017-06-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study