Conditions: External Genital Warts
Keywords: human papilloma virus (HPV), Genital Warts, Sexually transmitted disease (STD), viral disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 88
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks arm 2: LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks arm 3: Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks arm 4: Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks arm 5: Aldara 5% cream 3 applications per week for a maximum of 16 weeks

Interventions: intervention 1: Investigational Treatment intervention 2: Aldara
Intervention descriptions: intervention 1: Applied twice daily for up to 12 weeks intervention 2: Applied 3 times a week for 16 weeks

Protocol document: