Neoplasms

All Conditions

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Papilloma

Sexually Transmitted Diseases

Virus Diseases

Warts

Condylomata Acuminata

Communicable Diseases

Papillomavirus Infections

DNA Virus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

Sexually Transmitted Diseases, Viral

Genital Diseases

Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Imiquimod

Immunomodulating Agents

Immunologic Factors

Adjuvants, Immunologic

Interferons

LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks

LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks

Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks

Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks

Aldara 5% cream 3 applications per week for a maximum of 16 weeks

Investigational Treatment

Aldara

Novartis Pharmaceuticals

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.

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)

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Number of participants achieving complete clearance of genital warts at Week 14

Number of participants with at least one AE/SAE in the category up to 30 weeks

Number of Participants that had partial clearance rate of at least 75 percent reduction in External Genital Wart (EGW)s count at end of treatment (EOT) Week 12 or 16

LFX453 0.1% NMC

LFX453 0.15% LCC

Vehicle to NMC

Vehicle to LCC

Total

Age, Continuous

Sex: Female, Male

Study Director

Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications

Combined Vehicle

Pharmacodynamics (PD) data sets included all randomized patients For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.

Complete Clearance of Disease at Week 14

Adverse Events (AEs)

Serious Adverse Events (SAEs)

The safety analysis set included all patients that received any study drug. For Safety \& Tolerability only the 2 vehicles have separate analysis.

Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 30 Weeks

Number of Participants That Had Partial Clearance Rate of at Least 75 Percent Reduction in External Genital Wart (EGW)s Count at End of Treatment (EOT) Week 12 or 16

Spots Global Cancer Trial Database for human papilloma virus (hpv), genital warts, sexually transmitted disease (std), viral disease