Efficacy and Tolerability of Topical LFX453 for External Genital Warts

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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External Genital Warts

Intervention / Treatment
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* Drug: Investigational Treatment
* Drug: Aldara


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Circumcised male 18-60 years Clinical diagnosis of external genital warts Agree to remain abstinent or to use condoms during intercourse for the duration of the study Agree to digital photographs of treated area Exclusion Criteria: Any treatment of genital warts within one month of treatment start HPV vaccination presence of warts larger than 200 mm2 Genital herpes within one month of treatment start History of Bowenoid papulosis significant illness within 2 weeks of treatment start use of other investigational drugs known hypersensitivity to study drugs or constituents history of ECG abnormalities History of significant heart conditions Impaired renal function Abnormal liver function History of immunodeficiency disease Drug or alcohol abuse Immunosuppressive therapies Malignancies in the past 5 years hypertrophic scarring

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LFX453 0.1% NMC<br>LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks | Drug: Investigational Treatment<br>* Applied twice daily for up to 12 weeks<br>|
| Experimental: LLFX453 0.15% LCC<br>LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks | Drug: Investigational Treatment<br>* Applied twice daily for up to 12 weeks<br>|
| Placebo Comparator: Vehicle to NMC<br>Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks | Drug: Investigational Treatment<br>* Applied twice daily for up to 12 weeks<br>|
| Placebo Comparator: Vehicle to LCC<br>Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks | Drug: Investigational Treatment<br>* Applied twice daily for up to 12 weeks<br>|
| Active Comparator: Aldara<br>Aldara 5% cream 3 applications per week for a maximum of 16 weeks | Drug: Aldara<br>* Applied 3 times a week for 16 weeks<br>* Other names: imiquimod;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Clearance of Disease at Week 14 | Number of participants achieving complete clearance of genital warts at Week 14 | Week 14 | 
| Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 30 Weeks | Number of participants with at least one AE/SAE in the category up to 30 weeks | 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | End of Treatment (EOT) Week 12 or Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human papilloma virus (HPV), Genital Warts, Sexually transmitted disease (STD), viral disease