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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LFX453 0.1% NMC | Experimental | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks |
|
| LLFX453 0.15% LCC | Experimental | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks |
|
| Vehicle to NMC | Placebo Comparator | Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks |
|
| Vehicle to LCC | Placebo Comparator | Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks |
|
| Aldara | Active Comparator | Aldara 5% cream 3 applications per week for a maximum of 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Treatment | Drug | Applied twice daily for up to 12 weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Arlington Heights | Illinois | 60005 | United States |
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| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
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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
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A total of 88 patients were randomized and treated in the study
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| ID | Title | Description |
|---|---|---|
| FG000 | LFX453 0.1% NMC | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks |
| FG001 | LFX453 0.15% LCC | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks |
| FG002 | Vehicle to NMC | Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks |
| FG003 | Vehicle to LCC | Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks |
| FG004 | Aldara | Aldara 5% cream 3 applications per week for a maximum of 16 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LFX453 0.1% NMC | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks |
| BG001 | LFX453 0.15% LCC | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Clearance of Disease at Week 14 | Number of participants achieving complete clearance of genital warts at Week 14 | 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. | Posted | Number | participants | Week 14 |
|
Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LFX453 0.1% NMC | LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D003218 | Condylomata Acuminata |
| D012749 | Sexually Transmitted Diseases |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
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| ID | Term |
|---|---|
| D035703 | Therapies, Investigational |
| D000077271 | Imiquimod |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Aldara | Drug | Applied 3 times a week for 16 weeks |
|
|
| Physician Decision |
|
| protocol deviation |
|
| subject/guardian decision |
|
| BG002 | Vehicle to NMC | Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks |
| BG003 | Vehicle to LCC | Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks |
| BG004 | Aldara | Aldara 5% cream 3 applications per week for a maximum of 16 weeks |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Combined Vehicle | Vehicle to nanomedicinal cream (NMC) and Vehicle to liquid crystal cream (LCC) Twice daily applications |
| OG003 | Aldara | Aldara 5% cream 3 applications per week for a maximum of 16 weeks |
|
|
|
| Primary | 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 | The safety analysis set included all patients that received any study drug. For Safety & Tolerability only the 2 vehicles have separate analysis. | Posted | Number | participants | 30 weeks |
|
|
|
| Secondary | 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 | 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. | Posted | Number | participants | End of Treatment (EOT) Week 12 or Week 16 |
|
|
|
| 0 |
| 24 |
| 3 |
| 24 |
| EG001 | LFX453 0.15% LCC | LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks | 0 | 22 | 5 | 22 |
| EG002 | Vehicle to NMC | Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks | 0 | 10 | 3 | 10 |
| EG003 | Vehicle to LCC | Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks | 0 | 10 | 2 | 10 |
| EG004 | Aldara | Aldara 5% cream 3 applications per week for a maximum of 16 weeks | 0 | 22 | 10 | 22 |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| COELIAC DISEASE | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| APPLICATION SITE ERYTHEMA | General disorders | MedDRA | Systematic Assessment |
|
| APPLICATION SITE PAIN | General disorders | MedDRA | Systematic Assessment |
|
| APPLICATION SITE PRURITUS | General disorders | MedDRA | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| TINEA CRURIS | Infections and infestations | MedDRA | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA | Systematic Assessment |
|
| AMYLASE INCREASED | Investigations | MedDRA | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA | Systematic Assessment |
|
| BLOOD CREATININE INCREASED | Investigations | MedDRA | Systematic Assessment |
|
| CARDIAC MURMUR | Investigations | MedDRA | Systematic Assessment |
|
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA | Systematic Assessment |
|
| HAEMOGLOBIN URINE | Investigations | MedDRA | Systematic Assessment |
|
| LIPASE INCREASED | Investigations | MedDRA | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
|
| SINUS HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA | Systematic Assessment |
|
| SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| GLYCOSURIA | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| HAEMATURIA | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| GENITAL RASH | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| PRURITUS GENITAL | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| SCROTAL ERYTHEMA | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| SCROTAL ULCER | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| WHEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Serious Adverse Events (SAEs) |
|