External Genital WartsPhase 2NCT02482428

Efficacy and Tolerability of Topical LFX453 for External Genital Warts

A Phase 2 study testing Investigational Treatment and Aldara in people with External Genital Warts, run by Novartis Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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%. Read more about this study

Who is it for?: Ages 18 to 60 years, men only
Conditions the study is for: External Genital Warts
What is being tested?: Investigational Treatment and Aldara
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 88 participants
Where: 1 siteUnited States
Study dates: 12 May 2015to 31 May 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Men only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 17Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Novartis Investigative Site
Arlington Heights, Illinois, 60005

Other trials in United States

About this study

Official title: 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)

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
Being tested: Investigational Treatment, Aldara
Keywords: human papilloma virus (HPV), Genital Warts, Sexually transmitted disease (STD), viral disease
Medical subject headings: Papillomavirus Infections, Condylomata Acuminata, Sexually Transmitted Diseases, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Investigational TreatmentDrug
Applied twice daily for up to 12 weeks
AldaraDrug
Also called imiquimod
Applied 3 times a week for 16 weeks

Study groups in NCT02482428
Study group	Role	What they receive
LFX453 0.1% NMC	Experimental	LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks Receives: Drug: Investigational Treatment
LLFX453 0.15% LCC	Experimental	LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks Receives: Drug: Investigational Treatment
Vehicle to NMC	Placebo comparator	Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks Receives: Drug: Investigational Treatment
Vehicle to LCC	Placebo comparator	Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks Receives: Drug: Investigational Treatment
Aldara	Active comparator	Aldara 5% cream 3 applications per week for a maximum of 16 weeks Receives: Drug: Aldara

What is being measured

The primary outcome is the main question the study is designed to answer.

Complete Clearance of Disease at Week 14
Number of participants achieving complete clearance of genital warts at Week 14
Measured: 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
Measured: 30 weeks

Secondary outcomes (1)

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
Measured: End of Treatment (EOT) Week 12 or Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 May 201531 May 2016

First posted26 Jun 2015 (estimated)
Study start12 May 2015
Primary completion31 May 2016
Study completion31 May 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for External Genital WartsStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02482428
Sponsor's protocol ID: CLFX453X2202
Status last verified: Mar 2019
First submitted: 26 May 2015
Last updated: 5 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT02482428
Acronym / sponsor ID: CLFX453X2202
Conditions: External Genital Warts
Keywords: human papilloma virus (HPV), Genital Warts, Sexually transmitted disease (STD), viral disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 12 May 2015 (actual)
Primary completion: 31 May 2016 (actual)
Study completion: 31 May 2016 (actual)
First posted: 26 Jun 2015 (estimated)
Results: Posted 23 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
LFX453 0.1% NMC	Experimental	Drug: Investigational TreatmentLFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
LLFX453 0.15% LCC	Experimental	Drug: Investigational TreatmentLFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
Vehicle to NMC	Placebo comparator	Drug: Investigational TreatmentVehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
Vehicle to LCC	Placebo comparator	Drug: Investigational TreatmentVehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
Aldara	Active comparator	Drug: AldaraAldara 5% cream 3 applications per week for a maximum of 16 weeks

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Investigational TreatmentApplied twice daily for up to 12 weeks	Drug	LFX453 0.1% NMC, LLFX453 0.15% LCC, Vehicle to LCC, Vehicle to NMC
AldaraAlso: imiquimodApplied 3 times a week for 16 weeks	Drug	Aldara

Primary outcome

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

1 secondary outcome

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
Time frame: End of Treatment (EOT) Week 12 or Week 16

Results and safety

Results posted to the registry on 23 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LFX453 0.1% NMC	24	15
LFX453 0.15% LCC	22	10
Vehicle to NMC	10	9
Vehicle to LCC	10	8
Aldara	22	15

Primary outcome: Complete Clearance of Disease at Week 14

Time frame: Week 14. Number. Unit: participants

Measure	LFX453 0.1% NMC n = 15	LFX453 0.15% LCC n = 10	Combined Vehicle n = 17	Aldara n = 16
Value	1	0	0	0

LFX453 0.1% NMC vs Combined Vehicle: Mean Difference (Net): 0.05 (90% CI -0.03 to 0.20), p = 0.862, Posterior mean
LFX453 0.15% LCC vs Combined Vehicle: Mean Difference (Net): 0.02 (90% CI -0.07 to 0.19), p = 0.541, posterior mean

Population analysed: 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.

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

Time frame: 30 weeks. Number. Unit: participants

Measure	LFX453 0.1% NMC n = 24	LFX453 0.15% LCC n = 22	Vehicle to NMC n = 10	Vehicle to LCC n = 10	Aldara n = 22
Adverse Events (AEs)	3	5	3	2	10
Serious Adverse Events (SAEs)	0	0	0	0	0

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LFX453 0.1% NMC	0 of 24 (0%)	3 of 24 (12.5%)	Not reported
LFX453 0.15% LCC	0 of 22 (0%)	5 of 22 (22.7%)	Not reported
Vehicle to NMC	0 of 10 (0%)	3 of 10 (30%)	Not reported
Vehicle to LCC	0 of 10 (0%)	2 of 10 (20%)	Not reported
Aldara	0 of 22 (0%)	10 of 22 (45.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Investigational Treatment and Aldara in people with External Genital Warts, run by Novartis Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Clearance of Disease at Week 14 (time frame: Week 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02482428.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.