Efficacy and Tolerability of Topical LFX453 for External Genital Warts

December 9, 2020 updated by: Novartis Pharmaceuticals

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LFX453 0.1% NMC
LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
Drug: Investigational Treatment
Applied twice daily for up to 12 weeks
EXPERIMENTAL: LLFX453 0.15% LCC
LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
Drug: Investigational Treatment
Applied twice daily for up to 12 weeks
PLACEBO_COMPARATOR: Vehicle to NMC
Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
Drug: Investigational Treatment
Applied twice daily for up to 12 weeks
PLACEBO_COMPARATOR: Vehicle to LCC
Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
Drug: Investigational Treatment
Applied twice daily for up to 12 weeks
ACTIVE_COMPARATOR: Aldara
Aldara 5% cream 3 applications per week for a maximum of 16 weeks
Drug: Aldara
Applied 3 times a week for 16 weeks
Other Names:
  • imiquimod

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Clearance of Disease at Week 14
Time Frame: 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
Time Frame: 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
Time Frame: End of Treatment (EOT) Week 12 or Week 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 12, 2015

Primary Completion (ACTUAL)

May 31, 2016

Study Completion (ACTUAL)

May 31, 2016

Study Registration Dates

First Submitted

May 26, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (ESTIMATE)

June 26, 2015

Study Record Updates

Last Update Posted (ACTUAL)

January 5, 2021

Last Update Submitted That Met QC Criteria

December 9, 2020

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLFX453X2202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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