Efficacy and Tolerability of Topical LFX453 for External Genital Warts

• ClinicalTrials.gov Identifier: NCT02482428
• Recruitment Status: Completed
• First Posted: June 26, 2015
• Results First Posted: June 23, 2017
• Last Update Posted: January 5, 2021
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

Brief 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%.

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.

Condition or disease	Intervention/treatment	Phase
External Genital Warts	Drug: Investigational Treatment; Drug: Aldara	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: May 12, 2015
• Actual Primary Completion Date: May 31, 2016
• Actual Study Completion Date: May 31, 2016

Arms and Interventions

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 Name: imiquimod

Outcome Measures

Primary Outcome Measures :

1. Complete Clearance of Disease at Week 14 [ Time Frame: Week 14 ]
   Number of participants achieving complete clearance of genital warts at Week 14
2. 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

Secondary Outcome Measures :

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 [ 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Illinois

Novartis Investigative Site

Arlington Heights, Illinois, United States, 60005

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

More Information

Additional Information:

A Plain Language Trial Summary is available on novartisclinicaltrials.com 

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02482428
• Other Study ID Numbers: CLFX453X2202
• First Posted: June 26, 2015
• Results First Posted: June 23, 2017
• Last Update Posted: January 5, 2021
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

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

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

human papilloma virus (HPV), Genital Warts, Sexually transmitted disease (STD), viral disease

Additional relevant MeSH terms:

Warts; Condylomata Acuminata; Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Imiquimod; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs; Antineoplastic Agents; Interferon Inducers