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Completed

NCT Number: NCT02482428

Efficacy and Tolerability of Topical LFX453 for External Genital Warts

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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Key information

Conditions

External Genital Warts Communicable Diseases Condylomata Acuminata DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases Warts

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site

Arlington Heights, Illinois, 60005, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Investigational Treatment

Drug

Applied twice daily for up to 12 weeks

Aldara

Drug

Applied 3 times a week for 16 weeks

Other names: imiquimod

Primary outcomes

  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 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

    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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 26, 2015
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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