Efficacy and Tolerability of Topical LFX453 for External Genital Warts

External Genital Warts Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02482428
• Other study ID #: CLFX453X2202
• Status: Completed
• Phase: Phase 2
• Start date: May 12, 2015
• Est. completion date: May 31, 2016

Study information

• Verified date: March 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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%. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: May 31, 2016
• Est. primary completion date: May 31, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Condylomata Acuminata
• External Genital Warts
• Warts

Intervention

Drug:
• Investigational Treatment
Applied twice daily for up to 12 weeks
• Aldara
Applied 3 times a week for 16 weeks

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Arlington Heights	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Clearance of Disease at Week 14	Number of participants achieving complete clearance of genital warts at Week 14	Week 14
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	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	End of Treatment (EOT) Week 12 or Week 16

External Links

•   A Plain Language Trial Summary is available on novartisclinicaltrials.com