Phase 2
N=88
Efficacy and Tolerability of Topical LFX453 for External Genital Warts
External Genital Warts
Bottom Line
View on ClinicalTrials.gov: NCT02482428 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Complete Clearance of Disease at Week 14 — 1; 0; 0; 0 participants — p=0.862
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Investigational Treatment (Drug); Aldara (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Clearance of Disease at Week 14 |
1; 0; 0; 0 | 0.862 |
| PRIMARY Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 30 Weeks |
3; 5; 3; 2; 10; 0 | — |
| 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 |
2; 1; 0; 3 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02482428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.