Efficacy and Tolerability of Topical LFX453 for External Genital Warts

Novartis

Status and phase: Completed; Phase 2

Conditions: External Genital Warts

Treatments: Drug: Investigational Treatment; Drug: Aldara

Study type: Interventional

Funder types: Industry

Identifiers

NCT02482428

CLFX453X2202

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 5 patient groups, including a placebo group

LFX453 0.1% NMC

Experimental group

Description:

LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks

Treatment:

Drug: Investigational Treatment

LLFX453 0.15% LCC

Experimental group

Description:

LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks

Treatment:

Drug: Investigational Treatment

Vehicle to NMC

Placebo Comparator group

Description:

Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks

Treatment:

Drug: Investigational Treatment

Vehicle to LCC

Placebo Comparator group

Description:

Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks

Treatment:

Drug: Investigational Treatment

Aldara

Active Comparator group

Description:

Aldara 5% cream 3 applications per week for a maximum of 16 weeks

Treatment:

Drug: Aldara