Efficacy and Tolerability of Topical LFX453 for External Genital Warts
NCT ID: NCT02482428
Last Updated: 2021-01-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
88 participants
INTERVENTIONAL
2015-05-12
2016-05-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LFX453 0.1% NMC
LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
Investigational Treatment
Applied twice daily for up to 12 weeks
LLFX453 0.15% LCC
LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
Investigational Treatment
Applied twice daily for up to 12 weeks
Vehicle to NMC
Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
Investigational Treatment
Applied twice daily for up to 12 weeks
Vehicle to LCC
Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
Investigational Treatment
Applied twice daily for up to 12 weeks
Aldara
Aldara 5% cream 3 applications per week for a maximum of 16 weeks
Aldara
Applied 3 times a week for 16 weeks
Interventions
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Investigational Treatment
Applied twice daily for up to 12 weeks
Aldara
Applied 3 times a week for 16 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
MALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Arlington Heights, Illinois, United States
Countries
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Related Links
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A Plain Language Trial Summary is available on novartisclinicaltrials.com
Other Identifiers
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CLFX453X2202
Identifier Type: -
Identifier Source: org_study_id
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