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)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Complete Clearance of Disease at Week 14
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
LFX453 0.1% NMC
LFX453 0.1% nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
干预措施: Investigational Treatment (Drug)
LLFX453 0.15% LCC
LFX453 0.15% liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
干预措施: Investigational Treatment (Drug)
Vehicle to NMC
Vehicle to nanomedicinal cream (NMC) Twice daily applications for a maximum of 12 weeks
干预措施: Investigational Treatment (Drug)
Vehicle to LCC
Vehicle to liquid crystal cream (LCC) Twice daily applications for a maximum of 12 weeks
干预措施: Investigational Treatment (Drug)
Aldara
Aldara 5% cream 3 applications per week for a maximum of 16 weeks
干预措施: Aldara (Drug)
结局指标
主要结局
Complete Clearance of Disease at Week 14
时间窗: Week 14
Number of participants achieving complete clearance of genital warts at Week 14
Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 30 Weeks
时间窗: 30 weeks
Number of participants with at least one AE/SAE in the category up to 30 weeks
次要结局
- 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)