NCT03259620已完成3 期
A Phase 3, Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 491
- 试验地点
- 35
- 主要终点
- The Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts Between the Active and Vehicle at Week 18/End of Post-treatment Efficacy Evaluation
研究概览
简要总结
To evaluate the efficacy and safety of six (6) weeks of once daily application of Furosemide Topical Gel 0.125% (CLS006) compared to vehicle in subjects ≥ 2 years of age with nongenital cutaneous common warts (verruca vulgaris).
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have 1 to 6 clearly identifiable common warts located on hands, feet, limbs, and/or trunk
- •Each wart must measure 3 to 10 mm in their longest dimension (diameter) on the epidermal plane of the skin at the baseline visit,
- •Each wart must be present for at least 4 weeks at the baseline visit,
- •Plantar, facial, subungual, and other warts (e.g., flat, genital) are excluded from treatment (i.e., these wart types are excluded from treatment, however the subject is not excluded).
- •Male or female subjects 2 years of age or older
- •Females of childbearing potential who are using a highly effective form of birth control or females of non-childbearing potential
- •Negative in-office urine pregnancy test at Screening and Baseline
- •Subjects free of any clinically significant dermatologic disorder in the treatment area
- •Subjects free of any clinically significant systemic condition which will interfere with the study assessments or increase the risk of AEs
- •Subjects willing to refrain from using other topical products in the treatment area, or prohibited medications for the duration of the study
排除标准
- •Subjects who have used any wart treatments/therapies, prescription or over-the-counter, as follows:
- •Salicylic acid, cantharidin, sinecatechins (VeregenTM), simple occlusion (e.g., duct tape), and/or any other over-the-counter wart-removing products in the treatment area within 4 weeks of the Baseline Visit.
- •Cryotherapy (e.g., treatment with liquid nitrogen), carbon dioxide, electrodessication, laser, surgery, or other forms of mechanical destruction (e.g., emery boards, clippers, debriders, etc.) in the treatment area within 8 weeks of the Baseline Visit.
- •Treatment with immunotherapy (DPCP, DNCB or other), imiquimod, 5-fluorouracil, bleomycin, podophyllin or any other wart immunotherapy or treatment (e.g., Candida antigen) designed to stimulate immune response within 12 weeks of the Baseline Visit.
- •Female subjects who are pregnant, nursing/breastfeeding, or plan to become pregnant within the study period including the follow-up period.
- •Subjects who are immunocompromised.
- •Subjects who have taken, within 30 days prior to the Baseline visit, or require treatment with systemic immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) during the course of the study.
- •Subjects who require ongoing treatment with oral or injectable furosemide.
- •Subjects who have used an investigational drug/device within 30 days of the Baseline visit
- •Subjects with known sensitivities to any of the investigational product ingredients including furosemide (or other sulfonamides).
- •Subjects with clinically relevant/significant abnormal laboratory results, vital signs, ECG, and/or physical findings at Screening and/or Baseline
- •Subjects with a chronic medical condition or clinically significant abnormal physical or laboratory finding(s) that may require the use of a prohibited medication/treatment.
- •Subjects who currently abuse alcohol or drugs or who have a history of chronic alcohol or drug abuse within the past year.
研究组 & 干预措施
CLS006
Experimental
Furosemide Topical Gel, 0.125%
干预措施: CLS006 (Drug)
CLS006 Vehicle
Experimental
Vehicle Topical Gel
干预措施: CLS006 Vehicle (Drug)
结局指标
主要结局
The Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts Between the Active and Vehicle at Week 18/End of Post-treatment Efficacy Evaluation
时间窗: Week 18
次要结局
- The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject(Week 18)
- Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts at Week 12(Week 12)
- The Ratio of the Number of Cleared Warts Out of the Number of Treated Warts for Each Subject at Week 12(Week 12)
- Change From Baseline in Wart Size for Each Subject(Week 18)
研究者
研究点 (35)
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