NCT04253912Unknown2 期
A Phase 2, Double-Blind, Randomized, Parallel Group, Placebo-Controlled, Study to Evaluate Topical 2% Povidone-Iodine Gel (VBP-245) in Subjects With Verruca Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Decrease in wart diameter (mm)
研究概览
简要总结
This is a multi-center, randomized, double-blind, placebo-controlled phase 2 study in subjects 8 years of age and older who present with verruca vulgaris (common warts) and desire treatment. Subjects may have up to a total of 6 common warts located on their trunk or extremities that will be treated with study medication and followed throughout the study protocol therapy. All warts will be treated two times per day (BID) for12 weeks. Approximately 90 subjects will be enrolled in this study.
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
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
- •Male or female ≥ 8 years old.
- •Subject has a clinical diagnosis of verruca vulgaris (common warts).
- •Subject has up to 6 warts located on the trunk or extremities
排除标准
- •Subject has clinically atypical warts on the trunk or extremities.
- •Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.)
- •Subject has periungual, subungual, genital, anal, mosaic, plantar, flat, or filiform wart identified as a wart for study treatment.
研究组 & 干预措施
VBP-245
Experimental
Topical 2% Povidone-Iodine Gel
干预措施: VBP-245 (Drug)
Control
Placebo Comparator
Placebo Gel (no Povidone-Iodine)
干预措施: Placebo Gel (no Povidone-Iodine) (Drug)
结局指标
主要结局
Decrease in wart diameter (mm)
时间窗: 12 weeks
次要结局
- Resolution of wart(12 weeks)
- Application Site Reaction Adverse Events(12 weeks)
研究者
研究点 (1)
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