Study of the Safety and Effectiveness of Candin for the Treatment of Common Warts
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Number of Participants With Complete Resolution of Primary Injected Wart
研究概览
简要总结
The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at a 0.3 ml dose level at up to 6 monthly injections for treating common warts (Verruca vulgaris).
详细描述
The primary objective of this study is to determine the safety of Candin® (Candida albicans Skin Test Antigen) at either 0.3 mL dose levels at up to 6 monthly injections (a maximal, cumulative dose of 1.9 mL, including the delayed-type hypersensitivity (DTH) test) for treating common warts (Verruca vulgaris). A secondary objective is to understand the relative effectiveness of the 0.3 dose level for treating common warts, both those that were injected and those that were not injected as well as other types of warts that were not injected to allow a determination of appropriate dose levels to use in a future dose-ranging efficacy trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have at least 3 and not more than 10 common warts not located on the palms or digits
- •Positive DTH response to Candin® required
排除标准
- •No previous medical treatment for warts other than OTC
- •No immunocompromising medical conditions or medicines allowed
- •No preexisting inflammatory conditions at treatment site allowed
结局指标
主要结局
Number of Participants With Complete Resolution of Primary Injected Wart
时间窗: Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months
次要结局
- Number of Participants With Complete Resolution of the Primary Injected Wart by Number of Injection Visits(Monthly evaluations during injection visit for up to 5 months, the follow up visits at 1 and 4 months after last dose for a total of approximately 9 months)