NCT01111344已完成3 期
Efficacy of Glizigen-Viudid in the Treatment of External Anogenital Warts in Children and Adolescents.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Time to lesion regression
研究概览
简要总结
The purpose of the study is to assess the efficacy of Glizigen and Viusid administration in the treatment of external anogenital warts in children and adolescents. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons to be recruited and randomized for the study is 76. Variables to be assessed will be: time to disappearance of lesions, reduction of the number of lesions and change in the aspect of lesions.
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
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No previous treatment for anogenital warts
- •Negative serology for HB and HIV.
- •Signed informed consent.
排除标准
- •Pregnancy
- •Treatment with steroids, immune-suppressors, immune-modulators or local or systemic antiviral drugs.
- •Hypersensitivity to Glizigen or Viusid:
结局指标
主要结局
Time to lesion regression
时间窗: 12 weeks
Excellent: Lesion regression before 2 weeks of treatment Good: Lesion regression between 2-5 weeks of treatment Poor: Lesion regression between 5-8 weeks of treatment Bad: No lesion regression after 8 weeks of treatment.
次要结局
- Occurrence of adverse effects within the 12 week treatment period(12 weeks)
- Reduction in the number of lesions(12 weeks)
- Lesion aspect(12 weeks)
研究者
研究点 (2)
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