Evaluation of Controllable Infrared Bioeffect Effect for the Treatment of Cutaneous Warts After 3 Months: a Multicenter, Randomized, Open Label Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Recovery rate of cutaneous warts
研究概览
简要总结
Local hyperthermia at 44℃ can promote some alterations of immulogical indicators. The procedure is convenient in clinic, has high tolerance with less trauma and less pain. Based on domestic and abroad clinical practice, the investigators observed initially that local hyperthermia brought great benefits to cutaneous warts. In comparison with liquid nitrogen, the safety and efficacy of controllable infrared bioeffect system to treat skin disease has been evaluated. This proved it could be used in treatment of skin warts, and clinical trial met the requirements of Standards for quality control of clinical trials on medical devices, and can be used in product registration and declaration.
详细描述
Mild local Hyperthermia with a certain temperature range has been successfully used in the treatment of some diseases. It has been utilised in the treatment of some neoplasm, fungal and HPV infections. Investigators' study found that local hyperthermia at 44°C could cleared HPV in more than half of the patients with plantar warts. Investigators also note the fact that in patients with multiple lesions, the clearance of the target lesion is commonly followed by clearance of other distant lesions, a phenomenon suggesting that local hyperthermia could aid in establishing a specific immune response to eliminate HPV.So the purpose of the study is to evaluate the safety and efficacy of controllable infrared bioeffect system to treat cutaneous warts. This trial was designed into two groups, one was experimental group (thermal therapy group), the other one was control group (liquid nitrogen cryotherapy group). The ratio of participants was 1:1 in experiment group and control group. The main evaluation indicator was the recovery rate after 4 months of initial treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years old signed informed consent clinical diagnosed HPV induced cutaneous warts no local or systemic therapy within 3 months effective contraception for 6 months after signed informed consent
排除标准
- •HbsAg(+), HCV-Ab(+), HIV-Ab(+) skin lesions associated with other infections pregnant or breast-feeding woman unsuitable to be treated by liquid nitrogen cryotherapy scar diathesis
结局指标
主要结局
Recovery rate of cutaneous warts
时间窗: 3 months after the last time of treatment
to evaluate the clearance rate in different treatment groups 3 months after treatment
次要结局
- Clearance rate of target lession(3 months after the last time of treatment)
- the visual analogue score (VAS) of pain(3 months after the last time of treatment)
- Clearance rate of virus(3 months after thelast time of treatment)
- Clearance rate of non-target lession(3 months after the last time of treatment)
研究者
Gao Xinghua
Professor
First Hospital of China Medical University