Evaluation of Local Hyperthermia for the Treatment of Flat Warts After 4 Months: a Single-center, Single-blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- clearance rates of HPV
研究概览
简要总结
flat warts are a superficial viral skin disease, extremely common in childhood.Treatment of warts is often difficult and involves different destructive procedures.Although several pharmacological and physical topical treatments are available (keratolytic agents, electrosurgery, cryotherapy, carbon dioxide laser), results are often unsatisfactory in terms of efficacy (frequent recurrence) and cosmetic outcome (scars, inflammatory reactions, transient or permanent hyper- or hypopigmentation).
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 evaluation local hyperthermia in the treatment of flat warts Appropriate control arms were designed for different conditions.
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
- 12 Years 至 65 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •12-65 years old;
- •diagnosis confirmed;
- •signed informed consent
排除标准
- •Pregnant woman;
- •Local or systematic treatment within 3 months;
- •Comorbidity of other severe gynecological inflammation,
- •Infection, or tumor;
- •Comorbidity of other serious illnesses;
- •No guarantee of timely treatment and follow-up
研究组 & 干预措施
Local Hyperthermia at 44℃ for falt warts
Local hyperthermia at 44℃ for 30 mins on one lesion region, at days of 1,2,3, 15, 16, 21 and 28.
干预措施: Local Hyperthermia at 44℃ (Device)
Imiquimod for Flat Warts
Miquimod treatment: 3 times a week for 1 month
干预措施: Imiquimod treatment (Drug)
结局指标
主要结局
clearance rates of HPV
时间窗: 3 months after the last time of treatment
to evaluate the clearance rates of all lesions in different treatment groups 3 month after treatment.
次要结局
- effective rates of HPV(3 months after the last time of treatment)
研究者
Gao Xinghua
professor
First Hospital of China Medical University
