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临床试验/NCT05146895
NCT05146895Unknown不适用

Evaluation of Local Hyperthermia for the Treatment of Flat Warts After 4 Months: a Single-center, Single-blind, Randomized Controlled Trial

First Hospital of China Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年10月20日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Active Comparator

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

发起方
First Hospital of China Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gao Xinghua

professor

First Hospital of China Medical University

研究点 (1)

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