Infrared Bioeffect System for the Treatment of Cutaneous Warts
- Conditions
- Cutaneous WartsHuman Papilloma Virus
- Interventions
- Device: controllable infrared bioeffect systemDevice: liquid nitrogen
- Registration Number
- NCT03734003
- Lead Sponsor
- First Hospital of China Medical University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
Not provided
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Controllable infrared bioeffect system for cutaneous warts controllable infrared bioeffect system Controllable infrared bioeffect system at 44±2℃ for 30 mins on target lesion, at days of 1, 2, 3, 15, 16, 23, 30. Common warts, plantar warts, and condyloma acuminata Liquid nitrogen cryotherapy for cutaneous warts liquid nitrogen Liquid nitrogen crytotherapy at days 1, 15, 30.
- Primary Outcome Measures
Name Time Method Recovery rate of cutaneous warts 3 months after the last time of treatment to evaluate the clearance rate in different treatment groups 3 months after treatment
- Secondary Outcome Measures
Name Time Method Clearance rate of target lession 3 months after the last time of treatment to evaluate the recovery rate of target lession in different treatment groups 3 months after treatment
the visual analogue score (VAS) of pain 3 months after the last time of treatment to evaluate the score of VAS (0 score represents no pain; 10 score represents sharp pain) in different treatment groups 3 months after treatment
Clearance rate of virus 3 months after thelast time of treatment to evaluate the clearance rate of virus in different treatment groups 3 months after treatment
Clearance rate of non-target lession 3 months after the last time of treatment to evaluate the recovery rate of non-target lession in different treatment groups 3 months after treatment
Trial Locations
- Locations (1)
No. 1 Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China