Infrared Bioeffect System for the Treatment of Cutaneous Warts

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Controllable Infrared Bioeffect Effect for the Treatment of Cutaneous Warts After 3 Months: a Multicenter, Randomized, Open Label Controlled Trial

Conditions
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Cutaneous Warts, Human Papilloma Virus

Intervention / Treatment
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* Device: liquid nitrogen
* Device: controllable infrared bioeffect system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Controllable infrared bioeffect system for cutaneous warts<br>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 | Device: controllable infrared bioeffect system<br>* As an experimental arm, for patients with cutaneous warts<br>|
| Active Comparator: Liquid nitrogen cryotherapy for cutaneous warts<br>Liquid nitrogen crytotherapy at days 1, 15, 30. | Device: liquid nitrogen<br>* As an active comparator, for patients with cutaneous warts, liquid nitrogen crytherapy is applied<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery rate of cutaneous warts | to evaluate the clearance rate in different treatment groups 3 months after treatment | 3 months after the last time of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance rate of target lession | to evaluate the recovery rate of target lession in different treatment groups 3 months after treatment | 3 months after the last time of treatment | 
| Clearance rate of non-target lession | to evaluate the recovery rate of non-target lession in different treatment groups 3 months after treatment | 3 months after the last time of treatment | 
| the visual analogue score (VAS) of pain | to evaluate the score of VAS (0 score represents no pain; 10 score represents sharp pain) in different treatment groups 3 months after treatment | 3 months after the last time of treatment | 
| Clearance rate of virus | to evaluate the clearance rate of virus in different treatment groups 3 months after treatment | 3 months after thelast time of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperthermia, human papilloma virus, cutaneous warts