Cutaneous Warts, Human Papilloma Virus
Conditions
Keywords
hyperthermia, human papilloma virus, cutaneous warts
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.
Interventions
DEVICEliquid nitrogen
As an active comparator, for patients with cutaneous warts, liquid nitrogen crytherapy is applied
DEVICEcontrollable infrared bioeffect system
As an experimental arm, for patients with cutaneous warts
Sponsors
First Hospital of China Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
China
Outcome results
None listed