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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controllable infrared bioeffect system for cutaneous warts | Experimental | 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 | Active Comparator | Liquid nitrogen crytotherapy at days 1, 15, 30. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liquid nitrogen | Device | As an active comparator, for patients with cutaneous warts, liquid nitrogen crytherapy is applied |
|
| 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 |
| 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 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Xinghua Gao | No. 1 Hospital of China Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No. 1 Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36804149 | Derived | Qi RQ, Zhou J, Xiao B, Xu H, Qiao S, Zhu P, Xia L, Yang Y, Zhang L, Yan H, He C, Sun Y, Niu X, Zhang Y, Fu L, Wang X, Chen HD, Li S, Gao XH. Reprint of: Clearance of multiple cutaneous warts by targeting a single lesion: A randomized comparative evaluation of mild local hyperthermia versus cryotherapy. J Am Acad Dermatol. 2023 Mar;88(3):647-649. doi: 10.1016/j.jaad.2023.02.001. Epub 2023 Feb 18. No abstract available. |
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| ID | Term |
|---|---|
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
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| controllable infrared bioeffect system | Device | As an experimental arm, for patients with cutaneous warts |
|
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 |
| D014947 | Wounds and Injuries |