An interventional study of YY-WRY-V01 Infrared thermotherapy apparatus in Warts, sponsored by First Hospital of China Medical University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by First Hospital of China Medical University · Not applicable, Interventional, and Treatment
Hyperthermia refers to treating diseases with temperatures beyond normal body temperature (39-45℃), and moxibustion therapy of traditional Chinese medicine belongs to the category of hyperthermia. It has been reported at home and abroad that the local temperature of 44℃ can effectively mobilize the body's immunity and remove HPV infection lesions, such as condyloma acuminatum and verruca vulgaris. Our research group conducted randomized controlled experiments on patients with viral warts in the early clinical practice, and the cure rate of the hyperthermia group reached 45-55%, which was superior to the traditional method in the aspects of no trauma, low recurrence rate, easy to tolerate and so on. Our research group's preliminary research on hyperthermia of viral warts has been included in the British Medical Association's guidelines for viral warts therapy. The equipment our research group developed has been obtained the medical device registration certificate, and is in the process of national promotion. Hyperthermia is to mobilize systemic immunity through local warm heat, the preliminary clinical study of the research group shows that the therapeutic effect of hyperthermia is usually "all or none": "all" that is, after hyperthermia, all viral warts are removed, including non-treatment lesions;"None" means that some patients with viral warts do not respond to hyperthermia. Cellular immunity plays a very important role in the removal of warts. At present, some special clinical patients such as pregnant women, children, patients with autoimmune diseases, diabetes, immunosuppressants after organ transplantation and other patients with skin/mucosal HPV infection, their warts show more extensive proliferation or a longer and repeated course of disease, treatment resistance, etc. It has increased the difficulty of clinical treatment, and the specific mechanism is still unclear. Therefore, for these special populations, how to further enhance the therapeutic effect of hyperthermia is the top priority of current research.
In view of the above findings, this research group intends to study the efficacy and safety of hyperthermia in the treatment of viral warts in the special population (pregnant women, children, patients with autoimmune diseases, diabetes, and immunosuppressants after organ transplantation, etc.) in a multicenter real-world study of skin/mucosal HPV infection in the special population.
171 studies on the registry are indexed under Warts; 35 are open to participants now.
This study's planned enrollment of 400 is above the median of 70 across 155 interventional studies indexed under Warts.
Browse Warts studies →First Hospital of China Medical University is the lead sponsor of 62 studies on the registry; 34 are open to participants now.
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Infrared hyperthermia(44±1℃) device for 3 consecutive days (times / day), each treatment for 30 minutes After 7-10 days, the lesions of the same target were treated continuously for 2 days (times / day), and then treat every 7-10 days, the method was the same as before. Lesion changes were assessed after 15 treatments.
Device: YY-WRY-V01 Infrared thermotherapy apparatus
Infrared hyperthermia(44±1℃) device for 3 consecutive days (times / day), each treatment for 30 minutes After 7-10 days, the lesions of the same target were treated continuously for 2 days (times / day), and then treat every 7-10 days, the method was the same as before. Lesion changes were assessed after 15 treatments.
The cure rate
Three months after treatment, the overall cure rate of skin lesions is assessed.
Time frame: Three months
The cure rate
Six months after treatment, the overall cure rate of skin lesions is assessed.
Time frame: Six months
The recurrence rate
Three months after treatment, the recurrence rate of skin lesions is assessed.
Time frame: Three months
The recurrence rate
Six months after treatment, the recurrence rate of skin lesions ie assessed.
Time frame: Six months
The rate of adverse reaction
During treatment, adverse reactions and the incidence of treatment-related adverse reactions were recorded.
Time frame: Three months
The rate of adverse reaction
During treatment, adverse reactions and the incidence of treatment-related adverse reactions were recorded.
Time frame: Six months
Plan to share: No
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First Hospital of China Medical University