Multicenter Real-World Study of Hyperthermia in Warts of Special Population

Official title

Multicenter Real-World Study of Hyperthermia in Skin/Mucosal HPV Infection of Special Population

Overview

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.

Interventions

• 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.

Primary outcome measures

• The cure rate [Time frame: Three months]
• The cure rate [Time frame: Six months]
• The recurrence rate [Time frame: Three months]
• The recurrence rate [Time frame: Six months]

Secondary outcome measures (2)

• The rate of adverse reaction [Time frame: Three months]
• The rate of adverse reaction [Time frame: Six months]

Eligibility criteria

Inclusion criteria

• Pregnant women with viral warts
• Diagnosis of AIDS with viral warts
• Autoimmune disease patients with viral warts
• Diabetic patients with viral warts
• Patients with viral warts who are currently being treated with immunosuppressants
• Children with viral warts
• The subject or legal guardian is able to understand and sign the informed consent/consent to participate in the study

Exclusion criteria

• The subject suffers from tumor or other serious disease and cannot complete this clinical study
• Timely treatment and follow-up cannot be guaranteed due to personal or other objective reasons

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of China Medical University — Shenyang

Identifiers

NCT: NCT06827938 · AF-SOP-07-1.2-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗