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

NCT06827938 | Recruiting

• 1 other identifier: AF-SOP-07-1.2-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Warts

Keywords

warts; local hyperthermia

Outcome Measures

Primary Outcomes (4)

• The cure rate

  Three months after treatment, the overall cure rate of skin lesions is assessed.

  Three months

• The cure rate

  Six months after treatment, the overall cure rate of skin lesions is assessed.

  Six months

• The recurrence rate

  Three months after treatment, the recurrence rate of skin lesions is assessed.

  Three months

• The recurrence rate

  Six months after treatment, the recurrence rate of skin lesions ie assessed.

  Six months

Secondary Outcomes (2)

• The rate of adverse reaction

  Three months

• The rate of adverse reaction

  Six months

Study Arms (1)

Hyperthermia group

OTHER

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

Interventions

YY-WRY-V01 Infrared thermotherapy apparatus DEVICE

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.

Hyperthermia group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Sites (1)

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Wei Huo, Doctor

CONTACT

024-83282524; huozhongfang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 14, 2025
• Study Start: July 10, 2024
• Primary Completion (Estimated): July 10, 2027
• Study Completion (Estimated): July 10, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)