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

August 9, 2025 updated by: Gao Xinghua, First Hospital of China Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • The First Affiliated Hospital of China Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Hyperthermia group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cure rate
Time Frame: Three months
Three months after treatment, the overall cure rate of skin lesions is assessed.
Three months
The cure rate
Time Frame: Six months
Six months after treatment, the overall cure rate of skin lesions is assessed.
Six months
The recurrence rate
Time Frame: Three months
Three months after treatment, the recurrence rate of skin lesions is assessed.
Three months
The recurrence rate
Time Frame: Six months
Six months after treatment, the recurrence rate of skin lesions ie assessed.
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of adverse reaction
Time Frame: Three months
During treatment, adverse reactions and the incidence of treatment-related adverse reactions were recorded.
Three months
The rate of adverse reaction
Time Frame: Six months
During treatment, adverse reactions and the incidence of treatment-related adverse reactions were recorded.
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Hospital of China Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2024

Primary Completion (Estimated)

July 10, 2027

Study Completion (Estimated)

July 10, 2027

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

February 14, 2025

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 9, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AF-SOP-07-1.2-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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