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NCT Number: NCT06827938

Multicenter Real-World Study of Hyperthermia in Warts 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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location status: Recruiting

Location contact

Wei Huo, PHD

CONTACT

[email protected]

024-83282524

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The cure rate

    Time frame: Three months

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

  2. The cure rate

    Time frame: Six months

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

  3. The recurrence rate

    Time frame: Three months

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

  4. The recurrence rate

    Time frame: Six months

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

Secondary outcomes

  1. The rate of adverse reaction

    Time frame: Three months

    During treatment, adverse reactions and the incidence of treatment-related adverse reactions were recorded.

  2. The rate of adverse reaction

    Time frame: Six months

    During treatment, adverse reactions and the incidence of treatment-related adverse reactions were recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Huo, Doctor

CONTACT

[email protected]

024-83282524

Sponsors and collaborators

Lead sponsor

First Hospital of China Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 14, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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