ClinicalTrials.gg
RecruitingNCT06827938Updated Aug 14, 2025

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

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

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jul 2024, registered Feb 2025).
  • Started Jul 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Non-randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Warts

Browse trials for

Keywords

  • warts
  • local hyperthermia
03

In context

Warts

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 →

Lead sponsor

First Hospital of China Medical University is the lead sponsor of 62 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

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.

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.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceYY-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.

06

What researchers measure

Primary outcomes

  1. The cure rate

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

    Time frame: Three months

  2. The cure rate

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

    Time frame: Six months

  3. The recurrence rate

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

    Time frame: Three months

  4. The recurrence rate

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

    Time frame: Six months

Secondary outcomes

  1. The rate of adverse reaction

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

    Time frame: Three months

  2. The rate of adverse reaction

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

    Time frame: Six months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06827938
Lead sponsor
First Hospital of China Medical University
Responsible party
Gao Xinghua (Professor, First Hospital of China Medical University) — Principal investigator
First posted
Feb 14, 2025
Start date
Jul 10, 2024
Primary completion
Jul 10, 2027 (estimated)
Completion
Jul 10, 2027 (estimated)
Last update
Aug 14, 2025

Study contacts

Wei Huo, Doctor
Contact
huozhongfang@163.com
024-83282524

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion