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Recruiting NCT06827938

NCT06827938 Multicenter Real-World Study of Hyperthermia in Warts of Special Population

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Clinical Trial Summary
NCT ID NCT06827938
Status Recruiting
Phase
Sponsor First Hospital of China Medical University
Condition Warts
Study Type INTERVENTIONAL
Enrollment 400 participants
Start Date 2024-07-10
Primary Completion 2027-07-10

Eligibility & Interventions

Sex All sexes
Min Age N/A
Max Age N/A
Study Type INTERVENTIONAL
Interventions
YY-WRY-V01 Infrared thermotherapy apparatus

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 400 participants in total. It began in 2024-07-10 with a primary completion date of 2027-07-10.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Wei Huo, Doctor

✉ huozhongfang@163.com

📞 024-83282524

Frequently Asked Questions

Who can join the NCT06827938 clinical trial?

This trial is open to participants of all sexes, studying Warts. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06827938 currently recruiting?

Yes, NCT06827938 is actively recruiting participants. Contact the research team at huozhongfang@163.com for enrollment information.

Where is the NCT06827938 trial being conducted?

This trial is being conducted at Shenyang, China.

Who is sponsoring the NCT06827938 clinical trial?

NCT06827938 is sponsored by First Hospital of China Medical University. The trial plans to enroll 400 participants.

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