Actively Recruiting

Phase Not Applicable
All Genders
ID06827938

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

Led by First Hospital of China Medical University · Updated on 2025-08-14

400

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effectiveness and safety of hyperthermia treatment for viral warts in special populations, including pregnant women, children, patients with autoimmune diseases, diabetes, and those on immunosuppressants after organ transplantation. Hyperthermia, a treatment using temperatures above normal body temperature, has shown promise in early studies by activating the body's immune response to remove HPV infection lesions. Prior research by this group indicated a 45-55% cure rate with hyperthermia, with benefits like no trauma, low recurrence, and good tolerance, leading to inclusion in medical guidelines and device registration for national promotion. The study uses an infrared hyperthermia device set at 44±1°C applied to lesions. Treatment involves three consecutive days of 30-minute sessions, followed by a break of 7-10 days, then two consecutive days of treatment, and subsequent sessions every 7-10 days. Lesion changes are assessed after 15 treatments to monitor the response to therapy. Participants will be monitored for cure and recurrence rates at three and six months, alongside rates of any adverse reactions. The study is conducted in multiple centers with real-world settings, focusing on this special population with viral warts. The total treatment and follow-up duration allow for assessing both short-term and longer-term outcomes of hyperthermia therapy for wart removal.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 currently treated with immunosuppressants
  • Children with viral warts
  • Ability of the subject or legal guardian to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Presence of tumor or other serious disease preventing completion of the study
  • Inability to guarantee timely treatment and follow-up due to personal or other objective reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - Duration of treatment with 15 sessions over several weeks

Participants receive infrared hyperthermia treatment using a device at 44±1℃. The treatment is applied for 3 consecutive days with sessions each day lasting 30 minutes, followed by 2 days of treatment after 7 to 10 days, and then repeated every 7 to 10 days for a total of 15 treatments. Lesion changes are assessed throughout the treatment period.

Multiple visits corresponding to treatment sessions

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China, 110001

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Research Team

W

Wei Huo, Doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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