Local Hyperthermia Combined With Topical 3% Hydrogen Peroxide for Refractory Viral Warts

• An infrared hyperthermia device (Device): (Patent No: ZL 200820231952.4, Model: YY-WRY-V01, Liaoning Yanyang Medical Instrument Co., Ltd., China) An infrared hyperthermia device was used to apply local hyperthermia at 44°C to the target warts(largest and most severe warts).The device includes a heating source, an infrared temperature monitor, an adjusting arm, a control circuit for temperature stabilization, and a display. It uses a tungsten-halogen lamp (wavelength: 760-2300 nm, peak at 1200 nm) to maintain the temperature of a 0.5*0.5 cm skin area within ±0.1°C using a non-contact infrared feedback system.Hyperthermia: Conduct 44-degree Celsius, 30-minute sessions. Do it daily for the first 3 days, then 2 sessions every 7 days for 24 weeks.
• Hydrogen Peroxide 3 % Topical Solution (Drug): Dressing: Dress with a cotton ball soaked in 3% hydrogen peroxide one hour prior to each hyperthermia session. Local Hyperthermia treats the target warts(largest and most severe warts), while medication addresses all warts.
• Normal Saline (NS) (Drug): The control group used normal saline as the placebo for wet compress, and the hyperthermia treatment was the same as that of the trial group.

Primary outcomes

• Complete clearance rate of warts within 6 months [6 months after the first time of treatment.]: The complete clearance rate was defined as the proportion of patients with lesions that completely disappeared within 6 months of completing all treatments.
• Recurrence rate of warts [recurrence was the proportion of patients with reappearance of lesions at previously cleared sites within 6,12 months after treatment.]: Recurrence was the proportion of patients with recurrence of lesions at the cured lesion site within 6 and 12 months after treatment.
• Complete clearance rate of warts within 3 months [3 months after the first time of treatment.]: The complete clearance rate was defined as the proportion of patients with lesions that completely disappeared within 3 months of completing all treatments.
• HPV genotyping [Pre-treatment and 3,6 months after the first time of treatment]: Collect the tissue sample from the wart for HPV gene testing.
• Pathogenic Gene Screening Analysis [Pre-treatment]: Collecting patient blood samples for pathogenic gene screening
• Immune-related cytokines [Pre-treatment and 3,6 months after the first time of treatment]: Collecting the patient's blood samples to test immune-related cytokines

Secondary outcomes

• Changes in the size and number of warts at different points in time [At 1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 24 weeks follow-up]: Changes in the size and number of warts at different time points (1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 24 weeks)
• Curative effect of different types of warts [followed up at 6 months.]: The cure of different types of warts (common warts, plantar warts, condyloma acuminatum) was followed up at 6 months.
• Occurrence of adverse events [During treatment and follow-up]: occurrence of adverse events (short - and long-term adverse reactions) (e.g. blisters, erythema, nail changes, ulcers/scars, hyperpigmentation, hypopigmentation, erosion)
• Treatment-related pain intensity [During each treatment session (Day 1, 2, 3, 10, 11, 18, 19, 26, ....180)]: Pain assessed by Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain)
• Patient satisfaction score [At 6-month follow-up]: Self-reported satisfaction on a 5-point Likert scale (0=very dissatisfied, 5=very satisfied)

Sex: All

Inclusion Criteria:

\- 1: Patients with a disease course of ≥2 years who have failed to respond to ≥2 treatment methods (such as topical ointments, cryotherapy, laser therapy, etc.)

2: The subject or their legal guardian is able to understand and sign the informed consent form/agree to participate in the study.

Exclusion Criteria:

* 1: The subject or their legal guardian is unable to understand and refuses to sign the informed consent form / refuses to participate in the study

  2: Individuals allergic to local hyperthermia or hydrogen peroxide;

  3: Subjects with tumors or other serious diseases are unable to complete this clinical study;

  4: Due to personal or other objective reasons, it is not possible to ensure timely treatment and follow-up.