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

Official title

Randomized Single-blind Parallel Controlled Clinical Trial of Hyperthermia Combined With Topical 3% Hydrogen Peroxide for Refractory Viral Warts

Overview

1. Background of the Problem Viral warts result from infection of the skin or mucous membranes by human papillomavirus (HPV). Some patients develop refractory cases due to abnormal immune function, persistent viral presence, or recurrent warts. The clinical challenge in treating refractory viral warts lies in the limited effectiveness of single therapeutic approaches, high recurrence rates, and the fact that a significant proportion of patients are infected with high-risk or special HPV subtypes. These factors necessitate combined multi-modal treatments and genetic etiological screening. 2. Current Treatment Status Thermotherapy (44°C ± 2°C, 30 minutes per session): Studies have demonstrated that it can stimulate the activation of local immune cells (such as Langerhans cells), thereby enhancing antiviral immune responses. Hydrogen peroxide: It possesses antibacterial properties and promotes tissue repair. In keratinocytes, it can induce thermally induced pyroptosis, thereby enhancing the efficacy of antiviral treatment. 3. HPV genotyping Refractory viral warts are often associated with infection by specific high-risk or low-risk HPV subtypes (e.g., HPV 16, 18, 2, 4, etc.). HPV genotype is closely linked to treatment outcomes and recurrence rates. 4. Relevant pathogenic gene screening This involves exploring intrinsic patient susceptibility, such as genetic polymorphisms related to immune function (e.g., HLA typing or Toll-like receptor-related genes). It also includes screening for rare gene mutations, such as mutations in the GATA2, IL2RG, and DOCK8 genes, which lead to impaired viral clearance and a propensity to develop multiple viral warts.

Interventions

• Device An infrared hyperthermia 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.
• Drug Hydrogen Peroxide 3 % Topical Solution
  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.
• Drug Normal Saline (NS)
  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 outcome measures

• Complete clearance rate of warts within 6 months [Time frame: 6 months after the first time of treatment.]
• Recurrence rate of warts [Time frame: recurrence was the proportion of patients with reappearance of lesions at previously cleared sites within 6,12 months after treatment.]
• Complete clearance rate of warts within 3 months [Time frame: 3 months after the first time of treatment.]
• HPV genotyping [Time frame: Pre-treatment and 3,6 months after the first time of treatment]
• Pathogenic Gene Screening Analysis [Time frame: Pre-treatment]
• Immune-related cytokines [Time frame: Pre-treatment and 3,6 months after the first time of treatment]

Secondary outcome measures (5)

• Changes in the size and number of warts at different points in time [Time frame: At 1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 24 weeks follow-up]
• Curative effect of different types of warts [Time frame: followed up at 6 months.]
• Occurrence of adverse events [Time frame: During treatment and follow-up]
• Treatment-related pain intensity [Time frame: During each treatment session (Day 1, 2, 3, 10, 11, 18, 19, 26, ....180)]
• Patient satisfaction score [Time frame: At 6-month follow-up]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 2 centers

• Infrared hyperthermia device (Patent No: ZL 200820231952.4, Model: YY-WRY-V01, Liaoning Ya — Shenyang
• Infrared hyperthermia device (Patent No: ZL 200820231952.4, Model: YY-WRY-V01, Liaoning Ya — Shenyang

Identifiers

NCT: NCT07565350 · 2025-641-2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗