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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorFirst Hospital of China Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Trial groupExperimental treatment 2 interventions
Group B: Control groupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Complete clearance rate of warts within 6 months

The complete clearance rate was defined as the proportion of patients with lesions that completely disappeared within 6 months of completing all treatments.

Time frame
6 months after the first time of treatment.
2

Recurrence rate of warts

Recurrence was the proportion of patients with recurrence of lesions at the cured lesion site within 6 and 12 months after treatment.

Time frame
recurrence was the proportion of patients with reappearance of lesions at previously cleared sites within 6,12 months after treatment.
3

Complete clearance rate of warts within 3 months

The complete clearance rate was defined as the proportion of patients with lesions that completely disappeared within 3 months of completing all treatments.

Time frame
3 months after the first time of treatment.
4

HPV genotyping

Collect the tissue sample from the wart for HPV gene testing.

Time frame
Pre-treatment and 3,6 months after the first time of treatment

Secondary outcomes

1

Changes in the size and number of warts at different points in time

Changes in the size and number of warts at different time points (1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 24 weeks)

Time frame
At 1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 24 weeks follow-up
2

Curative effect of different types of warts

The cure of different types of warts (common warts, plantar warts, condyloma acuminatum) was followed up at 6 months.

Time frame
followed up at 6 months.
3

Occurrence of adverse events

occurrence of adverse events (short - and long-term adverse reactions) (e.g. blisters, erythema, nail changes, ulcers/scars, hyperpigmentation, hypopigmentation, erosion)

Time frame
During treatment and follow-up
4

Treatment-related pain intensity

Pain assessed by Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain)

Time frame
During each treatment session (Day 1, 2, 3, 10, 11, 18, 19, 26, ....180)

Other outcomes

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