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NCT Number: NCT07565350

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Infrared hyperthermia device (Patent No: ZL 200820231952.4, Model: YY-WRY-V01, Liaoning Yanyang Medical Instrument Co., Ltd., China), Shenyang, Liaoning, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. Complete clearance rate of warts within 6 months

    Time frame: 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.

  2. 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.

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

  3. Complete clearance rate of warts within 3 months

    Time frame: 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.

  4. HPV genotyping

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

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

  5. Pathogenic Gene Screening Analysis

    Time frame: Pre-treatment

    Collecting patient blood samples for pathogenic gene screening

  6. Immune-related cytokines

    Time frame: 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

  1. 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

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

  2. Curative effect of different types of warts

    Time frame: followed up at 6 months.

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

  3. Occurrence of adverse events

    Time frame: 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)

  4. Treatment-related pain intensity

    Time frame: 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)

  5. Patient satisfaction score

    Time frame: At 6-month follow-up

    Self-reported satisfaction on a 5-point Likert scale (0=very dissatisfied, 5=very satisfied)

Study contacts

Contact information is provided by the study sponsor or research team.

Xinghua Gao

CONTACT

[email protected]

024-83282524

Sponsors and collaborators

Lead sponsor

First Hospital of China Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 4, 2026
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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