ClinicalTrials.gg
RecruitingNCT07565350Updated May 4, 2026

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

An interventional study of An infrared hyperthermia device and Hydrogen Peroxide 3 % Topical Solution in Refactory Warts, sponsored by First Hospital of China Medical University. Recruiting at 2 sites in China. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by First Hospital of China Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2025, registered Apr 2026).
  • Started Oct 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Sex
All
01

Study summary

  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.
02

Conditions studied

  • Refactory Warts

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Keywords

  • Thermotherapy; Hydrogen peroxide; Refractory viral warts
03

In context

Hyperthermia

256 studies on the registry are indexed under Hyperthermia; 73 are open to participants now.

This study's planned enrollment of 80 is above the median of 40 across 232 interventional studies indexed under Hyperthermia.

Browse Hyperthermia studies →

Lead sponsor

First Hospital of China Medical University is the lead sponsor of 62 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form/agree to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • 1: The subject or their legal guardian is unable to understand and refuses to sign the 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Trial group

    Local hyperthermia combined with hydrogen peroxide

    Device: An infrared hyperthermia device · Drug: Hydrogen Peroxide 3 % Topical Solution

  • Placebo comparator
    Control group

    Local hyperthermia combined with normal saline

    Device: An infrared hyperthermia device · Drug: Normal Saline (NS)

Interventions

  • DeviceAn 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\*0.5 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.

  • 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.

  • DrugNormal 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.

06

What researchers measure

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

  5. Pathogenic Gene Screening Analysis

    Collecting patient blood samples for pathogenic gene screening

    Time frame: Pre-treatment

  6. Immune-related cytokines

    Collecting the patient's blood samples to test immune-related cytokines

    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)

  5. Patient satisfaction score

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

    Time frame: At 6-month follow-up

07

Study locations

2 of 2 sites recruiting
  • Infrared hyperthermia device (Patent No: ZL 200820231952.4, Model: YY-WRY-V01, Liaoning Yanyang Medical Instrument Co., Ltd., China)
    Shenyang, Liaoning 110001, China
    Recruiting
    • · Contact+86 13792269768
  • Infrared hyperthermia device (Patent No: ZL 200820231952.4, Model: YY-WRY-V01, Liaoning Yanyang Medical Instrument Co., Ltd., China)
    Shenyang, Liaoning, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07565350
Lead sponsor
First Hospital of China Medical University
Responsible party
Gao Xinghua (Professor, First Hospital of China Medical University) — Principal investigator
First posted
May 4, 2026
Start date
Oct 1, 2025
Primary completion
Oct 1, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
May 4, 2026

Study contacts

Xinghua Gao
Contact
gaobarry@hotmail.com
024-83282524

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Hydrogen Peroxide

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