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

NCT07565350 | Recruiting

• 1 other identifier: 2025-641-2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

1. 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. 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.
3. 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. 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.

Conditions

Refactory Warts

Keywords

Thermotherapy; Hydrogen peroxide; Refractory viral warts

Outcome Measures

Primary Outcomes (6)

• 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.

  6 months after the first time of treatment.

• 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.

  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

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

  3 months after the first time of treatment.

• HPV genotyping

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

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

• Pathogenic Gene Screening Analysis

  Collecting patient blood samples for pathogenic gene screening

  Pre-treatment

• Immune-related cytokines

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

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

Secondary Outcomes (5)

• 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

• Curative effect of different types of warts

  followed up at 6 months.

• Occurrence of adverse events

  During treatment and follow-up

• Treatment-related pain intensity

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

• Patient satisfaction score

  At 6-month follow-up

Study Arms (2)

Trial group

EXPERIMENTAL

Local hyperthermia combined with hydrogen peroxide

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

Control group

PLACEBO COMPARATOR

Local hyperthermia combined with normal saline

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

Interventions

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.

Control group; Trial group

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.

Trial group

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.

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• : The subject or their legal guardian is unable to understand and refuses to sign the informed consent form / refuses to participate in the study
• : Individuals allergic to local hyperthermia or hydrogen peroxide;
• : Subjects with tumors or other serious diseases are unable to complete this clinical study;
• : Due to personal or other objective reasons, it is not possible to ensure timely treatment and follow-up.

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Sites (2)

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

Shenyang, Liaoning, 110001, China

RECRUITING

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

Shenyang, Liaoning, China

RECRUITING

MeSH Terms

Conditions

Hyperthermia; Warts

Interventions

Hydrogen Peroxide; Solutions; Saline Solution

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries; Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Peroxides; Oxides; Anions; Ions; Electrolytes; Inorganic Chemicals; Reactive Oxygen Species; Free Radicals; Oxygen Compounds; Organic Chemicals; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions

Central Study Contacts

Xinghua Gao

CONTACT

024-83282524; gaobarry@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: May 4, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 4, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)