Randomized Controlled Clinical Trial of Hyperthermia and Hydrogen Peroxide 3% in the Treatment of Cutaneous Warts

NCT06812065 | Recruiting

• 1 other identifier: GH20210930
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

Hyperthermia treatment (hyperthermia) refers to treating diseases with temperature (39-45 ° C) beyond normal body temperature,. It has been reported that local warming at 44 ° C is able to effectively mobilize the body's immunity and clear HPV infected lesions, such as condyloma acuminatum and verruca vulgaris, etc. Hydrogen peroxide (H2O2) is a commonly used disinfectant for skin debridement. It has been reported that high concentration of H2O2 (45% H2O2) is effective in the treatment of warts vulgaris, however, high concentration of H2O2 will cause more local pain, itching and burning sensation. 3% hydrogen peroxide is commonly used as skin debridement disinfectant. The purpose of the study is to evaluate the efficacy and safety of 44℃ hyperthermia combined with 3% hydrogen peroxide in treating verruca virus.

Conditions

Warts

Keywords

hyperthermia; Warts; Hydrogen Peroxide

Outcome Measures

Primary Outcomes (3)

• Complete clearance rate of warts

  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.

• Time to complete clearance

  Median duration from first treatment to complete resolution (days)

  6 months after the first time of treatment.

• Recurrence rate of warts

  Complete clearance was defined as the proportion of patients with complete disappearance of lesions within 6 months of completion of all treatments, and 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 months after 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)

• Patient satisfaction score

  At 6-month follow-up

Study Arms (3)

Local Hyperthermia at 44℃

EXPERIMENTAL

As an experimental arm.

Device: Local Hyperthermia at 44℃

Local 3%H2O2 treatment

EXPERIMENTAL

As an experimental arm

Drug: Hydrogen Peroxide 3 % Topical Solution

3%H2O2 for 1 hour, then local hyperthermia at 44℃ for 30 minutes

EXPERIMENTAL

Undergo the hyperthermia treatment of the Local Hyperthermia Group and the dressing treatment of the 3% Hydrogen Peroxide Group. Apply the 3% hydrogen peroxide dressing 1 hour before each hyperthermia session. Local Hyperthermia treats the target warts(largest and most severe warts), while medication addresses all warts.

Drug: Hydrogen Peroxide 3 % Topical Solution; Device: Local Hyperthermia at 44℃

Interventions

Hydrogen Peroxide 3 % Topical Solution DRUG

Dressing: Like the Local Hyperthermia Group, use a cotton ball soaked in 3% hydrogen peroxide. Irradiation: For seven sessions in three weeks, use simulated infrared light (without heat) with the same frequency as the Local Hyperthermia Group. Local Hyperthermia treats the target warts(largest and most severe warts), while medication addresses all warts.

3%H2O2 for 1 hour, then local hyperthermia at 44℃ for 30 minutes; Local 3%H2O2 treatment

Local Hyperthermia at 44℃ 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 largest wart. 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 3 weeks, for a total of 7 sessions. Dressing: Apply a cotton ball soaked in 0.9% saline to the warts, wrap it with plastic film for 1 hour, and do this once a day for 6 weeks. Local Hyperthermia treats the target warts(largest and most severe warts), while medication addresses all warts.

3%H2O2 for 1 hour, then local hyperthermia at 44℃ for 30 minutes; Local Hyperthermia at 44℃

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Sites (2)

Guo Hao

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, 110001, China

RECRUITING

MeSH Terms

Conditions

Warts; Hyperthermia

Interventions

Hydrogen Peroxide; Solutions

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Xinghua Gao

  First Hospital of China Medical University

  STUDY DIRECTOR

Central Study Contacts

Hao Guo

CONTACT

+86 13840365892; guohao27@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking Description: * Participants blinded to treatment allocation through: 1. Identical-appearing placebo devices with sham light emission 2. Opaque containers for topical solutions (H2O2 vs saline) 3. Separate treatment rooms per study arm * Outcome assessors blinded to group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 6, 2025
• Study Start: December 7, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)