RecruitingNot ApplicableNCT07534865

Hyperthermia Combined With Hydrogen Peroxide Microneedle Patch for Viral Warts

A Randomized, Parallel-Group, Controlled, Assessor-Blinded Clinical Trial of Hyperthermia Combined With Hydrogen Peroxide Microneedle Patch for Viral Warts

Sponsor

First Hospital of China Medical University

Enrollment

210 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Warts

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. Significant progress has been made in the application of hyperthermia for viral skin diseases. Clinically, the addition of hydrogen peroxide solution can enhance the efficacy of hyperthermia in treating HPV infection. As a common transdermal drug delivery method, microneedles can increase drug penetration and thereby further improve treatment outcomes. Based on these findings, this study aims to explore an adjunctive approach to hyperthermia for treating viral warts to further enhance therapeutic efficacy. This study employs a randomized, parallel-group, assessor-blinded design. Participants will be randomly assigned to three groups: hyperthermia alone, hyperthermia combined with microneedle patch (loaded with 0.9% saline), and hyperthermia combined with hydrogen peroxide microneedle patch (experimental group). An adaptive design will be adopted. The sample size is estimated at 70 participants per group, accounting for a potential 20% dropout rate. Interim analyses will be conducted during follow-up, and enrollment will be stopped when a positive result is reached for the primary efficacy endpoint (cure rate), at which point the sample size will be adjusted accordingly.

Eligibility

Min Age: 6 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 0.9 % saline, a drug called 3% hydrogen peroxide solution, and others for people with warts. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG3% hydrogen peroxide solution

Dressing: Like the Local Hyperthermia Group, use a microneedle patch loaded with 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.

DRUG0.9 % saline

Dressing: Like the Local Hyperthermia Group, use a microneedle patch loaded with 0.9% saline. 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.

DEVICEHyperthermia at 44℃

The infrared hyperthermia device was used as follows: based on the thermal tolerance of different body surface areas, the surface temperature was set to 44 °C ± 1 °C. The lesion was disinfected with alcohol. After the skin had dried, the patient's most painful or largest wart was selected as the target lesion and treated with 44 °C hyperthermia. The treatment was administered for three consecutive days (sessions), each lasting 30 minutes. After an interval of 7-10 days, the same target lesion received two consecutive days (sessions) of treatment, followed by one session every 7-10 days thereafter. For patients with multiple lesions, only one target lesion was treated using the above protocol, while the remaining lesions received no intervention.

DEVICEMicroneedle patch

Purpose: To facilitate drug loading. Instructions:Add an appropriate amount of 3% hydrogen peroxide solution or 0.9% sodium chloride solution into the corresponding chamber. Apply the microneedle patch to the wart and secure it with tape. Press the raised part of the aluminum film sequentially with fingers until the chamber fully collapses and makes contact with the skin. After one hour of contact, dispose of the patch in a medical waste container.