Hyperthermia Combined With Hydrogen Peroxide Microneedle Patch for Viral Warts

NCT07534865 | Recruiting

• 1 other identifier: 【2025】770
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Warts

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 (4)

• Changes in the size and number of warts at different points in time

  At months 1, 3, and 6

• 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)

• Time to first wart clearance

  At months 1, 3, and 6

Study Arms (3)

Hyperthermia at 44°C

EXPERIMENTAL

Sterile cotton soaked in normal saline was applied to cover each wart, followed by occlusion with plastic film for one hour, once daily, for six consecutive weeks. One wart was selected to receive 44 °C hyperthermia for 30 minutes per session: three consecutive sessions in the first week, two sessions in the second week, and two sessions in the third week. Hyperthermia was administered immediately after occlusion, during which the wart was rinsed with normal saline and gently dried with a sterile cotton swab before the start of hyperthermia.

Drug: 0.9 % saline; Device: Hyperthermia at 44℃

Hyperthermia combined with microneedle patch (loaded with 0.9% saline)

EXPERIMENTAL

One wart was selected to receive 44 °C hyperthermia for 30 minutes per session: three consecutive sessions in the first week, two sessions in the second week, and two sessions in the third week. A microneedle patch loaded with 0.9% saline was applied to the target lesion daily for one hour per day, for a total of six weeks.

Drug: 0.9 % saline; Device: Hyperthermia at 44℃; Device: Microneedle patch

Hyperthermia combined with hydrogen peroxide microneedle patch

EXPERIMENTAL

One wart was selected to receive 44 °C hyperthermia for 30 minutes per session: three consecutive sessions in the first week, two sessions in the second week, and two sessions in the third week. A hydrogen peroxide microneedle patch was applied to the target lesion daily for one hour per day, for a total of six weeks.

Drug: 3% hydrogen peroxide solution; Device: Hyperthermia at 44℃; Device: Microneedle patch

Interventions

3% hydrogen peroxide solution DRUG

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.

Hyperthermia combined with hydrogen peroxide microneedle patch

0.9 % saline DRUG

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.

Hyperthermia at 44°C; Hyperthermia combined with microneedle patch (loaded with 0.9% saline)

Hyperthermia at 44℃ DEVICE

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.

Hyperthermia at 44°C; Hyperthermia combined with hydrogen peroxide microneedle patch; Hyperthermia combined with microneedle patch (loaded with 0.9% saline)

Microneedle patch DEVICE

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.

Hyperthermia combined with hydrogen peroxide microneedle patch; Hyperthermia combined with microneedle patch (loaded with 0.9% saline)

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 6-65 years, male or female;
• Clinically diagnosed with common warts, palmar/plantar/digital warts (≥1 lesion), with a Physician's Wart Assessment score ≥2 (0: no visible wart, no further treatment required; 1: visible wart, diameter \<3 mm; 2: single wart diameter ≥3 mm and \<6 mm; 3: single wart diameter ≥6 mm);
• The subject or legal guardian is able to understand and sign the informed consent form and agrees to participate in the study.

You may not qualify if:

• Subjects presenting with atypical warts clinically;
• Subjects with immune dysfunction or autoimmune diseases;
• Pregnant or breastfeeding women;
• Subjects who have received human papillomavirus (HPV) vaccination within the past 6 months;
• Subjects who have undergone the following systemic treatments within the specified time frames: immunomodulators/immunosuppressants (e.g., etanercept), within 4 months; corticosteroids (inhaled and intranasal use permitted), within 1 month;
• Subjects who have received the following treatments on or around the warts within the specified time frames: laser or other photochemical therapies (intense pulsed light, photodynamic therapy), within 3 months; immunotherapy (candida antigen), within 4 months; cryotherapy with liquid nitrogen, within 2 months; hydrogen peroxide, within 3 months; antimetabolite therapy (5-fluorouracil), within 2 months; retinoids, within 3 months;
• Subjects with a history of the following diseases prior to enrollment: skin malignancy within the past 6 months, premalignant skin conditions (actinic keratosis) within the past 6 months, or currently in the acute progressive phase of skin or systemic diseases (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.) or presenting with conditions (such as sunburn, open wounds) that may increase the risk of participation or interfere with evaluation;
• Subjects with diseases affecting skin healing, such as diabetes mellitus, vitamin A deficiency, etc.;
• Subjects with cold-sensitive conditions such as cryoglobulinemia or cold urticaria that may lead to abnormal observation results;
• Subjects with severe dysfunction of the heart, lung, liver, kidney, hematopoietic system, or other vital organs.

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Sites (1)

Infrared Hyperthermia Device

Shenyang, China

RECRUITING

MeSH Terms

Conditions

Warts

Interventions

Sodium Chloride

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Hao Guo

CONTACT

+86 13840365892; guohao27@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)