Heat combined with a hydrogen peroxide microneedle patch for common warts.

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

This test will see if applying local heat at 44°C together with a microneedle patch that delivers 3% hydrogen peroxide clears common hand and foot warts in people aged 6 to 65.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 6 Years to 65 Years
• Sex: All
• Sponsor: First Hospital of China Medical University (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Shenyang)
• Trial ID: NCT07534865 on ClinicalTrials.gov

What this trial studies

This randomized, parallel-group, assessor-blinded trial compares hyperthermia alone, hyperthermia plus a microneedle patch loaded with 3% hydrogen peroxide, and hyperthermia plus a microneedle patch with saline as a control. Treatments use an infrared device to warm lesions to 44°C and apply microneedles to increase transdermal delivery. Participants aged 6–65 with one or more common palmar/plantar/digital warts are followed for clinical wart clearance and safety. Outcomes include changes in wart size and a physician's wart assessment score along with recorded adverse events.

Who should consider this trial

Good fit: Ideal candidates are people aged 6–65 with one or more common palmar, plantar, or digital warts of at least 3 mm diameter who can consent and attend in-person treatments.

Not a fit: Patients with atypical warts, immune dysfunction or autoimmune disease, recent HPV vaccination or recent systemic immunosuppression, and pregnant or breastfeeding women are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If effective, the combination could produce faster or higher rates of wart clearance than heat alone using a minimally invasive, office-based procedure.

How similar studies have performed: Previous reports suggest local hyperthermia and topical hydrogen peroxide can help clear HPV-related skin lesions, but combining hyperthermia with a hydrogen-peroxide microneedle patch is a novel approach with limited prior data.

Eligibility criteria

Inclusion Criteria:

1. Age 6-65 years, male or female;
2. 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);
3. The subject or legal guardian is able to understand and sign the informed consent form and agrees to participate in the study.

Exclusion Criteria:

1. Subjects presenting with atypical warts clinically;
2. Subjects with immune dysfunction or autoimmune diseases;
3. Pregnant or breastfeeding women;
4. Subjects who have received human papillomavirus (HPV) vaccination within the past 6 months;
5. 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;
6. 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;
7. 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;
8. Subjects with diseases affecting skin healing, such as diabetes mellitus, vitamin A deficiency, etc.;
9. Subjects with cold-sensitive conditions such as cryoglobulinemia or cold urticaria that may lead to abnormal observation results;
10. Subjects with severe dysfunction of the heart, lung, liver, kidney, hematopoietic system, or other vital organs.

Where this trial is running

Shenyang

• Infrared Hyperthermia Device — Shenyang, China (Recruiting)

Study contacts

• Study coordinator: Hao Guo

Conditions Warts