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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Infrared Hyperthermia Device
  Shenyang, China Recruiting

Study contacts

• Study coordinator: Hao Guo
• Email: guohao27@126.com
• Phone: +86 13840365892

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using Candida antigen and a bivalent HPV vaccine to clear multiple common warts

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.