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

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.

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.