Actively Recruiting
A Randomized, Controlled, Assessor-Blinded Trial of Hyperthermia With Hydrogen Peroxide Microneedle Patch for Viral Warts
Led by First Hospital of China Medical University · Updated on 2026-04-16
210
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of hyperthermia treatment combined with microneedle patches to improve the treatment of viral warts. Hyperthermia involves raising the temperature of the skin to about 44 6C, which may help activate the body's immune response to clear HPV-infected lesions. This study compares three groups: hyperthermia alone, hyperthermia with a microneedle patch loaded with saline, and hyperthermia with a hydrogen peroxide microneedle patch to enhance treatment effects. Participants will be randomly assigned to receive one of the three treatments. Hyperthermia is applied to a selected wart for 30 minutes per session, with three sessions in the first week, two in the second, and two in the third week. The microneedle patches, either loaded with saline or hydrogen peroxide, are applied daily for one hour over six weeks. The study follows a randomized, parallel-group, assessor-blinded design with adaptive sample size adjustments based on interim results. During the study, participants will undergo treatment sessions and follow-up visits to monitor wart clearance and recurrence. Researchers will assess complete wart clearance rates, time to clearance, recurrence within six months, changes in wart size and number, pain during treatment, and any adverse events. The entire evaluation period includes treatment and six months of follow-up to gather comprehensive safety and efficacy data.
CONDITIONS
Brief Title
Hyperthermia Combined With Hydrogen Peroxide Microneedle Patch for Viral Warts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 and 65 years, male or female
- Clinically diagnosed with common warts on hands, feet, or fingers, with at least one lesion
- Physician's Wart Assessment score of 2 or higher
- Ability to understand and sign informed consent and agree to participate
You will not qualify if you...
- Presence of atypical warts
- Immune dysfunction or autoimmune diseases
- Pregnancy or breastfeeding
- Received HPV vaccination within the past 6 months
- Recent use of systemic immunomodulators, immunosuppressants, or corticosteroids within specified time frames
- Recent wart treatments such as laser therapy, immunotherapy, cryotherapy, hydrogen peroxide, antimetabolites, or retinoids within specified time frames
- History of skin malignancy or premalignant conditions within past 6 months
- Acute or progressive skin or systemic diseases, or skin conditions that increase risk or interfere with evaluation
- Diseases affecting skin healing like diabetes or vitamin A deficiency
- Cold-sensitive conditions such as cryoglobulinemia or cold urticaria
- Severe dysfunction of heart, lung, liver, kidney, blood, or other vital organs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive hyperthermia treatment at 44°C on one selected wart with multiple sessions over three weeks. Depending on the group, participants also apply a microneedle patch loaded with either hydrogen peroxide or saline daily for six weeks.
Multiple visits for hyperthermia sessions during the first three weeks and daily patch application for six weeks
Duration - Up to 6 months
Participants are monitored for wart clearance, recurrence, and any adverse events for up to 6 months after treatment.
Visits at months 1, 3, and 6 for assessment
Trial Site Locations
Total: 1 location
1
Infrared Hyperthermia Device
Shenyang, China
Actively Recruiting
Research Team
H
Hao Guo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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