Study of Hyperthermia Combined With Hydrogen Peroxide Microneedle Patch to Treat Viral Warts in Patients Aged 6 to 65

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 bodys 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.

Hyperthermia Combined With Hydrogen Peroxide Microneedle Patch for Viral Warts