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Randomized Single-blind Parallel Controlled Clinical Trial of Hyperthermia Combined With Topical 3% Hydrogen Peroxide for Refractory Viral Warts

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

1. Background of the Problem Viral warts result from infection of the skin or mucous membranes by human papillomavirus (HPV). Some patients develop refractory cases due to abnormal immune function, persistent viral presence, or recurrent warts. The clinical challenge in treating refractory viral warts lies in the limited effectiveness of single therapeutic approaches, high recurrence rates, and the fact that a significant proportion of patients are infected with high-risk or special HPV subtypes. These factors necessitate combined multi-modal treatments and genetic etiological screening. 2. Current Treatment Status Thermotherapy (44°C ± 2°C, 30 minutes per session): Studies have demonstrated that it can stimulate the activation of local immune cells (such as Langerhans cells), thereby enhancing antiviral immune responses. Hydrogen peroxide: It possesses antibacterial properties and promotes tissue repair. In keratinocytes, it can induce thermally induced pyroptosis, thereby enhancing the efficacy of antiviral treatment. 3. HPV genotyping Refractory viral warts are often associated with infection by specific high-risk or low-risk HPV subtypes (e.g., HPV 16, 18, 2, 4, etc.). HPV genotype is closely linked to treatment outcomes and recurrence rates. 4. Relevant pathogenic gene screening This involves exploring intrinsic patient susceptibility, such as genetic polymorphisms related to immune function (e.g., HLA typing or Toll-like receptor-related genes). It also includes screening for rare gene mutations, such as mutations in the GATA2, IL2RG, and DOCK8 genes, which lead to impaired viral clearance and a propensity to develop multiple viral warts.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• \- 1: Patients with a disease course of ≥2 years who have failed to respond to ≥2 treatment methods (such as topical ointments, cryotherapy, laser therapy, etc.)

• 2: The subject or their legal guardian is able to understand and sign the informed consent form/agree to participate in the study.

Locations
Other Locations
China
Infrared hyperthermia device (Patent No: ZL 200820231952.4, Model: YY-WRY-V01, Liaoning Yanyang Medical Instrument Co., Ltd., China)
RECRUITING
Shenyang
Infrared hyperthermia device (Patent No: ZL 200820231952.4, Model: YY-WRY-V01, Liaoning Yanyang Medical Instrument Co., Ltd., China)
RECRUITING
Shenyang
Contact Information
Primary
Xinghua Gao
gaobarry@hotmail.com
024-83282524
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 80
Treatments
Experimental: Trial group
Local hyperthermia combined with hydrogen peroxide
Placebo_comparator: Control group
Local hyperthermia combined with normal saline
Related Therapeutic Areas
Sponsors
Leads: First Hospital of China Medical University

This content was sourced from clinicaltrials.gov