Randomized Single-blind Parallel Controlled Clinical Trial of Hyperthermia Combined With Topical 3% Hydrogen Peroxide for Refractory Viral Warts
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Complete clearance rate of warts within 6 months
研究概览
简要总结
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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.
排除标准
- •1: The subject or their legal guardian is unable to understand and refuses to sign the informed consent form / refuses to participate in the study
- •2: Individuals allergic to local hyperthermia or hydrogen peroxide;
- •3: Subjects with tumors or other serious diseases are unable to complete this clinical study;
- •4: Due to personal or other objective reasons, it is not possible to ensure timely treatment and follow-up.
研究组 & 干预措施
Trial group
Local hyperthermia combined with hydrogen peroxide
干预措施: An infrared hyperthermia device (Device)
Trial group
Local hyperthermia combined with hydrogen peroxide
干预措施: Hydrogen Peroxide 3 % Topical Solution (Drug)
Control group
Local hyperthermia combined with normal saline
干预措施: An infrared hyperthermia device (Device)
Control group
Local hyperthermia combined with normal saline
干预措施: Normal Saline (NS) (Drug)
结局指标
主要结局
Complete clearance rate of warts within 6 months
时间窗: 6 months after the first time of treatment.
The complete clearance rate was defined as the proportion of patients with lesions that completely disappeared within 6 months of completing all treatments.
Recurrence rate of warts
时间窗: recurrence was the proportion of patients with reappearance of lesions at previously cleared sites within 6,12 months after treatment.
Recurrence was the proportion of patients with recurrence of lesions at the cured lesion site within 6 and 12 months after treatment.
Complete clearance rate of warts within 3 months
时间窗: 3 months after the first time of treatment.
The complete clearance rate was defined as the proportion of patients with lesions that completely disappeared within 3 months of completing all treatments.
HPV genotyping
时间窗: Pre-treatment and 3,6 months after the first time of treatment
Collect the tissue sample from the wart for HPV gene testing.
Pathogenic Gene Screening Analysis
时间窗: Pre-treatment
Collecting patient blood samples for pathogenic gene screening
Immune-related cytokines
时间窗: Pre-treatment and 3,6 months after the first time of treatment
Collecting the patient's blood samples to test immune-related cytokines
次要结局
- Changes in the size and number of warts at different points in time(At 1 week, 2 weeks, 3 weeks, 4 weeks, 12 weeks, 24 weeks follow-up)
- Curative effect of different types of warts(followed up at 6 months.)
- Occurrence of adverse events(During treatment and follow-up)
- Treatment-related pain intensity(During each treatment session (Day 1, 2, 3, 10, 11, 18, 19, 26, ....180))
- Patient satisfaction score(At 6-month follow-up)
研究者
Gao Xinghua
Professor
First Hospital of China Medical University
