Rrandomized Controlled Clinical Trial Named Mild Local Hyperthermia and Hydrogen Peroxide Treat Multiple Warts by Targeting a Single Lesion.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Complete clearance rate of warts
研究概览
简要总结
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.
Hydrogen peroxide (H2O2) is a commonly used disinfectant for skin debridement. It has been reported that high concentration of H2O2 (45% H2O2) is effective in the treatment of warts vulgaris, however, high concentration of H2O2 will cause more local pain, itching and burning sensation. 3% hydrogen peroxide is commonly used as skin debridement disinfectant.
The purpose of the study is to evaluate the efficacy and safety of 44℃ hyperthermia combined with 3% hydrogen peroxide in treating verruca virus.
详细描述
Mild local Hyperthermia with a certain temperature range has been successfully used to treat some diseases. The warm treatment is usually "all or nothing". "All" means that all viral warts are removed after "warm" treatment, including rashes in non-treated areas. "Nothing" means that some viral warts do not respond to heat. Therefore, further enhancing the therapeutic effect of warmth and improving the reaction of some patients is the priority. Cellular experimental studies have found that low concentrations of dioxygen can promote the secretion of a keratinocyte series of inflammatory factors induced by warming. A randomized parallel control design was used to compare the efficacy of hyperthermia combined with hydrogen peroxide therapy and single use of hyperthermia and hydrogen peroxide alone in the treatment of viral warts. Primary analysis: Modified ITT (all randomized patients receiving ≥1 treatment).Missing data: Multiple imputation using chained equations (MICE)
.Between-group comparisons: ANOVA with Tukey posthoc test for continuous variables; Chi-square with Bonferroni correction for categorical variables.Survival analysis: Cox proportional hazards model adjusted for baseline lesion size
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
- None
盲法说明
Masking Description:
- Participants blinded to treatment allocation through:
- Identical-appearing placebo devices with sham light emission
- Opaque containers for topical solutions (H2O2 vs saline)
- Separate treatment rooms per study arm
- Outcome assessors blinded to group assignment
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participants were between 16 and 65 years of age, had a clinical diagnosis of viral warts (including common warts, plantar warts, or condyloma acuminatum), and could understand and sign informed consent.
排除标准
- •presented with clinically atypical warts; had immunocompromised status or a history of HIV infection; received HPV vaccination within the past 6 months; used immunomodulators, immunosuppressants, or systemic corticosteroids within defined timeframes (4 months and 1 month, respectively); underwent local therapies (e.g., laser, cryotherapy, retinoids) on or near warts within protocol-specified intervals; had a history of cutaneous malignancies or current precancerous lesions; exhibited active dermatologic/systemic diseases (e.g., psoriasis, eczema) or skin conditions (e.g., sunburn) potentially increasing study risks; or were deemed ineligible by investigators for other medical or logistical reasons.
研究组 & 干预措施
Local Hyperthermia at 44℃
As an experimental arm.
干预措施: Local Hyperthermia at 44℃ (Device)
Local 3%H2O2 treatment
As an experimental arm
干预措施: Hydrogen Peroxide 3 % Topical Solution (Drug)
3%H2O2 for 1 hour, then local hyperthermia at 44℃ for 30 minutes
Undergo the hyperthermia treatment of the Local Hyperthermia Group and the dressing treatment of the 3% Hydrogen Peroxide Group. Apply the 3% hydrogen peroxide dressing 1 hour before each hyperthermia session.
Local Hyperthermia treats the target warts(largest and most severe warts), while medication addresses all warts.
干预措施: Local Hyperthermia at 44℃ (Device)
3%H2O2 for 1 hour, then local hyperthermia at 44℃ for 30 minutes
Undergo the hyperthermia treatment of the Local Hyperthermia Group and the dressing treatment of the 3% Hydrogen Peroxide Group. Apply the 3% hydrogen peroxide dressing 1 hour before each hyperthermia session.
Local Hyperthermia treats the target warts(largest and most severe warts), while medication addresses all warts.
干预措施: Hydrogen Peroxide 3 % Topical Solution (Drug)
结局指标
主要结局
Complete clearance rate of warts
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.
Time to complete clearance
时间窗: 6 months after the first time of treatment.
Median duration from first treatment to complete resolution (days)
Recurrence rate of warts
时间窗: recurrence was the proportion of patients with reappearance of lesions at previously cleared sites within 6 months after treatment.
Complete clearance was defined as the proportion of patients with complete disappearance of lesions within 6 months of completion of all treatments, and recurrence was the proportion of patients with recurrence of lesions at the cured lesion site within 6 and 12 months after treatment,
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))
- Patient satisfaction score(At 6-month follow-up)
研究者
Gao Xinghua
Professor
First Hospital of China Medical University