A Randomized, Parallel-Group, Controlled, Assessor-Blinded Clinical Trial of Hyperthermia Combined With Hydrogen Peroxide Microneedle Patch for Viral Warts
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 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. Significant progress has been made in the application of hyperthermia for viral skin diseases. Clinically, the addition of hydrogen peroxide solution can enhance the efficacy of hyperthermia in treating HPV infection. As a common transdermal drug delivery method, microneedles can increase drug penetration and thereby further improve treatment outcomes. Based on these findings, this study aims to explore an adjunctive approach to hyperthermia for treating viral warts to further enhance therapeutic efficacy.
This study employs a randomized, parallel-group, assessor-blinded design. Participants will be randomly assigned to three groups: hyperthermia alone, hyperthermia combined with microneedle patch (loaded with 0.9% saline), and hyperthermia combined with hydrogen peroxide microneedle patch (experimental group). An adaptive design will be adopted. The sample size is estimated at 70 participants per group, accounting for a potential 20% dropout rate. Interim analyses will be conducted during follow-up, and enrollment will be stopped when a positive result is reached for the primary efficacy endpoint (cure rate), at which point the sample size will be adjusted accordingly.
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
入排标准
- 年龄范围
- 6 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6-65 years, male or female;
- •Clinically diagnosed with common warts, palmar/plantar/digital warts (≥1 lesion), with a Physician's Wart Assessment score ≥2 (0: no visible wart, no further treatment required; 1: visible wart, diameter <3 mm; 2: single wart diameter ≥3 mm and <6 mm; 3: single wart diameter ≥6 mm);
- •The subject or legal guardian is able to understand and sign the informed consent form and agrees to participate in the study.
排除标准
- •Subjects presenting with atypical warts clinically;
- •Subjects with immune dysfunction or autoimmune diseases;
- •Pregnant or breastfeeding women;
- •Subjects who have received human papillomavirus (HPV) vaccination within the past 6 months;
- •Subjects who have undergone the following systemic treatments within the specified time frames: immunomodulators/immunosuppressants (e.g., etanercept), within 4 months; corticosteroids (inhaled and intranasal use permitted), within 1 month;
- •Subjects who have received the following treatments on or around the warts within the specified time frames: laser or other photochemical therapies (intense pulsed light, photodynamic therapy), within 3 months; immunotherapy (candida antigen), within 4 months; cryotherapy with liquid nitrogen, within 2 months; hydrogen peroxide, within 3 months; antimetabolite therapy (5-fluorouracil), within 2 months; retinoids, within 3 months;
- •Subjects with a history of the following diseases prior to enrollment: skin malignancy within the past 6 months, premalignant skin conditions (actinic keratosis) within the past 6 months, or currently in the acute progressive phase of skin or systemic diseases (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.) or presenting with conditions (such as sunburn, open wounds) that may increase the risk of participation or interfere with evaluation;
- •Subjects with diseases affecting skin healing, such as diabetes mellitus, vitamin A deficiency, etc.;
- •Subjects with cold-sensitive conditions such as cryoglobulinemia or cold urticaria that may lead to abnormal observation results;
- •Subjects with severe dysfunction of the heart, lung, liver, kidney, hematopoietic system, or other vital organs.
研究组 & 干预措施
Hyperthermia at 44°C
Sterile cotton soaked in normal saline was applied to cover each wart, followed by occlusion with plastic film for one hour, once daily, for six consecutive weeks. One wart was selected to receive 44 °C hyperthermia for 30 minutes per session: three consecutive sessions in the first week, two sessions in the second week, and two sessions in the third week. Hyperthermia was administered immediately after occlusion, during which the wart was rinsed with normal saline and gently dried with a sterile cotton swab before the start of hyperthermia.
干预措施: Hyperthermia at 44℃ (Device)
Hyperthermia at 44°C
Sterile cotton soaked in normal saline was applied to cover each wart, followed by occlusion with plastic film for one hour, once daily, for six consecutive weeks. One wart was selected to receive 44 °C hyperthermia for 30 minutes per session: three consecutive sessions in the first week, two sessions in the second week, and two sessions in the third week. Hyperthermia was administered immediately after occlusion, during which the wart was rinsed with normal saline and gently dried with a sterile cotton swab before the start of hyperthermia.
干预措施: 0.9 % saline (Drug)
Hyperthermia combined with microneedle patch (loaded with 0.9% saline)
One wart was selected to receive 44 °C hyperthermia for 30 minutes per session: three consecutive sessions in the first week, two sessions in the second week, and two sessions in the third week. A microneedle patch loaded with 0.9% saline was applied to the target lesion daily for one hour per day, for a total of six weeks.
干预措施: 0.9 % saline (Drug)
Hyperthermia combined with microneedle patch (loaded with 0.9% saline)
One wart was selected to receive 44 °C hyperthermia for 30 minutes per session: three consecutive sessions in the first week, two sessions in the second week, and two sessions in the third week. A microneedle patch loaded with 0.9% saline was applied to the target lesion daily for one hour per day, for a total of six weeks.
干预措施: Hyperthermia at 44℃ (Device)
Hyperthermia combined with microneedle patch (loaded with 0.9% saline)
One wart was selected to receive 44 °C hyperthermia for 30 minutes per session: three consecutive sessions in the first week, two sessions in the second week, and two sessions in the third week. A microneedle patch loaded with 0.9% saline was applied to the target lesion daily for one hour per day, for a total of six weeks.
干预措施: Microneedle patch (Device)
Hyperthermia combined with hydrogen peroxide microneedle patch
One wart was selected to receive 44 °C hyperthermia for 30 minutes per session: three consecutive sessions in the first week, two sessions in the second week, and two sessions in the third week. A hydrogen peroxide microneedle patch was applied to the target lesion daily for one hour per day, for a total of six weeks.
干预措施: Hyperthermia at 44℃ (Device)
Hyperthermia combined with hydrogen peroxide microneedle patch
One wart was selected to receive 44 °C hyperthermia for 30 minutes per session: three consecutive sessions in the first week, two sessions in the second week, and two sessions in the third week. A hydrogen peroxide microneedle patch was applied to the target lesion daily for one hour per day, for a total of six weeks.
干预措施: 3% hydrogen peroxide solution (Drug)
Hyperthermia combined with hydrogen peroxide microneedle patch
One wart was selected to receive 44 °C hyperthermia for 30 minutes per session: three consecutive sessions in the first week, two sessions in the second week, and two sessions in the third week. A hydrogen peroxide microneedle patch was applied to the target lesion daily for one hour per day, for a total of six weeks.
干预措施: Microneedle patch (Device)
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 months 1, 3, and 6)
- 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))
- Time to first wart clearance(At months 1, 3, and 6)
研究者
Gao Xinghua
Professor
First Hospital of China Medical University