A Self-controlled Study of Bleomycin and Pingyangmycin Injection in the Treatment of Plantar Warts
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Skin lesions completely cleared
研究概览
简要总结
All patients were treated as self-control. Half of the warts received bleomycin injection and the other half received pingyangmycin injection for 24 weeks. During the treatment period, before each injection, photos of the skin lesions must be taken, the diameter of the skin lesions must be measured, the DLQI(Dermatology Life Quality Index) and NRS scores(NRS scores) must be filled in, and adverse events must be recorded. Before the first treatment, HPV(Human Papilloma virus) virus typing is performed on the 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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged over 18 years old;
- •Clinical diagnosis of plantar warts;
- •The diameter of a single wart is ≥1cm, and the number is ≥2;
- •There is a history of other treatments for plantar warts within 4 weeks, including drugs and physical therapy;
- •Have a basic understanding of the purpose, effects and possible adverse reactions of the trial, and sign an informed consent form in accordance with the spirit of the Declaration of Helsinki.
排除标准
- •There are other local infections in the treatment area and injection is not suitable;
- •Patients allergic to lidocaine, bleomycin, and pingyangmycin;
- •Patients with other serious skin diseases, tumors or other systemic diseases;
- •Patients with infections such as tuberculosis, HIV, hepatitis B, hepatitis C;
- •Patients with a history of other treatments for plantar warts in the previous 4 weeks, including drugs and physical therapy;
- •Patients who have participated in other clinical trials in the past 3 months;
- •Pregnant women, lactating women, or patients who plan to become pregnant during the trial;
- •Those who have any history of major surgery in the previous 8 weeks or who may have surgery planned during treatment;
- •Patients with a history of mental illness.
研究组 & 干预措施
Pingyangmycin group
干预措施: Pingyangmycin Injection (Drug)
Bleomycin group
干预措施: Bleomycin injection (Drug)
Bleomycin Combined with Local Hyperthermia
干预措施: Bleomycin injection (Drug)
结局指标
主要结局
Skin lesions completely cleared
时间窗: Week 24
The patient's plantar wart lesions were completely cleared
Skin lesions completely cleared
时间窗: 2026.11.1
The patient's plantar wart lesions were completely cleared
次要结局
- Follow up to 36 weeks with no recurrence(Week 52)
- Follow up to 36 weeks with no recurrence(2026.11.1)