Efficacy and Safety of 980nm Diode Laser Versus Liquid Nitrogen Cryotherapy for the Treatment of Plantar Warts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- Skin pattern
研究概览
简要总结
The goal of this clinical trial is to compare and test the efficacy of two treatments for plantar warts. The main questions it aims to answer are:
Which treatment has a higher cure rate for eliminating plantar warts? Which treatment causes less pain during the procedure?
Participants with plantar warts will:
Be randomly assigned to receive either cryotherapy or laser therapy Undergo 4 treatment sessions at weekly intervals Have their warts assessed for complete clearance after treatment Rate their pain levels during each session
Researchers will compare the cryotherapy and laser therapy groups to see if there are differences in:
Rates of complete wart clearance Pain levels reported during treatment Adverse effects
详细描述
Background: Plantar warts are a common dermatological condition caused by human papillomavirus infection. They can be painful and negatively impact quality of life. Many treatments exist but there is lack of consensus on the optimal approach.
Objectives:
Primary objective: To compare the efficacy of 980nm diode laser versus liquid nitrogen cryotherapy for clearing plantar warts, as measured by the complete clearance rate at 4 weeks post-treatment.
Secondary objectives: To evaluate and compare pain levels during treatment procedures and adverse events between both groups.
Study design: Randomized, double-blind clinical trial.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with recalcitrant, mosaic and simple HPV
排除标准
- •Diabetic, ischaemic and immunosuppressed patients
- •Patients with cold intolerance
- •Patients with any of the following conditions (blood dyscrasias of unknown origin, cryoglobulinaemia, cryofibrinogenemia, collagen or autoimmune disease)
- •Patients who do not sign the informed consent form.
结局指标
主要结局
Skin pattern
时间窗: 7 days from first application
Interrupted plantar lines with irregularly distributed dots.classifies the severity in 3 degrees, from the absence of alterations (0) to the extensive presence of interrupted lines and irregular spots in the plantar skin pattern (3).
次要结局
- VAS scale(7 days from first application)
- complications(7 days from first application)