Cryotherapy Versus Laser for the Treatment of Nongenital Cutaneous Warts: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- cure rate
研究概览
简要总结
The purpose of this study is to test the efficacy of laser versus cryotherapy on the treatment of warts
详细描述
Cutaneous warts were a common skin diseases caused by human papilloma virus (HPV) infection. Although warts may spontaneously resolve, many patients seek for treatment for various reasons. There are many kinds of treatments for cutaneous warts, including salicylic acid, cryotherapy, laser, etc. A recent high quality RCT confirmed that the cure rate of topical salicylic acid and frozen has no difference at six months, but the efficacy of laser versus cryotherapy on the treatment of warts remains unclear. Therefore, we designed a randomized controlled trial to test the efficacy of laser versus cryotherapy on the treatment of 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 (Outcomes Assessor)
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
- •Patients have cutaneous warts, including common warts(d≥1cm or n≥5 ), plantar warts, periungual warts, mosaic warts, which are suitable for cryotherapy and laser treatment .
- •patients aged eighting years and over, who have junior school degree or above
排除标准
- •Patients who have more than 20 warts
- •Patients who are currently participating in another trial for the treatment of their warts
- •Patients who took immunosuppressant drugs such as oral corticosteroids within the past three months.
- •Patients who are pregnant or ready for pregnancies or breast-feeding.
- •Patients who have impaired healing eg due to diabetes, vascular disease, vitamin A deficiency, hyperthyroidism and hypothyroidism.
- •Patients who have autoimmune diseases, eg SLE, dermatomyositis, scleroderma and other diseases .
- •Patients who have cold intolerance, eg cold urticaria, cryoglobulinaemia, cold agglutinin syndrome, Raynaud's syndrome.
- •Patients who have local injections intolerance.
- •Patients who have local hypoesthesia .
- •Patients who can not tolerate cryotherapy or laser treatment for their own reasons.
结局指标
主要结局
cure rate
时间窗: Cure rate will be calculated at 16 weeks and 6 months from the first treatment
Warts was considered cured if they was no longer visible and could not be palpated anymore by hand. Assessment of whether or not cured was performed on site by a senior dermatologist
次要结局
- effective rate(Effective rate will be calculated at 16 weeks from the first treatment)
- recurrence rate(Recurrence rate will be calculated at 12 months from the first treatment)
- average cure days(Average cure days will be calculated at 6 months from the first treatment)
- patient satisfaction(Patient satisfactionwill be assessed within 3-4 weeks after each treatment)
- treatment costs(Treatment costs will be recorded within 10 minutes after each treatment)
- relationship between HPV type and curative effect(Relationship between HPV type and curative effect will be analyzed at 16 weeks and 6 months from the first treatment)
- side effects(Side effects will be assessed within 3-4 weeks after each treatment)
- pain intensity(Pain intensity will be assessed within 3-4 weeks after each treatment)
研究者
Shichao Lu
M.D.
The 306 Hospital of People's Liberation Army