NCT05616078尚未招募不适用
Laser Versus Cryotherapy for the Treatment of Recalcitrant Warts: a Randomised Controlled Trial
The 306 Hospital of People's Liberation Army0 个研究点目标入组 110 人开始时间: 2022年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 主要终点
- cure rate at 16 weeks
研究概览
简要总结
To evaluate whether laser was superior to cryotherapy for recalcitrant warts
详细描述
Patients with recalcitrant warts were randomized equally to receive laser or cryotherapy every 3 to 4 weeks, for a maximum of 4 sessions.The primary outcomes were the cure rate at 16 weeks; secondary outcomes included time to clearance of warts, patient satisfaction with the treatment and treatment-related adverse effects.
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 with HPV2/27/57-induced recalcitrant warts, including periungualor mosaic warts, common or plantar warts with a duration of longer than 1 year, and common or plantar warts previously received no more than two sessions of cryotherapy
- •Total number of warts is ≤10 .
- •Aged 18 years or older.
排除标准
- •Patients are currently participating in another trial for the treatment of cutaneous warts.
- •Patients have taken immunosuppressant drugs (such as oral corticosteroids) during the past three months.
- •Patients have impaired healing eg due to diabetes, vitamin A deficiency, hyperthyroidism and hypothyroidism.
- •Patients have autoimmune diseases (such as systemic lupus erythematosus, dermatomyositis, scleroderma or other diseases).
- •Patients are pregnant or ready for pregnancies or breast-feeding.
- •Patients have cold intolerance (such as cold urticaria, cryoglobulinaemia, cold agglutinin syndrome or Raynaud's syndrome).
- •Patients have local pain intolerance.
- •Patients have local hypoesthesia.
- •Patients are unable to tolerate laser or cryotherapy.
结局指标
主要结局
cure rate at 16 weeks
时间窗: 16 weeks since the initial treatment
A patient was considered to be cured if all warts were no longer visible and could not be palpated anymore.
次要结局
- time to clearance of warts(16 weeks since the initial treatment)
- patient satisfaction with the treatment(16 weeks since the initial treatment)
- treatment-related adverse events(16 weeks since the initial treatment)
研究者
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