NCT05617950尚未招募不适用
Salicylic Acid Versus Cryotherapy for the Treatment of HPV1-induced Plantar Warts: a Randomized Controlled Trial
The 306 Hospital of People's Liberation Army0 个研究点目标入组 174 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
- 174
- 主要终点
- cure rate at 12 weeks
研究概览
简要总结
To evaluate whether salicylic acid was superior to cryotherapy for plantar warts
详细描述
Patients with plantar warts were randomized equally to receive salicylic acid or cryotherapy. Cryotherapy is delivered by a technician up to a maximum of four treatments 3 weeks apart. Thirty percent of salicylic acid is applied once daily by the patient (or parent) for a maximum of 12 weeks. The primary outcomes were the cure rates at 12 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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with HPV1-induced plantar warts.
- •Total number of warts is ≤
- •Aged 12 years or older.
排除标准
- •Patients are currently participating in another trial for the treatment of plantar warts.
- •Patients had received two or more consecutive sessions of cryotherapy, with an interval of no more than 4 weeks (The history of salicylic acid treatment was not considered as criteria for exclusion because high concentration salicylic acid is not commercially available in Chinese mainland).
- •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 salicylic acid or cryotherapy.
结局指标
主要结局
cure rate at 12 weeks
时间窗: 12 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(12 weeks since the initial treatment)
- patient satisfaction with the treatment(12 weeks since the initial treatment)
- treatment-related adverse events(12 weeks since the initial treatment)
研究者
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