Topical Hydrogen Peroxide 40% Versus Salicylic Acid 40% in the Treatment of Plantar Warts: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Number of participants with complete clinical clearance
研究概览
简要总结
This randomized controlled trial aims to compare the efficacy and safety of topical hydrogen peroxide 40 percent versus topical salicylic acid 40 percent in the treatment of plantar warts.
详细描述
Plantar warts are common benign lesions caused by human papillomavirus on weight-bearing areas causing pain and functional impairment. This is a randomized parallel assignment study conducted at the Outpatient Dermatology Clinic Assiut University Hospital. Eligible patients with clinically diagnosed plantar warts will be randomized in 1 to 1 ratio to topical hydrogen peroxide 40 percent applied once weekly by physician or topical salicylic acid 40 percent self-applied once daily. Treatment duration 12 weeks with assessments every 2 weeks including measurement size photographs clearance status adverse effects compliance and satisfaction.
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
- •Age greater than or equal to 12 years of both sexes
- •Clinically diagnosed plantar wart or warts
- •Wart duration at least 2 weeks prior to enrollment
- •Willing and able to give written informed consent or parental consent for minors
- •Able to attend follow-up visits and comply with home-application protocol
排除标准
- •Pregnant or lactating women
- •Immunocompromised patients including HIV infection organ transplant recipients or on immunosuppressive therapy
- •Diabetic patients with peripheral neuropathy or peripheral arterial disease
- •Known hypersensitivity to hydrogen peroxide or salicylic acid
- •Received any topical or systemic wart treatment within preceding 4 weeks
- •Clinically atypical lesions raising suspicion of malignancy
- •Active local skin infection or open wound at treatment site
- •Unable or unwilling to complete follow-up schedule
研究组 & 干预措施
Topical Hydrogen Peroxide 40%
Stabilized topical hydrogen peroxide 40 percent w/w applied directly onto wart surface using single-use wooden-tipped applicator avoiding surrounding skin once weekly by physician for 12 weeks or until complete clearance after soaking foot 5 to 10 minutes and gentle debridement
干预措施: Hydrogen Peroxide 40% (Drug)
Topical Salicylic Acid 40%
Commercially available salicylic acid 40 percent w/w as paint or plaster self-applied once daily onto wart surface with protection of surrounding skin with petrolatum for 12 weeks after soaking and gentle paring
干预措施: Salicylic Acid 40% (Drug)
结局指标
主要结局
Number of participants with complete clinical clearance
时间窗: At 12 weeks
Number of participants with complete clinical clearance defined as complete disappearance of plantar wart and restoration of normal skin markings
次要结局
- Time to complete clearance(Up to 12 weeks)
- Change in wart surface area(From baseline to 12 weeks)
- Treatment-related pain score(Up to 12 weeks)
- Number of participants with local adverse effects(Up to 12 weeks)
- Patient satisfaction score(At 12 weeks)
- Number of participants with recurrence(Up to 12 weeks)
研究者
Mohamed Ahmed Abdelrady Mahmoud
Resident Physician
Assiut University