Intralesional Acyclovir Versus Cryotherapy in the Treatment of Plantar Warts. A Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Cure rate
研究概览
简要总结
The goal of this prospective randomized controlled study is to study the safety and efficacy of intralesional acyclovir compared to cryotherapy in plantar warts. The main questions needed to be answered are:
- Is Intralesional acyclovir safe for plantar warts?
- Is Intralesional acyclovir more efficient in treating plantar warts compared to cryotherapy?
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older, of both genders, with plantar warts
排除标准
- •Patients on systemic treatment for warts eg. Acitretin, Acyclovir
- •Hypersensitivity to Acyclovir
- •Previous treatment to the same wart during the last 3 months
- •Immunocompromised patients (as HIV, steroid intake, uncontrolled diabetes, etc.)
- •Pregnant and breastfeeding females
- •Cognitively impaired patients
研究组 & 干预措施
Intralesional Acyclovir
Intralesional acyclovir will be prepared by diluting 1 ampoule of Acyclovir 250mg into 3.5ml of saline solution to achieve a concentration of approximately 70mg/ml. Then 0.1ml will be injected intra-lesionally into the base of the wart. Any hyperkeratotic lesions should be pared before the treatment. This process will be repeated every 2 weeks for 5 sessions, and can be discontinued if complete resolution is achieved early.
干预措施: Intralesional Acyclovir (Drug)
Cryotherapy
Patients allocated to Group B will undergo cryotherapy using a liquid nitrogen spray gun. Any hyperkeratotic lesions should be pared before the treatment. Two freeze-thaw cycles will be applied each session, the spray gun should be held 1cm away from the wart and maintained until the wart and the 1-3mm of surrounding skin shows freezing, and each cycle should last 15 seconds. Next, the lesion will be left to thaw completely before starting the second cycle. This process will be repeated every 2 weeks for 5 sessions, and can be discontinued if complete resolution is achieved early
干预措施: Cryotherapy (Device)
结局指标
主要结局
Cure rate
时间窗: 10 weeks (5 sessions max)
Number of patients healed after completion of the sessions
Patient satisfaction score
时间窗: 10 weeks
Patient satisfaction questionnaire score
Recurrence rate
时间窗: 24 weeks
Number of patients had recurred plantar warts after receiving the treatment
次要结局
- Correlation of treatment with gender(10 weeks)
- Correlation of treatment with number of ipsilateral warts(10 weeks)
- Correlation of treatment with age(10 weeks)
- Correlation of treatment with size of the wart(10 weeks)
研究者
Basant Ahmed Mohamed Abdelaal Helal
Dermatology Resident
Cairo University