Intralesional Therapies For Cutaneous Viral Warts: A Comparative Analysis Of Vitamin D3 And Acyclovir
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Clinical Response at Week 8
研究概览
简要总结
The goal of this clinical trial is to learn if injecting acyclovir (an antiviral drug) or vitamin D3 directly into skin warts works to clear them in people aged 12 and older with common, plantar, flat, or periungual (around the nail) warts. The main questions it aims to answer are:
- Does intralesional acyclovir or vitamin D3 lead to complete clearance of warts by week 8?
- Which treatment clears warts more effectively?
- What side effects do participants have with each treatment?
Researchers will compare acyclovir injections (Group A) to vitamin D3 injections (Group B), with 20 participants in each group, to see which treatment works better at clearing warts.
Participants will:
- Receive an injection directly into the wart every 2 weeks for up to 4 sessions
- Have photographs taken of their warts before treatment and at each visit
- Visit the clinic for checkups where the size and number of warts will be measured
- Be followed for up to 3 months to check for wart recurrence and side 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 aged 12 years and above with clinically diagnosed cutaneous warts
- •Common, plantar, flat, or periungual warts
- •Both treatment-naïve patients and those with recalcitrant warts
排除标准
- •Pregnant or lactating women
- •Immunocompromised patients
- •Individuals with history of hypersensitivity to vitamin D3 or acyclovir
- •Individuals receiving systemic immunosuppressive or antiviral therapy
- •Patients with secondary infection at injection site
- •Patients who had received any topical or destructive treatment for wart in previous three months
研究组 & 干预措施
Intralesional Vitamin D3
Participants receive intralesional injection of vitamin D3 (200,000 IU). Injections are administered at baseline and repeated every 2 weeks for a maximum of four sessions.
干预措施: Intralesional Vitamin D3 (Drug)
Intralesional Acyclovir
Participants receive intralesional injection of acyclovir. Injections are administered at baseline and repeated every 2 weeks for a maximum of four sessions.
干预措施: Intralesional Acyclovir (Drug)
结局指标
主要结局
Clinical Response at Week 8
时间窗: 8 weeks from baseline
Clinical response categorized as complete clearance (100% resolution of wart), partial response (reduction in size or number of warts but not complete clearance), or no response (no change or increase in size or number of warts). Assessed by an independent blinded investigator using clinical examination and standardized digital photographs.
次要结局
- Early Recurrence of Warts(Up to 3 months from baseline)
- Adverse Effects of Treatment(Up to 3 months from baseline)
- Number of Treatment Sessions Required for Complete Clearance(8 weeks from baseline)
研究者
Fatima Sajid
Principal Investigator
Riphah International University