Comparative analysis of efficacy between homologous autoimplantation therapy and intralesional MMR vaccine in the treatment of viral warts.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Reduction in size of wart assessed by VAS scoring system
研究概览
简要总结
Purpose of the trial - Multiple warts are difficult to treat with destructive procedures like fulguration and ablation as they may cause permanent scarring. Immunotherapy
using intralesional MMR vaccine has been found useful in treating common warts especially in
children. Homologous autoimplantation is a simple technique, which helps in inducing a good cell-mediated immune response, essential for the clearance of warts. Only few studies have evaluated the efficacy of intralesional MMR and Autoimplantation with equivocal results.
Brief Summary
To do comparative analysis of safety and efficacy between homologous autoimplantation therapy and intralesional MMR vaccine in the treatment of viral warts. Study design is Randomised Control Trial. Patients more than 12 yrs of age with multiple warts (less than 10 in number), non-pregnant, non-lactating, immunocompetent who are willing to participate will be enrolled in the study after taking informed consent. Sample size is 56, 28 in each group Intralesional MMR and homologous autoimplantation respectively.
Time points for assessment will be baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks. Assessment will be done using VAS score at each time point. Data will be analysed using statistical
software R version 4.2.3 and Microsoft Excel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 13.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients more than 12 years of age with multiple warts less than 10 in number who are willing to participate in the study.
排除标准
- •Single wart 2)Pregnant or planning pregnancy in the next three months 3)Lactating women 4)Patients with local dermatological condition 5)Patients with apparent infection, immunosuppression, or are on immunosuppressive drugs, asthma, allergic skin disorders, meningitis or convulsions.
结局指标
主要结局
Reduction in size of wart assessed by VAS scoring system
时间窗: Baseline,3 weeks, 6 weeks, 9 weeks, 12 weeks
次要结局
- To assess adverse reactions in Inralesional Injection MMR & Autoimplantation(Baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks)
研究者
Anusha N A
Jawaharlal Nehru Medical College, Belagavi