Intralesional MMR (Measles,mumps and rubella) vs intralesional BCG (Bacillus calmette -guerin)in the treatment of Verucca vulgaris: A Randomized controlled study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- The proportion of patients achieving complete clearance (100% on VAS) (primary binary outcome used for sample size), assessed at the scheduled follow-ups (treatment visits and final assessment).
研究概览
简要总结
A study on the topic “Intralesional MMR (Measles, Mumps and Rubella) Versus Intralesional BCG (Bacillus calmette -guerin) in the treatment of Verruca Vulgaris: A Randomized Controlled Study”. The study will be conducted for 2-year duration among all verruca vulagris patients attending the Department of Dermatology, Venereology and leprosy of JNIMS during the study interval. The objective of the study is to assess the efficacy of IL MMR and IL BCG and to compare the efficacy of both in the treatment of verruca vulgaris and to determine the Dermatology Life Quality Index in wart patients. In this study, patients with clinically diagnosed verruca vulgaris above 12 years of age will be included. Patients undergoing immunosuppression, underwent any other treatment in the last month before enrolment, pregnant/lactating women, patients with fever or any signs of inflammation or infection, patients with past history of asthma, allergic skin disorders and patients with chronic disease will be excluded. Though number of studies on the subject has been done all over the world, similar studies in India is very few and therefore this study has been taken up to assess the same and compare with rest of the studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 12.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed verruca vulgaris patients.
- •No concurrent treatment for verruca vulgaris.
排除标准
- •Patients with signs and symptoms of infection.
- •Pregnancy and lactation.
- •Age less than 12 years 4) Immunocompromised Individuals.
- •Patients with chronic disease.
- •Patients with a history of asthma and allergic skin disorders.
结局指标
主要结局
The proportion of patients achieving complete clearance (100% on VAS) (primary binary outcome used for sample size), assessed at the scheduled follow-ups (treatment visits and final assessment).
时间窗: The proportion of patients achieving complete clearance (100% on VAS) (primary binary outcome used for sample size), assessed at the scheduled follow-ups (treatment visits and final assessment).-at 3,6,9 and 12weeks and 3months after last dose.
次要结局
- 1.Incidence and severity of adverse effects.(1.Incidence and severity of adverse effects.-in weeks)
研究者
Ravish Bhourya
Jawaharlal Nehru Institute Of Medical Sciences