A Prospective Comparative Interventional Study to Determine the Safety and Efficacy of Intralesional Acyclovir versus Vaccine MMR in the treatment of Viral warts- RANDOMIZED CONTROL TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This study is a prospective, randomized, comparative interventional trial designed to evaluate and compare the efficacy and safety of intralesional acyclovir versus intralesional MMR vaccine in the treatment of cutaneous viral warts. Viral warts, caused by human papillomavirus (HPV), are common dermatological conditions with variable response to conventional destructive therapies and a tendency for recurrence, prompting the need for effective immunomodulatory or antiviral alternatives
A total of 60 adult patients (>18 years) with clinically diagnosed palmar, plantar, periungual, or subungual warts will be recruited and randomly allocated into two groups. Group A will receive intralesional acyclovir (70 mg/mL), and Group B will receive intralesional MMR vaccine, administered every two weeks for up to six sessions or until complete clearance. Treatment response will be assessed using objective reduction in wart size and number (graded G0–G4), physician global assessment, and patient satisfaction scores, with follow-up for adverse effects and short-term recurrence
The primary objective is to compare therapeutic efficacy between the two modalities, while secondary objectives include evaluation of safety and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Clinically diagnosed cases of plantar, palmar, periungual, and subungual warts
- •Age between 18 years and 65 years.
排除标准
- •1.Known history of hypersensitivity to Acyclovir and MMR vaccine 2.Pregnancy and lactation 3.Immunocompromised status 4.Secondary infection/ulceration.
- •5.Patients with fever or signs of any inflammation or infection, meningitis, and convulsions.
- •6.Patients with any history of asthma, allergic skin disorders, hypersensitivity, or allergy to vaccines.
- •7.Patients with any history of concurrent systemic, or topical treatment of warts within the past 4 weeks.
- •8.Patients with genital/mucosal warts/plane warts.
研究者
Dr K Vidhi Jain
KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH DEEMED TO BE UNIVERSITY, BELGAVI
