跳至主要内容
临床试验/NCT03183765
NCT03183765已完成4 期

Intralesional Measles, Mumps, Rubella (MMR) Vaccine Versus Cryotherapy in Treatment of Multiple Common and Planter Warts : a Randomized Controlled Trial

Assiut University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
48
试验地点
1
主要终点
Cure rate

研究概览

简要总结

Warts are benign epidermal tumors caused by human papilloma virus, which are epitheliotropic non-enveloped double stranded DNA viruses. Transmission of warts occurs from direct person-to-person contact or indirectly by fomites . Warts appear in various forms including verruca vulgaris, plane, plantar, filiform, digitate and periungual.

详细描述

Treatment of warts is difficult for patients and physicians . Currently Available treatment options include cryosurgery, laser, electrosurgery, bleomycin, and topical keratolytic applications; many of them are painful, ineffective, costly and prone for recurrences.

Cryotherapy, which uses liquid nitrogen to freeze tissues and destroy warts, is one of the most common and effective treatments. freezing causes local irritation, leading the host to mount an immune reaction against the virus.

Immunotherapy appears to enhance virus recognition by immune system; allowing clearance of treated wart, distant warts , and helps to prevent infection .Recently, intralesional immunotherapy using different antigens such as mumps, Candida, and tuberculin has been proved effective in the treatment of warts.

The exact mechanism of action of intralesional immunotherapy is still obscure. Intralesional antigen injection probably induces strong non specific inflammatory response against the human papilloma virus-infected cells.

It has been suggested that intralesional measles mumps rubella vaccine results in regression of warts via induction of immune system.

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
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients should have multiple common or plantar warts.
  • No concurrent systemic or topical treatment of warts

排除标准

  • patients under 16 years old.
  • Patients with fever or signs of any inflammation or infection.
  • Patients with other types of warts.
  • Patients with single warts.
  • Pregnancy.
  • Lactation.
  • Immunosuppression.
  • Patients who received any other treatments for their warts in the month before starting study.
  • Past history of asthma, allergic skin disorders, meningitis or convulsions.

研究组 & 干预措施

MMR vaccine

Experimental

Measles-Mumps-Rubella Vaccine will be injected 0.5 ml into the largest wart at 2-week intervals until complete clearance was achieved or for a maximum of 3 treatments

干预措施: Measles-Mumps-Rubella Vaccine (Drug)

Cryotherapy

Active Comparator

patients received cryotherapy with liquid nitrogen once every 2 weeks until complete clearance or for a maximum of 3 sessions

干预措施: cryotherapy (Procedure)

结局指标

主要结局

Cure rate

时间窗: 60 days

Assess cure rate of MMR vaccine and cryotherapy in treatment of common and planter warts (complete disappearance of lesions) one month after last session, compare efficacy of both measures.

次要结局

  • Detection of partial response to both measures(60 days)
  • Side effects(60 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

GAbdelsamea

Principal Investigator

Assiut University

研究点 (1)

Loading locations...

相似试验