Quadrivalent and Bivalent Human Papilloma Virus Vaccines in the Treatment of Common Recalcitrant Warts
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Therapeutic response
研究概览
简要总结
Warts are common, benign, epidermal proliferations caused by HPV infecting skin and mucous membranes. Treatment of warts poses a true challenge despite existing variable therapeutic modalities, whether destructive or immunotherapeutic. Human papilloma virus (HPV) vaccines are FDA approved for the prevention of genital warts and wart related precancerous and cancerous lesions but they are not indicated for treatment of preexisting warts yet
详细描述
Approximately 35% of viral warts tend to be recalcitrant either showing no response to treatment or having prompt recurrences after treatment, causing frustration for both patients and physicians. Success rates vary significantly across patients and across different therapeutic interventions ranging from 7% to 90%.
Immunotherapy is proposed to enhance virus recognition by the cell mediated immunity, which allows the clearance of both treated and untreated warts and helps to prevent recurrences through induction of a long-term acquired immunity to HPV.
Few reports suggest the possibility of using quadrivalent or bivalent HPV vaccines as therapeutic modality rather than only preventive modality. This is a randomized controlled study to assess the efficacy and safety of quadrivalent and bivalent HPV vaccines in the treatment of warts
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Patients with recalcitrant multiple warts of any type. Warts were considered recalcitrant if they persisted for at least 6 months without any response to 2 different therapeutic modalities or more.
- •Immunocompetent patients.
- •Patients who do not receive any treatment of warts for at least 1 month before the start of study.
- •Patients who are able to understand and follow the study protocol and approve to sign the informed consent
排除标准
- •Patients with acute febrile illness.
- •Past history of asthma.
- •Allergic skin disorders, such as generalized eczema, or severe urticaria.
- •Pregnancy or lactation
- •History of hypersensitivity to the treatment vaccines.
- •Immunocompromised patients
- •Patients unable to follow the study protocol
研究组 & 干预措施
Quadrivalent vaccine
Patient receive 0.1 ml of quadrivalent HPV vaccine intralesional every two weeks
干预措施: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine (Drug)
Bivalent Vaccine
Patient received 0.1 ml of bivalent HPV vaccine intralesional once every two weeks
干预措施: Bivalent Human Papilloma Virus Vaccine (Drug)
Saline control
Patient received 0.1 ml of intralesional saline once every two weeks
干预措施: Saline (Drug)
结局指标
主要结局
Therapeutic response
时间窗: Through study completion for a maximum of 12 weeks, evaluation held at two weeks interval and at the end of treatment sessions (12th week visit)
The percentage of patients in each group achieving complete, partial or no response at the end of the treatment sessions
次要结局
- Safety measure(Through study completion for a maximum of 12 weeks held every two weeks till the end of the treatment sessions (12th week visit))
- Recurrence(6 months following the end of treatment sessions)
研究者
Hagar Nofal
Clinical Professor
Zagazig University