Human Papillomavirus (HPV) Vaccination for the Treatment of Refractory Cutaneous Warts: A Randomized, Placebo-Controlled, Double-Blinded Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts (response information may be found in description) at 24 weeks
研究概览
简要总结
This double-blinded clinical trial randomly assigns participants with refractory cutaneous warts to receive either treatment with the human papillomavirus (HPV) vaccine or a placebo to assess the efficacy of HPV vaccination for the treatment of refractory cutaneous warts.
详细描述
Cutaneous warts are a common cause for medical office visits and are frequently encountered in dermatology practice. Despite their benign nature, cutaneous warts can be painful, disfiguring, persistent and may be associated with significant morbidity. Numerous therapeutic options are available, including local destruction, virucidal agents, topical and systemic antiproliferative medications, and immunotherapy. Unfortunately, no single therapy is uniformly effective, and patients often receive multiple courses of treatment (cryotherapy, curettage, Candida antigen injection, etc.) without improvement.
An efficacious therapy for cutaneous warts is sorely needed and treatment with HPV vaccination is being increasingly reported. Notably, individual cases and case series have reported complete resolution of multiple treatment refractory warts after treatment with the quadrivalent HPV vaccine. Even more encouraging, a larger retrospective study of 30 patients found that up to 60% of patients had a complete or partial response after treatment with the HPV vaccine. Additional benefits of treatment with HPV vaccination include ease of use, less tissue destruction and pain, and the potential for less frequent medical office visits. Despite these promising preliminary data, a larger, randomized controlled study has yet to be performed.
This will be a multi-center, double-blinded, randomized, placebo-controlled trial with 120 participants. Enrolled participants will be randomized to treatment with either HPV vaccination or placebo. Participants will receive injections with the 9-valent HPV vaccine or placebo at 0, 4, and 20 weeks and follow up until 24 weeks to determine their treatment response, quality of life and the safety and tolerability of HPV vaccination.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Investigators and Nurses share the role as Care Provider. Investigators will be blinded to the treatment allocation. Nurses, however, will be aware of the treatment allocation as they are administering the injections. Nurses are not involved in the study conduct in any other way.
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
- •Must be able to understand and provide written informed consent
- •Age 18 or older
- •Clinical diagnosis of cutaneous warts
- •Must have received prior treatment for cutaneous warts (such as curettage, cryotherapy, salicylic acid, intralesional Candida antigen injection, etc.)
排除标准
- •Untreated cutaneous warts
- •Anogenital warts
- •Treatment for cutaneous warts in the past 4 weeks
- •Active acute illness
- •Immunosuppression
- •Known hypersensitivity to HPV vaccination
- •Subjects may not receive any other investigational treatment
- •Pregnancy or planned pregnancy during the study period
结局指标
主要结局
Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts (response information may be found in description) at 24 weeks
时间窗: Response to treatment assessments will occur 24 weeks after first dose of vaccine/placebo (primary endpoint)
Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts, classified as: (1) complete response (CR; complete clearance of warts); (2) partial response (PR; any decrease in lesion number or size); or (3) no response (NR; no change or increase in lesion number or size)
Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts (response information may be found in description) at 4 weeks
时间窗: Response to treatment assessments will occur 4 weeks after first dose of vaccine/placebo
Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts, classified as: (1) complete response (CR; complete clearance of warts); (2) partial response (PR; any decrease in lesion number or size); or (3) no response (NR; no change or increase in lesion number or size)
Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts (response information may be found in description) at 8 weeks
时间窗: Response to treatment assessments will occur at 8 weeks after first dose of vaccine/placebo
Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts, classified as: (1) complete response (CR; complete clearance of warts); (2) partial response (PR; any decrease in lesion number or size); or (3) no response (NR; no change or increase in lesion number or size)
次要结局
- Skindex-16(Quality of life assessments will occur at 0 (baseline), 4, 8, and 24 weeks (primary endpoint))
- Incidence of Treatment-Emergent Adverse Events(Safety assessment will occur at 0, 4, 8, 20, and 24 weeks)