Triple Intralesional Antigen Immunotherapy Versus Monoantigen in the Treatment of Multiple Recalcitrant Warts
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Overall complete response of both treated and distant warts
研究概览
简要总结
Warts can be resistant to treatment or return despite the use of many therapeutic modalities. Combining immunotherapy might contribute to better response rates, particularly in recalcitrant warts, which is a real therapeutic challenge. The purpose of this study was to assess the effectiveness and safety of a triple intralesional immunotherapy combination composed of PPD, Candida antigen and MMR versus either agent alone in the management of multiple recalcitrant warts.
详细描述
This study included 160 patients with multiple (>3 warts) recalcitrant (at least 6 months duration and who did not respond to at least 2 treatment modalities) warts of different sites, size and duration, with or without distant warts after approval of the Institutional Review Board of Faculty of medicine, Zagazig university. They were randomly assigned to one of four groups (each with 40 patients): PPD, Candida antigen, MMR, or combination of the 3 antigens. Injections into the biggest wart were repeated every two weeks until clearance or for a total of five sessions.
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, Investigator)
盲法说明
Double masking
入排标准
- 年龄范围
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple (> 3 warts) recalcitrant (at least 6 months duration and who did not respond to at least 2 treatment modalities) warts of different sites, size and duration
排除标准
- •Patients with acute febrile illness or past history of asthma.
- •Allergic skin disorders such as generalized eczema and urticaria.
- •Past history of meningitis or convulsions.
- •Pregnancy or lactation.
结局指标
主要结局
Overall complete response of both treated and distant warts
时间窗: within 12 weeks of starting treatment sessions (up to 1 month after the last session, maximum 5 sessions)
Immediate adverse effects
时间窗: during and till 20 minutes after intralesional injection immunotherapy
次要结局
- Time to complete clearance(within 12 weeks of starting therapy)
- Distant wart clearance(within 12 weeks of starting sessions)
- late adverse effects(after each session and till the end of sessions and 6 months-follow-up period)
- Recurrence(For 6 months after complete response)
研究者
Basma Magdy Elkholy, MD
Dr
Zagazig University