NCT04278573已完成2 期
Efficacy of Intralesional Vitamin D Injection for Treatment of Common Warts: A Randomized Controlled Trial
Stephen P. Merry1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2020年10月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Complete Regression of Wart
研究概览
简要总结
Researchers are trying to find out if injecting Vitamin D into a wart is an effective treatment.
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)
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 seen at the Mayo Clinic Rochester practices
- •Patients suffering from one or more cutaneous warts as diagnosed by the examining physician at baseline visit on typical diagnostic characteristics
- •Able to provide consent
- •Both recalcitrant and non-recalcitrant warts will be included
排除标准
- •Patients with prior use of home or office-based destructive treatments for this wart(s) in the last 1 month with salicylic acid (SA) or cryotherapy
- •Immunoadjuvant therapy for warts in the last 4 months (e.g Candida)
- •History of vitamin D injection of warts ever
- •High-dose vitamin D supplementation (>4,000 IU daily or equivalent) in the preceding 3 months
- •Pregnancy or lactation
- •Facial or genital warts
- •Lesions not felt by the examining clinician to be a wart (e.g., corns or calluses)
- •Immunosuppression (to include immunosuppressive medications or conditions as judged by the physician evaluating the patient at the baseline visit).
- •Allergy to sesame oil
研究组 & 干预措施
Vitamin D3 Treatment Group
Experimental
Subjects will receive a Vitamin D3 injection into their wart
干预措施: Vitamin D3 (Drug)
Placebo Group
Placebo Comparator
Subjects will receive a placebo injection into their wart
干预措施: Placebo (Drug)
结局指标
主要结局
Complete Regression of Wart
时间窗: 24 weeks
Number of subjects to have a complete resolution of cutaneous wart
次要结局
- Regression of Wart at 4 Weeks(4 weeks)
- Regression of Wart at 8 Weeks(8 weeks)
- Regression of Wart at 12 Weeks(12 weeks)
研究者
Stephen P. Merry
Principal Investigator
Mayo Clinic
研究点 (1)
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