Randomized Pilot Study Investigating the Safety and Efficacy of Topical Cantharidin for the Treatment of Molluscum Contagiosum
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 94
- 主要终点
- Number of Subjects Who Achieve Complete Clearance at 6 Weeks
研究概览
简要总结
The purpose of this study is to determine if cantharidin is a safe and effective treatment for molluscum contagiosum in kids
详细描述
This was a double-blind, placebo-controlled trial. Participants were recruited from the Pediatric Dermatology clinic at Montefiore Medical Center. One hundred eligible participants were randomly assigned to receive cantharidin 0.7% topical, cantharidin 0.7% topical with occlusion, placebo, or placebo with occlusion. Treatments were applied at weeks 0 and 3 (blinded phase). At week 6, all participants were treated with open-label, topical cantharidin 0.7% without occlusion every 3 weeks until all lesions resolved (open-label phase).
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •2-17years
- •<50 molluscum contagiosum lesions
排除标准
- •Immunosuppressed
- •Oral corticosteroids
- •Sexually active/pregnant
研究组 & 干预措施
Cantharidin with occlusion
Cantharidin 0.7% topical with occlusion
干预措施: Cantharidin (Drug)
Cantharidin with occlusion
Cantharidin 0.7% topical with occlusion
干预措施: Gauze occlusion bandage (Device)
Cantharidin without occlusion
Cantharidin 0.7% topical without occlusion
干预措施: Cantharidin (Drug)
Placebo with occlusion
Placebo topical with occlusion
干预措施: Placebo (Drug)
Placebo with occlusion
Placebo topical with occlusion
干预措施: Gauze occlusion bandage (Device)
Placebo without occlusion
Placebo topical without occlusion
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects Who Achieve Complete Clearance at 6 Weeks
时间窗: 6 weeks
Assess number of subjects who achieve a lesion count of zero at 6 weeks (end of open-label phase)
次要结局
- Number of Subjects Who Experienced an Adverse Event(33 weeks)
研究者
Steven R Cohen
Professor
Montefiore Medical Center