Open-Label Pilot Study of the Efficacy and Safety of Vusion Ointment for the Treatment of Intertrigo
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The number of patients for whom Vusion effectively treated intertrigo
研究概览
简要总结
The purpose of this study is to determine if people with moist, red, patches on their skin in body folds would benefit treatment of those areas with an FDA-approved drug called Vusion.
详细描述
Intertrigo is an inflammatory condition of skin folds, induced or aggravated by heat, moisture, maceration, friction, or lack of air circulation. It is typically chronic with insidious onset of itching, burning, and stinging within the affected skin folds. Intertrigo frequently worsened or colonized by infection, which most commonly is candidal but also may be bacterial, fungal, or viral. The etiology of diaper dermatitis shows significant overlap with that of intertrigo. Vusion ointment, a highly effective treatment for diaper dermatitis, has been used by physicians for the treatment of intertrigo; however, there is a paucity of data in the literature regarding the use of Vusion ointment in this indication.
This study is the first to formally investigate the efficacy and safety of Vusion ointment for the treatment of intertrigo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Evidence of intertrigo
排除标准
- •Pregnancy
- •Use of systemic or topical antifungal or corticosteroid treatment in the previous 14 days or during the 3-month treatment period
- •allergy of sensitivity to Vusion
- •undergoing warfarin anticoagulation
- •alcohol or drug abuse
- •Investigator determines they cannot particpate
- •history of non-compliance or poor cooperation
- •participation in an investigaitonal drug study within 30 days of Baseline Visit
研究组 & 干预措施
Vusion ointment
干预措施: Vusion (Drug)
结局指标
主要结局
The number of patients for whom Vusion effectively treated intertrigo
时间窗: 3 months
次要结局
未报告次要终点