CelAgace™ OraRinse (CAOR) Pilot Clinical Study for Management of Candidiasis Associated With Grade 0-II Mucositis
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Clinical cure as demonstrated by change and reduction from baseline in typical candida lesions and a negative candida rinse culture
研究概览
简要总结
CelAgace™ OraRinse (silver citrate complex and acemannan) Solution is planned to be evaluated for safety and effectiveness as a potential treatment for candidiasis, a yeast infection, commonly known as thrush, which is associated with mouth sores.
详细描述
CelAgace™ contains two active ingredients, a silver citrate complex salt (0.01mg/ml) that has demonstrated laboratory effectiveness against yeast organisms and acemannan (4.0mg/ml), a purified extract isolated from the inner leaf gel of the Aloe vera plant that has been used as a key ingredient in other oral care products. Patients will swish and spit the product 4 times daily (after meals and at bedtime) for 14 days. Following an initial office visit, patients will be evaluated on days 7 and 14 to determine response to the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Radiation induced oral mucositis with resulting candidiasis
- •Chemotherapy induced oral mucositis with resulting candidiasis
- •Oral mucositis due to being immunocompromised with resulting candidiasis
- •Stomatitis due to other causes with resulting candidiasis
- •Currently have mild to moderate mucositis
排除标准
- •under the age of 18
- •pregnant or breastfeeding
- •inability to use an oral rinse
- •hypersensitivity to Aloe Vera and/or Silver
- •whose candida rinse culture was performed greater than 10 days prior to study entry.
- •has any sort of removable dental appliance
- •with previous or current history of any cancer of the oral cavity
- •who received therapy for candidiasis within the past 30 days
- •who used antifungal medication in the last 30 days
- •who has severe to life threatening oral muositis (Grade III-IV) oral mucositis
- •with impaired renal or hepatic function
- •receiving high dose chemotherapy and total body irradiation in preparation for Hemopoietic Stem Cell Transplant (HSCT) or Concomitant use of Kepivance® (palifermin or rhKGF)
研究组 & 干预措施
silver citrate complex and acemannan
This is a single arm open pilot trial. All participants will receive study drug.
干预措施: silver citrate complex and acemannan (Drug)
结局指标
主要结局
Clinical cure as demonstrated by change and reduction from baseline in typical candida lesions and a negative candida rinse culture
时间窗: Days 1(Baseline), 3, 7 and 14
Rinse culture will be taken on Days 1, 7 and 14 to quantify Candidal Colony Forming Units and observational assessment will be done at study entry, Day 1, Days 3, 7, 14 using the WHO grading scale for response evaluation.
次要结局
- Reduction in Pain(Days 1, 3, 7, 14)