A Phase II Open-Label Trial of MucoLock™ Oral Rinse for the Treatment of Stomatitis Characterized by Oral Dysesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in Visual Analog Scale (VAS) pain score
研究概览
简要总结
The purpose of this research is to test how well people can tolerate MucoLock™ as a treatment for mouth pain or burning sensation and how well it works to reduce mouth pain or burning sensation. Study participants will be asked to use MucoLock™ topical solution as a "swish and spit" solution (similar to mouthwash) three times per day for 5 minutes each time, for 28 days.
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
- •Age 18 years and older
- •Individuals with oral dysesthesia (worst VAS sensitivity/burning score ≥ 7 over the last week)
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Inability to comply with study instructions
- •Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements*
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.
- •Advanced kidney disease
- •Patients receiving antineoplastic therapy [e.g., tyrosine kinase inhibitors (TKIs), radiation] that could increase the risk of oral dysesthesia
- •Known altered mental status, encephalopathy, or cognition impairment
- •Known alcohol use disorder
- •Concomitant opioid therapy
- •Diagnosis of oral cancer currently undergoing therapy
- •Already using topical therapy for mouth pain (e.g., lidocaine, Magic mouthwash)*
- •Any opioid pain medication*
- •Treatment with another investigational drug or other intervention within 2 weeks. Patients will be recommended to stop previous medication for 2 weeks before starting the study treatment.
- •(asterisk) *Modifiable criteria, with a timeframe of 2 weeks for a washout period.
研究组 & 干预措施
MucoLock™ Topical Solution
MucoLock™ oral gel will be used as a "swish and spit" (similar to using mouthwash), 15 mL three times per day, for 5 minutes each time, for 28 days.
干预措施: MucoLock Oral Gel (Device)
结局指标
主要结局
Change in Visual Analog Scale (VAS) pain score
时间窗: 28 days
Pain will be assessed using the VAS with a score of 0 being no pain and 10 being worst possible pain. Pre- to post-treatment change in VAS pain score will be compared.
次要结局
- Change in Oral Health Impact Profile-14 (OHIP-14) total score(28 days)
- Change in Oral Health Impact Profile-14 (OHIP-14) score (dichotomized)(28 days)
- Incidence of adverse events by severity and relatedness(28 days)