Systemic Absorption of Dexamethasone Oral Rinse in Patients With Oral Lichen Planus
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Systemic absorption of a standard dose of dexamethasone oral rinse
研究概览
简要总结
The objective of this study is to see the amount of systemic absorption of a standard dose of dexamethasone oral rinse for patients with symptomatic oral lichen planus (OLP) or oral lichenoid reactions (OLR) and healthy subjects (those who do not have OLP or OLR aka the control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Over 18 years old
- •Non-pregnant
- •Newly diagnosed subjects with OLP/OLR. Definition of 'newly" in this case : new patient with complaint regarding oral erosions and ulceration, and diagnose clinically with OLP or OLR for the first time
- •Those not exposed to topical or systemic corticosteroids for the previous 1 month. Meaning, those willing to not take this OLP/OLR treatment for 1 month before their visit
- •Experimental group is clinically diagnosed with OLP/OLR
- •Controls must have no history of OLP/OLR
排除标准
- •1 . Under 18 years old
- •Pregnant women
- •Recent history (< than one month) of exposure to topical or systemic corticosteroids.
- •History of advanced kidney, liver disease, or systemic fungal infection.
- •Corticosteroids hypersensitivity.
- •Active oral candidiasis
- •Patients on blood thinners medication ,anemic or suffer from bleeding disorders
研究组 & 干预措施
Investigative group- Those with OLP
The investigative will apply the dexamethasone oral rinse 0.5 mg/5ml treatment. The oral rinse is considered a topical rinse because it is confined to the oral cavity (topical) and not swallowed. Subjects will be reminded by the study team via a phone call a few days before their visit that they must not drink water or eat at least 60 min before their visit. Once we get to the stage of the rinse, we will first their oral cavity with gauze. Then, we will instruct the subject to Rinse their mouth with 0.5mg/5ml dexamethasone for 2 min, then spit into a provided plastic cup the oral rinse. This will then be discarded down the drain.
干预措施: dexamethasone oral rinse (Drug)
Control 1 - 5 minute rinse
The first control group will apply the dexamethasone oral rinse 0.5 mg/5ml treatment. The oral rinse is considered a topical rinse because it is confined to the oral cavity (topical) and not swallowed. Subjects will be reminded by the study team via a phone call a few days before their visit that they must not drink water or eat at least 60 min before their visit. Once we get to the stage of the rinse, we will first their oral cavity with gauze. Then, we will instruct the subject to Rinse their mouth with 0.5mg/5ml dexamethasone for 5 min, then spit into a provided plastic cup the oral rinse. This will then be discarded down the drain.
干预措施: dexamethasone oral rinse (Drug)
Control 2- 2 minute rinse
The second control group will apply the dexamethasone oral rinse 0.5 mg/5ml treatment. The oral rinse is considered a topical rinse because it is confined to the oral cavity (topical) and not swallowed. Subjects will be reminded by the study team via a phone call a few days before their visit that they must not drink water or eat at least 60 min before their visit. Once we get to the stage of the rinse, we will first their oral cavity with gauze. Then, we will instruct the subject to Rinse their mouth with 0.5mg/5ml dexamethasone for 2 min, then spit into a provided plastic cup the oral rinse. This will then be discarded down the drain.
干预措施: dexamethasone oral rinse (Drug)
结局指标
主要结局
Systemic absorption of a standard dose of dexamethasone oral rinse
时间窗: 2 hours per subject
To investigate the amount (level detected in blood), through blood draw, of how much dexamethasone oral rinse is absorbed in the blood stream over two hours.
次要结局
- Assessment of correlation between the amount of systemic absorption and the severity of the oral mucosal disorder(2 hours per subject)