Systemic Absorption of Dexamethasone Oral Rinse in Patients With Oral Lichen Planus
Key facts
- Who runs it
- Tufts University
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Phase
- Early phase 1
- Started
- 1 May 2025
- Expected to end
- 1 Sept 2027
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- dexamethasone oral rinse
- Record updated
- 14 May 2025
- Why it stopped
- Study protocol changed to be a retrospective exempt review project.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- History of advanced kidney, liver disease, or systemic fungal infection. 5. Corticosteroids hypersensitivity. 6. Active oral candidiasis 7. Patients on blood thinners medication ,anemic or suffer from bleeding disorders
- 1 . Under 18 years old 2. Pregnant women 3. Recent history (< than one month) of exposure to topical or systemic corticosteroids
Where in United States
- Tufts University School of Dental MedicineBoston, United States
About the trial
What the trial wants to find out
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).
The 3 groups in the trial
- Investigative group- Those with OLPTreatment being tested
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.
Treatment: dexamethasone oral rinse
- Control 1 - 5 minute rinseExisting treatment, for comparison
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.
Treatment: dexamethasone oral rinse
- Control 2- 2 minute rinseExisting treatment, for comparison
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.
Treatment: dexamethasone oral rinse
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 14 May 2025