Dexamethasone Oral Rinse for Oral Lichen Planus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an oral rinse containing dexamethasone to measure its absorption into the body. The focus is on individuals with oral lichen planus (OLP) or oral lichenoid reactions (OLR), which cause painful mouth sores. The trial includes different groups to compare the rinse's effects on those with and without these conditions. Individuals who have recently noticed mouth sores and have not used certain medications for a month might be suitable candidates. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial requires that you have not used topical or systemic corticosteroids for at least one month before participating. If you are taking corticosteroids, you will need to stop them for a month before joining the trial.
Is there any evidence suggesting that dexamethasone oral rinse is likely to be safe for humans?
Research shows that using dexamethasone as a mouth rinse is generally safe, though some side effects might occur. Studies have found that while most people tolerate it well, about 11-47% of those using it for oral lichen planus (OLP) may develop a yeast infection called secondary candidiasis. Other possible side effects include a bad taste, dry mouth, and occasionally thinning of the mouth lining. These effects can vary, but they are important to consider when thinking about joining a trial for this treatment.12345
Why do researchers think this study treatment might be promising for oral lichen planus?
Researchers are excited about using dexamethasone oral rinse for oral lichen planus because it offers a targeted, topical approach to treatment. Unlike standard options like systemic corticosteroids or topical corticosteroid gels and ointments, this rinse confines the medication to the oral cavity without being swallowed, potentially reducing systemic side effects. Additionally, the rinse is easy to use and may provide quicker relief by directly soothing the affected areas. This innovative delivery method could mark a significant improvement in comfort and safety for patients dealing with this chronic condition.
What evidence suggests that dexamethasone oral rinse could be an effective treatment for oral lichen planus?
Research has shown that a dexamethasone mouth rinse can ease the symptoms of oral lichen planus (OLP). In one study, most patients noticed improvements within a year, although some developed new sores. Another study found that 75% of patients felt much better after using the rinse. Compared to other treatments, dexamethasone proved very effective in reducing OLP symptoms. This trial will evaluate the effectiveness of different durations of dexamethasone oral rinse application. These findings suggest that a dexamethasone mouth rinse could be a promising way to manage OLP symptoms.23467
Who Is on the Research Team?
Vidya Sankar, DMD, MHS
Principal Investigator
Tufts University School of Dental Medicine
Are You a Good Fit for This Trial?
This trial is for individuals with oral lichen planus or lichenoid reactions, and also includes healthy subjects as a control group. The main goal is to understand how much of the dexamethasone rinse gets into the body from the mouth.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants apply dexamethasone oral rinse for 2 or 5 minutes, followed by blood draws to measure systemic absorption
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone Oral Rinse
Trial Overview
The study focuses on measuring systemic absorption of dexamethasone oral rinse in patients with symptomatic OLP/OLR compared to healthy controls after using a standard dose.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tufts University
Lead Sponsor
Published Research Related to This Trial
Citations
Factors affecting treatment outcomes in patients with oral ...
Improvements were observed within 1 year after dexamethasone treatment in most cases, and 17.7% of patients had a new OLP lesion after treatment ...
The effectiveness of topical forms of dexamethasone in ...
The goal of this systematic review was to assess the efficacy of dexamethasone compared to other treatments in oral lichen planus (OLP).
A randomized clinical trial of topical dexamethasone vs. ...
Taken together, these results suggest that, in terms of effectiveness, both topical dexamethasone and cyclosporine result in significant improvement in clinical ...
NCT00111072 | Dexamethasone to Treat Oral Lichen Planus
This study will evaluate the effectiveness of dexamethasone 0.01% solution in treating pain associated with oral lichen planus, a chronic disease that causes ...
The Effect of Mouthrinse with 0.05% Dexamethasone ...
In total, 20 patients were enrolled in this study, wherein all were noted to show improved symptoms of OLP. Fifteen patients (75%) had a qualitative change in ...
NCT02850601 Dexamethasone Solution for the Treatment ...
Use of topical steroids for oral lichen planus may lead to the development of secondary candidiasis in. 11-47% of patients, which requires ...
Pharmacological Treatment of Oral Lichen Planus
The main side effects of topical corticosteroids include secondary candidiasis, mucosal atrophy, bad taste, oral dryness, and dyspepsia. 2 ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.