Dexamethasone Oral Rinse for Oral Lichen Planus

Overseen By Ann-Marie Billig

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Tufts University

Must not be taking: Corticosteroids, Blood thinners

Disqualifiers: Pregnancy, Kidney disease, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 hours per subject

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. ^{1 2 3 4 5}

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. ^{2 3 4 6 7}

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

I have been diagnosed with oral lichen planus or oral lichenoid reactions.

Non-pregnant

Controls with no history of OLP/OLR

Exclusion Criteria

I am under 18 years old.

I have a history of severe kidney, liver disease, or fungal infection.

Corticosteroids hypersensitivity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants apply dexamethasone oral rinse for 2 or 5 minutes, followed by blood draws to measure systemic absorption

2 hours per subject

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

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?

Group I: Investigative group- Those with OLP Experimental Treatment 1 Intervention

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.

Group II: Control 1 - 5 minute rinse Active Control 1 Intervention

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.

Group III: Control 2- 2 minute rinse Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

Published Research Related to This Trial

Tacrolimus mouth rinse was found to be effective in reducing symptoms of erosive and ulcerative oral lichen planus (OLP), showing significant improvement in REU scores compared to dexamethasone after 4 weeks of treatment.

Although the overall effective rate was similar between tacrolimus and dexamethasone at 4 and 12 weeks, tacrolimus demonstrated quicker effects, suggesting it could be a valuable treatment option for OLP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A randomized single-blind controlled clinical trial of tacrolimus mouth rinse on erosive oral lichen planus]. Zuo, WX., Li, XY., Cai, GY., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6125672/

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 ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/odi.13966

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).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8898582/

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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00111072

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 ...

5. mdpi.com mdpi.com/2076-3417/11/14/6286

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 ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/01/NCT02850601/Prot_SAP_001.pdf

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 ...

7. journalomp.org journalomp.org/journal/view.html?doi=10.14476/jomp.2025.50.1.6

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 ...