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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

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.

What data supports the effectiveness of the drug Dexamethasone Oral Rinse for treating oral lichen planus?

The research highlights that corticosteroids, like dexamethasone, are commonly used to treat oral lichen planus due to their ability to reduce inflammation. Although the study focused on creating a more pleasant formulation, it implies that dexamethasone is effective in managing symptoms of oral lichen planus. ^{1 2 3 4 5}

Is dexamethasone oral rinse safe for humans?

A study evaluated the safety of dexamethasone 0.1 mg/mL solution for oral lichen planus, suggesting it has been tested for safety in humans. ^{1 4 5 6 7}

How is the drug Dexamethasone Oral Rinse unique for treating oral lichen planus?

Dexamethasone Oral Rinse is unique because it offers a more pleasant and effective formulation compared to the traditional method of crushing dexamethasone tablets and mixing them with water, which is often bitter and gritty. This new formulation aims to improve patient compliance by being more esthetically pleasing and easier to use. ^{1 4 5 6 8}

Research Team

Vidya Sankar, DMD, MHS

Principal Investigator

Tufts University School of Dental Medicine

Eligibility Criteria

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.

I have used corticosteroids in the last month.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Comparison between self-formulation and compounded-formulation dexamethasone mouth rinse for oral lichen planus: a pilot, randomized, cross-over trial. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Oral bullous lichen planus: Case report and review of management. [2021]

3. India pubmed.ncbi.nlm.nih.gov

A randomized triple-blind clinical trial to compare the effectiveness of topical triamcinolone acetonate (0.1%), clobetasol propionate (0.05%), and tacrolimus orabase (0.03%) in the management of oral lichen planus. [2020]

4. Denmark pubmed.ncbi.nlm.nih.gov

Triamcinolone acetonide mouth rinses for treatment of erosive oral lichen planus: efficacy and risk of fungal over-infection. [2013]

5. China pubmed.ncbi.nlm.nih.gov

[A randomized single-blind controlled clinical trial of tacrolimus mouth rinse on erosive oral lichen planus]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Dexamethasone solution and dexamethasone in Mucolox for the treatment of oral lichen planus: a preliminary study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Formulation and efficacy of triamcinolone acetonide mouthwash for treating oral lichen planus. [2022]

8. China pubmed.ncbi.nlm.nih.gov

[Effects of glucocorticoids on T helper cells balance in oral lichen planus]. [2013]