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Corticosteroid

Dexamethasone Oral Rinse for Oral Lichen Planus

Phase < 1

Waitlist Available

Led By Vidya Sankar, DMD, MHS

Research Sponsored by Tufts University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Over 18 years old

Be older than 18 years old

Must not have

Under 18 years old

Recent history (< than one month) of exposure to topical or systemic corticosteroids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 hours per subject

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to measure how much of a standard dose of dexamethasone oral rinse is absorbed by patients with oral lichen planus or lichenoid reactions, as well as healthy individuals

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not detailed here, but generally, dexamethasone can cause dry mouth, increased thirst, altered taste sensation, and possible systemic effects if absorbed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I have used corticosteroids in the last month.

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

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I currently have a fungal infection in my mouth.

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I am on blood thinners, have anemia, or a bleeding disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 hours per subject

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 hours per subject

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours per subject for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Systemic absorption of a standard dose of dexamethasone oral rinse

Secondary study objectives

Assessment of correlation between the amount of systemic absorption and the severity of the oral mucosal disorder

Other study objectives

Length of rinsing impact on systemic absorption

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Investigative group- Those with OLPExperimental Treatment1 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 rinseActive Control1 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 rinseActive Control1 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.

0 / 6Eligibility criteria met