Dexamethasone Oral Rinse for Oral Lichen Planus

Recruiting in Palo Alto (17 mi)

Overseen byVidya Sankar, DMD, MHS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Tufts University

No Placebo Group

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).

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

See 2 more

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.

See 4 more

Treatment Details

Interventions

Dexamethasone Oral Rinse (Corticosteroid)

Trial OverviewThe 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

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.