Systemic Absorption of Dexamethasone Oral Rinse in Patients With Oral Lichen Planus

Tufts University

Status and phase: Begins enrollment this month; Early Phase 1

Conditions: Oral Lichen Planus; Oral Lichenoid Reaction

Treatments: Drug: dexamethasone oral rinse

Study type: Interventional

Funder types: Other

Identifiers

NCT06428630

STUDY00004549

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Over 18 years old
2. Non-pregnant
3. Newly diagnosed subjects with OLP/OLR. Definition of 'newly" in this case : new patient with complaint regarding oral erosions and ulceration, and diagnose clinically with OLP or OLR for the first time
4. Those not exposed to topical or systemic corticosteroids for the previous 1 month. Meaning, those willing to not take this OLP/OLR treatment for 1 month before their visit
5. Experimental group is clinically diagnosed with OLP/OLR
6. Controls must have no history of OLP/OLR

Exclusion criteria

1 . Under 18 years old 2. Pregnant women 3. Recent history (< than one month) of exposure to topical or systemic corticosteroids.

4. History of advanced kidney, liver disease, or systemic fungal infection. 5. Corticosteroids hypersensitivity. 6. Active oral candidiasis 7. Patients on blood thinners medication ,anemic or suffer from bleeding disorders

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Investigative group- Those with OLP

Experimental group

Description:

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.

Treatment:

Drug: dexamethasone oral rinse

Control 1 - 5 minute rinse

Active Comparator group

Description:

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.

Treatment:

Drug: dexamethasone oral rinse

Control 2- 2 minute rinse

Active Comparator group

Description:

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.

Treatment:

Drug: dexamethasone oral rinse