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

Early Phase 1WithdrawnNCT06428630

Tufts University

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Oral Lichen Planus Oral Lichenoid Reaction

Interventions

dexamethasone oral rinseDRUG

The study drug is FDA approved (NDC- 0054-3177) and will be used as it would be used in a standard of care setting. The rinse will be administered on the same therapeutic dose to OLP/OLR (0.5 mg/5ml of dexamethasone oral rinse once (rinse for 2 minutes or 5 minutes), then spit the excess into a cup. The oral rinse dexamethasone 0.5 mg/5ml will be used only on the subjects who participated in the study.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Systemic absorption of a standard dose of dexamethasone oral rinse

To investigate the amount (level detected in blood), through blood draw, of how much dexamethasone oral rinse is absorbed in the blood stream over two hours.

Time frame: 2 hours per subject

Secondary Outcomes

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

A clinical oral examination will be conducted for the REU scoring system this will determine what severity category they are in (what their REU score is out of 30 with 30 being most severe and 0 being mild lichen planus). The oral cavity will be examined based on REU scoring system to determine the subject belong to mild , moderate or severe group.

Time frame: 2 hours per subject

Data from ClinicalTrials.gov

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