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

Early Phase 1

Not yet recruiting

• Conditions: Oral Lichen Planus; Oral Lichenoid Reaction
• Interventions: Drug: dexamethasone oral rinse

• Registration Number: NCT06428630
• Lead Sponsor: Tufts University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-20
• Study First Submitted QC: 2024-05-20
• Study First Posted: 2024-05-24
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-31
• Study Start: 2024-09-01
• Primary Completion: 2026-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control 2- 2 minute rinse	dexamethasone oral rinse	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.
Investigative group- Those with OLP	dexamethasone oral rinse	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.
Control 1 - 5 minute rinse	dexamethasone oral rinse	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.

Primary Outcome Measures

Name	Time	Method
Systemic absorption of a standard dose of dexamethasone oral rinse	2 hours per subject	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of correlation between the amount of systemic absorption and the severity of the oral mucosal disorder	2 hours per subject	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.

Trial Locations

Locations (1)

Tufts University School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States