Clinical trial

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

Name

STUDY00004549

Description

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).

Trial arms

Trial start

2024-09-01

Estimated PCD

2026-09-01

Trial end

2027-09-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

dexamethasone oral rinse

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.

Arms:

Control 1 - 5 minute rinse, Control 2- 2 minute rinse, Investigative group- Those with OLP

Size

Primary endpoint

Systemic absorption of a standard dose of dexamethasone oral rinse

2 hours per subject

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Investigative group: Subjects with symptomatic oral lichen planus (OLP) or oral lichenoid reactions (OLR) Control Group: Those otherwise healthy\n\nBoth groups will receive the same intervention. 5 of the control subjects will swish for 5 minutes, 5 of the control subjects will swish for 2 minutes.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

Updated at

2024-05-31

1 organization

1 product

2 indications

Organization

Tufts University

Product

Dexamethasone

Indication

Oral Lichen Planus

Indication

Oral Lichenoid Reaction