Clinical trial NCT06428630: Systemic Absorption of Dexamethasone Oral Rinse in Patients With Oral Lichen Planus
Official title: Systemic Absorption of Dexamethasone Oral Rinse in Patients With Oral Lichen Planus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Oral Lichen Planus
Oral Lichenoid Reaction
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigative group: Subjects with symptomatic oral lichen planus (OLP) or oral lichenoid reactions (OLR) Control Group: Those otherwise healthy

Both 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.
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Systemic absorption of a standard dose of dexamethasone oral rinse
timeFrame: 2 hours per subject
Secondary outcomes:
measure: Assessment of correlation between the amount of systemic absorption and the severity of the oral mucosal disorder
timeFrame: 2 hours per subject
Other outcomes:
measure: Length of rinsing impact on systemic absorption
timeFrame: 2 hours per subject
Locations:
city: Boston
country: United States
facility: Tufts University School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Tufts University School of Dental Medicine
name: Vidya Sankar, DMD, MHS
role: PRINCIPAL_INVESTIGATOR
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