Oral Lichenoid Reaction, Oral Lichen Planus
Conditions
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).
Interventions
DRUGdexamethasone 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.
Sponsors
Tufts University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of rinsing impact on systemic absorption | 2 hours per subject | If there is systemic absorption, does it differ based on length of time of rinsing? This is for those in the control group who will be rinsing for either 2 minutes or 5 minutes. The evaluation is if there is varying amounts of the rinse detected in the blood after the various blood draws. |
Countries
United States
Outcome results
None listed