An Early Phase 1 interventional study of dexamethasone oral rinse in Oral Lichen Planus and Oral Lichenoid Reaction, sponsored by Tufts University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by Tufts University · Early Phase 1, Interventional, and Treatment
Among 13 studies in Lichen Planus, Oral with a site in United States — none open to participants now, 1 under way, none of them phase 3. Lichen Planus, Oral · United States.
Among the 13 studies in Lichen Planus, Oral with a site in United States, this one is the 12th largest by enrollment of the 12 interventional ones that give a count, is the only one that started in 2025, is the only one in phase 1, and was the 13th registered.
142 studies on the registry are indexed under Lichen Planus, Oral; 27 are open to participants now.
Browse Lichen Planus, Oral studies →None of the 13 studies in Lichen Planus, Oral with a site in United States is open now. The open studies under Lichen Planus, Oral, anywhere →
Of the 14 Lichen Planus, Oral studies recruiting now, 10 (71%) set no upper age limit and 2 (14%) stop at 75 or younger; 3 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
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13 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 11 · Phase 3 1
First in 2003; this study’s year is marked. 1 started in 2025.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 24 across the 12 interventional studies. Of the 11 that completed or were terminated, 5 (45%) have results posted.
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2 of 13 have an industry lead sponsor. The 10 most frequent:
Tufts University is the lead sponsor of 228 studies on the registry; 23 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Tufts University has 1 study filed under Lichen Planus, Oral — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in Lichen Planus, Oral with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1 . Under 18 years old 2. Pregnant women 3. Recent history (\< than one month) of exposure to topical or systemic .
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: 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.
Drug: 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.
Drug: 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.
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
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
Length of rinsing impact on systemic absorption
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.
Time frame: 2 hours per subject
Plan to share: No
Start is estimated for May 2025; primary completion for Sep 2026, 16 months later.
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This study is withdrawn, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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