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

NCT06428630 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: STUDY00004549
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Oral Lichen Planus; Oral Lichenoid Reaction

Outcome Measures

Primary Outcomes (1)

• 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.

  2 hours per subject

Secondary Outcomes (1)

• Assessment of correlation between the amount of systemic absorption and the severity of the oral mucosal disorder

  2 hours per subject

Other Outcomes (1)

• Length of rinsing impact on systemic absorption

  2 hours per subject

Study Arms (3)

Investigative group- Those with OLP

EXPERIMENTAL

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

Control 1 - 5 minute rinse

ACTIVE COMPARATOR

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

Control 2- 2 minute rinse

ACTIVE COMPARATOR

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

Interventions

dexamethasone oral rinse DRUG

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old
• Non-pregnant
• 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
• 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
• Experimental group is clinically diagnosed with OLP/OLR
• Controls must have no history of OLP/OLR

You may not qualify if:

• Under 18 years old 2. Pregnant women 3. Recent history (\< than one month) of exposure to topical or systemic corticosteroids.
• \. 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

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

Related Publications (11)

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  PMID: 29055500 BACKGROUND

• Meikle AW, Lagerquist LG, Tyler FH. A plasma dexamethasone radioimmunoassay. Steroids. 1973 Aug;22(2):193-202. doi: 10.1016/0039-128x(73)90085-8. No abstract available.

  PMID: 4795381 BACKGROUND

• Spoorenberg SM, Deneer VH, Grutters JC, Pulles AE, Voorn GP, Rijkers GT, Bos WJ, van de Garde EM. Pharmacokinetics of oral vs. intravenous dexamethasone in patients hospitalized with community-acquired pneumonia. Br J Clin Pharmacol. 2014 Jul;78(1):78-83. doi: 10.1111/bcp.12295.

  PMID: 24400953 BACKGROUND

• Jarvinen A, Granander M, Laine T, Viitanen A. Effect of dose on the absorption of estradiol from a transdermal gel. Maturitas. 2000 Apr 28;35(1):51-6. doi: 10.1016/s0378-5122(00)00101-8.

  PMID: 10802400 BACKGROUND

• Aalto-Korte K, Turpeinen M. Quantifying systemic absorption of topical hydrocortisone in erythroderma. Br J Dermatol. 1995 Sep;133(3):403-8. doi: 10.1111/j.1365-2133.1995.tb02668.x.

  PMID: 8546995 BACKGROUND

• Georgaki M, Piperi E, Theofilou VI, Pettas E, Stoufi E, Nikitakis NG. A randomized clinical trial of topical dexamethasone vs. cyclosporine treatment for oral lichen planus. Med Oral Patol Oral Cir Bucal. 2022 Mar 1;27(2):e113-e124. doi: 10.4317/medoral.25040.

  PMID: 34564686 BACKGROUND

• Joly P, Roujeau JC, Benichou J, Picard C, Dreno B, Delaporte E, Vaillant L, D'Incan M, Plantin P, Bedane C, Young P, Bernard P; Bullous Diseases French Study Group. A comparison of oral and topical corticosteroids in patients with bullous pemphigoid. N Engl J Med. 2002 Jan 31;346(5):321-7. doi: 10.1056/NEJMoa011592.

  PMID: 11821508 BACKGROUND

• Varoni EM, Molteni A, Sardella A, Carrassi A, Di Candia D, Gigli F, Lodi F, Lodi G. Pharmacokinetics study about topical clobetasol on oral mucosa. J Oral Pathol Med. 2012 Mar;41(3):255-60. doi: 10.1111/j.1600-0714.2011.01087.x. Epub 2011 Sep 22.

  PMID: 21950548 BACKGROUND

• Sankar V, Hearnden V, Hull K, Juras DV, Greenberg MS, Kerr AR, Lockhart PB, Patton LL, Porter S, Thornhill M. Local drug delivery for oral mucosal diseases: challenges and opportunities. Oral Dis. 2011 Apr;17 Suppl 1:73-84. doi: 10.1111/j.1601-0825.2011.01793.x.

  PMID: 21382140 BACKGROUND

• Plemons JM, Rees TD, Zachariah NY. Absorption of a topical steroid and evaluation of adrenal suppression in patients with erosive lichen planus. Oral Surg Oral Med Oral Pathol. 1990 Jun;69(6):688-93. doi: 10.1016/0030-4220(90)90349-w.

  PMID: 2356081 BACKGROUND

• Einarsdottir MJ, Bankvall M, Robledo-Sierra J, Rodstrom PO, Bergthorsdottir R, Trimpou P, Hasseus B, Ragnarsson O. Topical clobetasol treatment for oral lichen planus can cause adrenal insufficiency. Oral Dis. 2024 Apr;30(3):1304-1312. doi: 10.1111/odi.14588. Epub 2023 Apr 27.

  PMID: 37103329 BACKGROUND

MeSH Terms

Conditions

Lichen Planus, Oral

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Vidya Sankar, DMD, MHS

  Tufts University School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)