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

Oral Lichen Planus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06428630
• Other study ID #: STUDY00004549
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: September 1, 2024
• Est. completion date: September 1, 2027

Study information

• Verified date: May 2024
• Source: Tufts University
• Contact: Vidya Sankar, DMD, MHS
• Phone: 617-636-3932
• Email: vidya.sankar[@]tufts.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus
• Oral Lichenoid Reaction

Intervention

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.

Locations

Country	Name	City	State
United States	Tufts University School of Dental Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rice JB, White AG, Scarpati LM, Wan G, Nelson WW. Long-term Systemic Corticosteroid Exposure: A Systematic Literature Review. Clin Ther. 2017 Nov;39(11):2216-2229. doi: 10.1016/j.clinthera.2017.09.011. Epub 2017 Oct 19. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	2 hours per subject
Primary	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	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.	2 hours per subject