- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06428630
Systemic Absorption of Dexamethasone Oral Rinse in Patients With Oral Lichen Planus
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Ann-Marie Billig
- Phone Number: 6176363931
- Email: dentalresearchadministration@tufts.edu
Study Contact Backup
- Name: Vidya Sankar, DMD, MHS
- Phone Number: 617-636-3932
- Email: vidya.sankar@tufts.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Tufts University School of Dental Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Investigative group- Those with OLP
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.
|
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. |
Active Comparator: Control 1 - 5 minute 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.
|
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. |
Active Comparator: Control 2- 2 minute 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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systemic absorption of a standard dose of dexamethasone oral rinse
Time Frame: 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.
|
2 hours per subject
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of correlation between the amount of systemic absorption and the severity of the oral mucosal disorder
Time Frame: 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.
|
2 hours per subject
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of rinsing impact on systemic absorption
Time Frame: 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.
|
2 hours per subject
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vidya Sankar, DMD, MHS, Tufts University School of Dental Medicine
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Skin Diseases, Papulosquamous
- Lichen Planus, Oral
- Lichen Planus
- Lichenoid Eruptions
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- STUDY00004549
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Oral Lichen Planus
-
Cairo UniversityUnknownPatients With Oral Lichen PlanusEgypt
-
Alexandria UniversityCompletedEvaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen PlanusErosive Oral Lichen PlanusEgypt
-
Pia Lopez JornetCompletedOral Lichen Planus | Oral Lichen Planus Related StressSpain
-
Mashhad University of Medical SciencesUnknownTherapeutic Effect of Quercetin and the Current Treatment of Erosive and Atrophic Oral Lichen PlanusErosive Oral Lichen Planus | Atrophic Oral Lichen PlanusIran, Islamic Republic of
-
Panineeya Mahavidyalaya Institute of Dental Sciences...CompletedOral Lichen Planus Related StressIndia
-
Cairo UniversityCompletedErosive Oral Lichen PlanusEgypt
-
University of North Carolina, Chapel HillEli Lilly and CompanyRecruitingLichen Planus, Oral | Oral Lichen Planus | Lichen Planus, MucosalUnited States
-
Nourhan M.AlyAlexandria UniversityCompleted
-
Mashhad University of Medical SciencesCompleted
Clinical Trials on dexamethasone oral rinse
-
Sunstar AmericasCompleted
-
Biomedical Development CorporationNational Heart, Lung, and Blood Institute (NHLBI); University of KentuckyUnknownGingivitis | Investigation of Biological Markers of InflammationUnited States
-
Parion SciencesCompletedSjogren's Syndrome | XerostomiaUnited States
-
Biomedical Development CorporationNational Institute of Dental and Craniofacial Research (NIDCR); University...CompletedCandidiasis | Candidiasis, Oral | ThrushUnited States
-
Rowpar Pharmaceuticals, Inc.University Health Resources GroupCompletedOral Malodor
-
Biomedical Development CorporationNational Heart, Lung, and Blood Institute (NHLBI); University of TexasCompleted
-
Biomedical Development CorporationNational Institute of Nursing Research (NINR)Completed
-
Universidad de GranadaUniversity of PalermoTerminated
-
GlaxoSmithKlineCompletedDentin SensitivityUnited States
-
3MCompleted