Dexamethasone Solution for the Treatment of Oral Lichen Planus

May 17, 2021 updated by: Herve Y. Sroussi, D.M.D.,Ph.D., Brigham and Women's Hospital

Dexamethasone Solution and Dexamethasone in Mucolox™ for the Treatment of Oral Lichen Planus

The objective of this single center, 4-week, open label randomized, phase II study is to evaluate and characterize the tolerability and clinical effectiveness of dexamethasone 0.5mg/5ml solution in a mucoadhesive vehicle (Mucolox™) for the treatment of oral lichen planus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Potentially eligible subjects will be screened by one of the investigators by asking patients to rate their worst oral pain or pain score (0-10) over the previous week (see Appendix). Those answering with at least a score of "7" (1/10) and that meet all other eligibility requirements (see Section 3) will be eligible for enrollment. All patients will sign informed consent for study participation. Each study visit is anticipated to take approximately 45 minutes.

Treatment will be administered on an outpatient basis. Study medication will be prescribed by authorized study staff physicians at no expense for the patient.

Subjects will be evaluated clinically at baseline before starting treatment and at the end of the four-week period, for a total of two visits. Comprehensive subjective and objective data will be collected and intraoral photographs will be obtained. Oral mucosal disease will be evaluated using both patient reported (questions/visual analog scales) and clinician assessed measures.

Subjects will be prescribed compound dexamethasone 0.5mg/5ml solution in Mucolox™ (ARM A) or dexamethasone 0.5mg/5ml solution only (ARM B). All subjects will also receive a prescription for fluconazole 200 mg tablets once-a-week as prophylactic antifungal therapy. Any subjects that are already taking an antifungal oral medication at the time of the study enrollment will continue their prescribed medication and will not need to take the additional weekly fluconazole dose. Subjects will return for evaluation after four weeks at which time the study end-points will be assessed.

If there is worsening of oral lichen planus that requires initiation of new immunomodulatory medications (systemic or topical), patients will remain on treatment, but will be regarded as unevaluable for the primary endpoint.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02120
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 years and older.
  • Patients with symptomatic oral lichen planus (worst VAS sensitivity score ≥ 7 over the last week).

Exclusion Criteria:

  • Patients already on topical or systemic steroids.
  • Inability to comply with study instructions.
  • Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
  • VAS sensitivity score < 7.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone solution
Dexamethasone 0.5 mg/mL, 5ml TID for 4 weeks
Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate
Other Names:
  • Decadron Elixir
Active Comparator: Dexamethasone solution in Mucolox™
Compounded dexamethasone 0.5 mg/mL in Mucolox™, 5ml TID for 4 weeks
Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate
Other Names:
  • Decadron Elixir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oral Sensitivity
Time Frame: 4 weeks after the start of the trial

Subjects scored their worse sensitivity while eating over the past week. This score is substracted from their initial reported sensitivity at baseline.

Reduction in oral symptoms of the worst sensitivity experienced in the past week on an 11 point scale (visual analogue scale 0-10). O signifies no sensitivity; 10 maximum sensitivity substracted from the same score collected at baseline before the treatment was initiated.

4 weeks after the start of the trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2017

Primary Completion (Actual)

December 19, 2019

Study Completion (Actual)

December 20, 2019

Study Registration Dates

First Submitted

July 26, 2016

First Submitted That Met QC Criteria

July 29, 2016

First Posted (Estimate)

August 1, 2016

Study Record Updates

Last Update Posted (Actual)

June 14, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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 Lichen Planus

Clinical Trials on Dexamethasone

3
Subscribe