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.
Full Title of Study: “Dexamethasone Solution and Dexamethasone in Mucolox™ for the Treatment of Oral Lichen Planus”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 19, 2019
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.
- Drug: Dexamethasone
- Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate
Arms, Groups and Cohorts
- Experimental: Dexamethasone solution
- Dexamethasone 0.5 mg/mL, 5ml TID for 4 weeks
- Active Comparator: Dexamethasone solution in Mucolox™
- Compounded dexamethasone 0.5 mg/mL in Mucolox™, 5ml TID for 4 weeks
Clinical Trial Outcome Measures
- Reduction in oral symptoms on a VAS
- Time Frame: 4 weeks
- Clinical improvement (REU score)
- Time Frame: 4 weeks
- In order to evaluate the clinical improvement in clinician-reported outcome measures for oral lichen planus, REU scores within the compound dexamethasone solution in Mucolox™ group (Arm A) will be compared to that in the dexamethasone solution only group (Arm B). The REU scores will be summarized descriptively for each arm at pre-treatment, post-treatment, and pre-to-post treatment change. The pre-to-post treatment change will be compared between the arms using either student’s t-test or Mann-Whitney test, depending on the distribution of the data.
- Chronic Oral Mucosal Diseases Quality of Life Questionnaire
- Time Frame: 4 weeks
- Another secondary objective include the evaluation of the oral health related quality of life using the 24-item Chronic Oral Mucosal Diseases Quality of Life Questionnaire. The COMDQLQ scores will be summarized descriptively for each arm at pre-treatment, post-treatment, and pre-to-post treatment change. The pre-to-post treatment change for each item and for all items combined will be assessed within each arm using either paired t test or Wilcoxon-signed-rank test depending on its distribution. In addition, each question will be dichotomized and classified as ‘response’ if the answer is ‘not at all’, or ‘slightly’ to a question such as “how isolated do you feel as a result of this oral condition”, and pre-to-post treatment improvement will be assessed using McNemar’s test within each arm.
Participating in This Clinical Trial
- Age 18 years and older.
- Patients with symptomatic oral lichen planus (worst VAS sensitivity score ≥ 7 over the last week).
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Brigham and Women’s Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Herve Y. Sroussi, D.M.D.,Ph.D., Oral Medicine Attending – Brigham and Women’s Hospital
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