Dexamethasone solution and dexamethasone in Mucolox for the treatment of oral lichen planus: a preliminary report on findings

Abstract

Objectives Topical use of steroids, such as dexamethasone rinses, is the mainstay of therapy for oral lichen planus (OLP).Treatment is challenging because it requires multiple daily applications of the solution, which is easily washed away when it comes in contact with saliva and foods or drinks. Mucolox is a mucosal delivery system that prolongs the time of contact with the mucosa, potentially improving the efficacy of topical steroid rinses. The objective of this single-center, open-label, randomized, phase II study was to evaluate the safety and efficacy of dexamethasone solution (standard of care) in Mucolox (group A) compared with dexamethasone solution alone (group B) for the treatment of OLP. The primary outcome measure was to detect changes in each subject's sensitivity scores (0–10) evaluated at baseline and after 4 weeks of treatment. Study Design Patients with clinical OLP and a visual analogue scale (VAS) sensitivity score of 7 or greater were randomized to group A or group B. REU (Reticulation/keratosis, erythema, and ulceration) scoring, VAS for sensitivity, and Chronic Oral Mucosal Diseases Questionnaire (COMDQ) were completed at baseline and at end of treatment (4 weeks). The sample size was calculated at 80% power and 2-sided alpha of 0.05 to detect at difference of 2.0 points on an 11-point scale. Differences were assessed by using Wilcoxon's rank-sum test. Results Sixteen patients (15 females, 1 male (median age 64.5 years; range 45–76 years) were randomly assigned to group A or group B (8 patients each). Two patients were excluded because they did not return for follow-up (1 from group A and 1 from group B [voluntary withdrawal]). Dexamethasone solution in Mucolox was significantly more effective in improving self-reported oral sensitivity compared with dexamethasone solution only (6-point reduction vs 4-point reduction; P Conclusions Topical dexamethasone solution in Mucolox appears to be more effective for managing symptoms in patients with OLP compared with dexamethasone solution only. Larger studies are necessary to confirm these preliminary findings.