Objective: The objective of this single-center, open-label, randomized, phase II study was to evaluate the safety and efficacy of dexamethasone 0.1 mg/mL solution in Mucolox (arm A) compared with dexamethasone 0.1 mg/mL solution alone (arm B) for treatment of oral lichen planus (OLP).

Study design: Patients with clinical OLP and visual analog scale (VAS) sensitivity scores 7 or greater were randomized to arm A or B. Reticulation/erythema/ulcer (REU) scores, VAS for sensitivity and the Chronic Oral Mucosal Diseases Questionnaire (COMDQ) were completed at the baseline and the end of treatment (4 weeks). Differences were assessed by using Wilcoxon's rank-sum test.

Results: Twenty-four patients (females n = 21; median age 64.5 years; range 45-80 years) were randomly assigned to arm A or B. Four patients were excluded. Dexamethasone with or without the addition of Mucolox was effective at reducing the REU score, but the Mucolox-containing solution was relatively more effective (6-point reduction vs 4.3-point reduction; P < .001). There was significant improvement in the total COMDQ score in both arms (mean change 1.8 [arm A] vs 2.5 [arm B]). There were no differences in compliance between the 2 study arms (P = .58).

Conclusions: Dexamethasone 0.1 mg/mL solution in Mucolox was more effective for the management of OLP compared with dexamethasone 0.1 mg/mL solution alone. Larger studies are needed to confirm these preliminary findings.