Dexamethasone solution and dexamethasone in Mucolox™ for the treatment of oral inflammatory ulcerative diseases: A phase II randomized clinical trial

Abstract

AbstractBackgroundMucolox™ is a mucosal drug delivery system that prolongs the contact time between the oral mucosa and topical corticosteroids, potentially reducing the need for multiple applications daily. This study aimed to assess the clinical efficacy and tolerability of dexamethasone 0.5 mg/5 mL solution in Mucolox™ for the management of oral inflammatory ulcerative diseases.MethodsParticipants were randomly assigned to receive dexamethasone 0.5 mg/5 mL in Mucolox™ (Mucolox™ arm) or dexamethasone 0.5 mg/5 mL solution (standard arm) and instructed to swish/gargle for 5 min three times daily. Changes from pre‐ to posttreatment patient's sensitivity score (0–10 on a visual analog scale), reticulation/erythema/ulceration score, and oral health‐related quality of life were evaluated at baseline and at the end of the study period.ResultsTwenty nine patients (75% females) with a median age of 58 years (range 18–79) were enrolled and randomly allocated to the Mucolox™ or standard arm. One subject was excluded. Although statistically significant in both arms, the pre‐ to posttreatment sensitivity score reduction was higher in the Mucolox™ arm (6.3 vs. 4.4‐point reduction). Both arms showed a decrease in the reticulation/erythema/ulceration score between the two visits (7.2 vs. 4.7 [Mucolox™ arm]; 8.0 vs. 4.8 [standard arm]; p > 0.05). Mucolox™ in dexamethasone 0.5 mg/5 mL solution was better tolerated when taste and level of comfort were considered.ConclusionsBoth treatments were effective in the management of oral inflammatory ulcerative diseases. Dexamethasone 0.5 mg/5 mL in Mucolox™ was better tolerated and was slightly better in controlling patients' oral sensitivity. Larger studies are needed to confirm these findings in oral inflammatory ulcerative diseases patients.Trial Registration: ClinicalTrials.gov Identifier: NCT04540133.