Rebamipide for management of methotrexate-induced oral ulcers: a three-arm randomized clinical trial

Abstract Objectives This RCT aimed to evaluate the effect of topical Rebamipide (regular and nanoparticulated) in comparison to topical Clobetasol propionate in the management of methotrexate-induced oral ulcers in rheumatoid arthritis patients. Materials and methods Patients were divided randomly into three parallel arms: 1% Rebamipide; 1% nanoparticulated Rebamipide, Clobetasol propionate. The outcome measures included WHO oral mucositis grading, pain (NRS), ulcer size, and healing time. The data was analyzed for any statistical significance. Results Intragroup comparisons of mucositis grade improvement and pain reduction revealed significant differences in all the groups. All intergroup comparisons demonstrated non-significant difference, yet nanoparticulated Rebamipide was leading, and all group participants achieved complete healing earlier than the other groups. Conclusion Rebamipide, regular and nanoparticulated forms, showed comparable results to potent Corticosteroid, Clobetasol propionate in management of the oral ulcers. Clinical relevance Rebamipide is an efficient promising alternative modality for management of methotrexate-induced oral ulcers in rheumatoid arthritis patients.