Evaluation of topical human platelet lysate versus topical clobetasol in management of methotrexate-induced oral ulceration in rheumatoid arthritis patients: Randomized-controlled clinical trial.

BACKGROUND: There is no mainstay protocol for management of Methotrexate-induced oral ulcers; commonly used protocols are cessation of Methotrexate, folic acid treatment, corticosteroids or combination. A new era of oral ulcers management is represented by platelet concentrates. The current study assessed the effect of topical human platelet lysate compared to topical Clobetasol Propionate in management of methotrexate-induced oral ulceration in rheumatoid arthritis patients. METHODS: This randomized controlled clinical trial include 30 patients in two parallel groups (intervention - human platelet lysate, control - Clobetasol Propionate), with allocation ratio 1:1. Outcome measures were pain intensity using numerical rating scale, WHO scale for oral mucositis, measuring size of the largest ulcer and total number of oral ulcers. RESULTS: A statistically significant difference was detected between HPL and Clobetasol groups on comparing numerical rating scale, WHO mucositis scale, size and total number of oral ulcers throughout all visits. A considerable quick pain reduction and clinical improvement were noticed in HPL group compared to Clobetasol. CONCLUSION: Human platelet lysate has superior effect when compared to one of the most potent topical corticosteroids, Clobetasol Propionate, in reducing pain and clinical signs of Methotrexate-induced oral ulcers in patients with rheumatoid arthritis.