Abstract

Evaluation of The Efficacy of Topically Applied Tacrolimus in the Treatment of Oral Ulcers in Behcet’s Disease

Author(s): Manal Mohamed Ahmed Hassanien

Objectives: Compare the clinical efficacy of topical oral Tacrolimus versus oral colchicine based on disease activity, pain and ulcer severity score in oral ulcer associated with BD.

Methodology: 40 BD cases (> 3 months underwent traditional treatment with persistent active oral ulceration). They were equally randomized into either group I (Colchicine and topically applied Tacrolimus), or whereas group II (Colchicine only). All participants were evaluated through based on Behcet's Disease Current Activity Form (BDCAF), Ulcer Severity Score (USS) and visual analog scale (VAS) pre-injection, and then re-evaluated post-injection at four-time points (15 days, 1st, 2nd, and 3rd months). Registered in clinicaltrials.gov under the number of (NCT05032248)

Results: VAS was significantly lower in group I after 2 weeks and 3 months than in group II. USS was significantly lower in group I after 3 months of follow up. BDCAF showed significant improvement in 3 months follow up within each group, while there was insignificant difference between both.

Conclusion: Topical Tacrolimus has been proved as to be a safe and effective adjunctive therapy in the management of oral ulcerations in BD.