EVALUATION OF THE EFFICACY OF TOPICALLY APPLIED TACROLIMUS IN THE TREATMENT OF ORAL ULCERS IN BEHCET’S DISEASE: A DOUBLE-BLIND PLACEBO CONTROLLED STUDY
Authors: Hassanien M et al. Egypt et al.
In this double-blind, placebo-controlled trial 40 patients with Behçet’s disease (BD) and persistent active oral ulcerations were equally randomized into group 1 (20 patients received oral colchicine plus topically applied tacrolimus) and group 2 (20 patients received oral colchicine plus placebo oral gel). All participants were evaluated based on Behçet’s disease current activity form (BDCAF), ulcer severity score (USS) and visual analogue scale (VAS) before treatment, and at four-time points post-treatment (15 days, 1st, 2nd, and 3rd months).
VAS was significantly lower in group 1 after 2 weeks (p= 0.037) and 3 months (0.025) than in group 2. USS was significantly lower in group 1 after 3 months of follow-up regarding the number of ulcers (p=0.014), ulcer size (p=0.022), and duration (p=0.009). In the BDCAF both groups showed an improvement after 3 months follow-up but insignificant between the two groups.
Interesting study in which topical tacrolimus seems to be a safe and an effective adjunctive therapy in the management of oral ulcerations in BD. In this study topical tacrolimus was combined with oral colchicine.
For me topical tacrolimus is a possible future therapeutic option in single or occasional oral and maybe also genital ulcers in BD.