Topical tacrolimus orabase versus topical clobetasol propionate orabase in the treatment of symptomatic oral lichen planus: a pilot randomized study.

Objectives: This pilot study aimed to compare the efficacy of 0.1% tacrolimus and 0.05% clobetasol propionate in orabase for treating symptomatic oral lichen planus (OLP).

Materials and methods: Pilot, randomized, and controlled study conducted on 21 patients with symptomatic OLP, selected according to the clinical and histopathological criteria of Cheng et al. 2016. Twelve patients received 0.1% tacrolimus, and nine received 0.05% clobetasol, both in orabase for 30 days with a two-month follow-up. The patients were examined for scores of signs (ODSS), symptoms (VAS), quality of life (OHIP-14), anxiety (Beck Anxiety Scale), and treatment satisfaction (Hedonic Scale).

Results: Both treatments were effective in reducing ODSS, VAS, and Beck Anxiety Scale scores and performed well on the hedonic scale, yet without statistical difference between them. However, at the 1-month follow-up, patients in group Clobetasol showed a greater percentage reduction in ODSS score compared to baseline by 50% (p = 0.02) and significantly lower average values (p = 0.03) than those in group Tacrolimus. Longitudinal intragroup analysis revealed significant improvements over time in both groups for ODSS, and only in the tacrolimus group for OHIP-14 and Beck scores.

Conclusions: Both tested protocols were effective over a three-month follow-up. However, due to the lower cost of clobetasol propionate it can be considered the first-choice option. Tacrolimus in orabase formulation may be a promising alternative for refractory lesions that do not respond to topical steroids.

Clinical relevance: Managing symptomatic OLP is challenging. Comparisons between tacrolimus and clobetasol propionate in orabase formulations have not yet been thoroughly explored.