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Comparative effect of tacrolimus 0.1% ointment and clobetasol 0.05% ointment in patients with oral lichen planus


  • Conflict of interest and source of funding statement The authors declare that they have no conflict of interests.
    This study was supported by grants from the Ministero Italiano University of Ricerca, Rome, Italy, to Prof. M. L. Pacor and Prof. G. Di Lorenzo. Funding was used to purchase study drugs and software. Clobetasol propionate 0.5% ointment was purchased from GlaxoSmithKline, Verona, Italy.

Prof. Gabriele Di Lorenzo
Dipartimento di Medicina Clinica e delle Patologie Emergenti
Università di Palermo
Via del Vespro
141 -90127 Palermo


Background: Oral lichen planus (OLP) is considered to be an autoimmune disease of unknown aetiology that affects the mucosae, especially the oral cavity.

Objective: We compared tacrolimus 0.1% ointment and clobetasol 0.05% ointment for the treatment of OLP.

Patients and Methods: A total of 32 patients (20 females and 12 males; all white, Italian origin, mean age of 43.6±18.4 years; 16 patients per treatment group) were treated with tacrolimus or clobetasol ointment for 4 weeks in a randomized, double-blind, clinical trial. Pain severity, burning sensation, and mucosal lesion extension were assessed using a four-point scale.

Results: At the end of the treatment period, symptom scores were significantly lower in the tacrolimus group than in the clobetasol group.

Conclusion: The results of this study suggest that tacrolimus 0.1% ointment is more effective than clobetasol propionate 0.05% ointment in the treatment of OLP. However, other studies are needed to confirm the effectiveness of this treatment before it can be recommended for use in clinical practice.